Trial Outcomes & Findings for Carboplatin and Paclitaxel Combined With Cetuximab and/or IMC-A12 in Patients With Advanced Non-Small Cell Lung Cancer (NCT NCT00986674)
NCT ID: NCT00986674
Last Updated: 2014-09-26
Results Overview
Progression free survival is defined as time from registration to disease progression or death from any cause, whichever occurred earlier. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions . All eligible and treated patients were included in the analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
140 participants
Primary outcome timeframe
Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3
Results posted on
2014-09-26
Participant Flow
This study was activated on September 11, 2009. The trial was suspended to accrual on December 17, 2010 after accruing 140 patients and accrual was subsequently terminated on April 19, 2011 due to excessive grade 5 events within 30 days of study registration.
Participant milestones
| Measure |
Arm I (Carboplatin, Paclitaxel, Cetuximab)
Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV
|
Arm II (Carboplatin, Paclitaxel, Cixutumumab)
Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV
|
Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)
Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
45
|
48
|
|
Overall Study
Treated
|
43
|
42
|
47
|
|
Overall Study
Eligible and Treated
|
39
|
41
|
47
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
47
|
45
|
48
|
Reasons for withdrawal
| Measure |
Arm I (Carboplatin, Paclitaxel, Cetuximab)
Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV
|
Arm II (Carboplatin, Paclitaxel, Cixutumumab)
Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV
|
Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)
Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
28
|
25
|
23
|
|
Overall Study
Adverse Event
|
4
|
8
|
9
|
|
Overall Study
Death
|
5
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
1
|
|
Overall Study
alternative therapy
|
0
|
0
|
1
|
|
Overall Study
not start protocol therapy
|
4
|
3
|
1
|
|
Overall Study
unknown/not specify
|
0
|
7
|
9
|
Baseline Characteristics
Carboplatin and Paclitaxel Combined With Cetuximab and/or IMC-A12 in Patients With Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Carboplatin, Paclitaxel, Cetuximab)
n=39 Participants
Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV
|
Arm II (Carboplatin, Paclitaxel, Cixutumumab)
n=41 Participants
Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV
|
Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)
n=47 Participants
Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60 years
n=93 Participants
|
60 years
n=4 Participants
|
60 years
n=27 Participants
|
60 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
58 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
69 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3Population: eligible and treated patients
Progression free survival is defined as time from registration to disease progression or death from any cause, whichever occurred earlier. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions . All eligible and treated patients were included in the analysis.
Outcome measures
| Measure |
Arm I (Carboplatin, Paclitaxel, Cetuximab)
n=39 Participants
Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV
|
Arm II (Carboplatin, Paclitaxel, Cixutumumab)
n=41 Participants
Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV
|
Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)
n=47 Participants
Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV
|
|---|---|---|---|
|
Progression Free Survival
|
3.4 months
Interval 2.6 to 5.8
|
4.2 months
Interval 3.5 to 5.3
|
4.0 months
Interval 3.2 to 5.4
|
SECONDARY outcome
Timeframe: assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3Population: eligible and treated patients
Overall survival is defined as time from registration to death from any cause.
Outcome measures
| Measure |
Arm I (Carboplatin, Paclitaxel, Cetuximab)
n=39 Participants
Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV
|
Arm II (Carboplatin, Paclitaxel, Cixutumumab)
n=41 Participants
Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV
|
Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)
n=47 Participants
Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV
|
|---|---|---|---|
|
Overall Survival
|
9.8 months
Interval 7.4 to 17.2
|
7.7 months
Interval 5.8 to 11.5
|
8.8 months
Interval 7.2 to 14.9
|
SECONDARY outcome
Timeframe: Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3Population: eligible and treated patients who have response data. 3 patients on arm I and 1 patient on arm III had unknown/missing tumor response and were excluded from the analysis
Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Complete response (CR) was defined disappearance of all tumor lesions. Partial response (PR) was defined as as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. Overall response rate= CR+PR.
Outcome measures
| Measure |
Arm I (Carboplatin, Paclitaxel, Cetuximab)
n=36 Participants
Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV
|
Arm II (Carboplatin, Paclitaxel, Cixutumumab)
n=41 Participants
Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV
|
Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)
n=46 Participants
Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
cixutumumab: Given IV
carboplatin: Given IV
paclitaxel: Given IV
cetuximab: Given IV
|
|---|---|---|---|
|
Response Rate
|
11.1 percentage of participants
Interval 3.1 to 26.1
|
22.0 percentage of participants
Interval 10.6 to 37.6
|
21.7 percentage of participants
Interval 10.9 to 36.4
|
Adverse Events
Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)
Serious events: 36 serious events
Other events: 46 other events
Deaths: 0 deaths
Arm I (Carboplatin, Paclitaxel, Cetuximab)
Serious events: 27 serious events
Other events: 43 other events
Deaths: 0 deaths
Arm II (Carboplatin, Paclitaxel, Cixutumumab)
Serious events: 27 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)
n=48 participants at risk
Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
|
Arm I (Carboplatin, Paclitaxel, Cetuximab)
n=44 participants at risk
Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Carboplatin, Paclitaxel, Cixutumumab)
n=42 participants at risk
Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
6/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
13.6%
6/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
7.1%
3/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.2%
2/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
6.8%
3/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.8%
2/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.3%
1/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
General disorders
Edema face
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.4%
1/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
General disorders
Fatigue
|
10.4%
5/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
11.4%
5/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
16.7%
7/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
General disorders
Pain
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.3%
4/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.5%
2/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.3%
1/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.8%
2/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
3/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.4%
1/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.3%
1/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.4%
1/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
4/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
11.4%
5/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
7.1%
3/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
2/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
6.8%
3/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.4%
1/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Immune system disorders
Allergic reaction
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Immune system disorders
Anaphylaxis
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.4%
1/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Infections and infestations
Catheter related infection
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Infections and infestations
Lung infection
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
9.1%
4/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.4%
1/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Infections and infestations
Paronychia
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.3%
1/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Lymphocyte count decreased
|
4.2%
2/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.3%
1/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.8%
2/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Neutrophil count decreased
|
41.7%
20/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
27.3%
12/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
31.0%
13/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Infections and infestations
Sepsis
|
4.2%
2/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.4%
1/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Infections and infestations
Infections and infestations - Other
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.3%
1/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.8%
2/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Cardiac troponin I increased
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Lipase increased
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.3%
1/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Platelet count decreased
|
8.3%
4/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
6.8%
3/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
11.9%
5/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Urine output decreased
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Weight loss
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
White blood cell decreased
|
16.7%
8/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
18.2%
8/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
14.3%
6/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Acidosis
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.2%
2/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.5%
2/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
9.5%
4/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
3/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.3%
1/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.8%
2/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.4%
1/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.6%
7/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
9.5%
4/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.4%
1/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.5%
2/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
3/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.8%
2/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.5%
2/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.2%
3/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.4%
1/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
3/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.5%
2/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
7.1%
3/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
2/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.5%
2/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.3%
1/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
7.1%
3/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.3%
1/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.4%
1/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.4%
1/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.5%
2/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Eye disorders
Retinopathy
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
3/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.5%
2/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.8%
2/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
3/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.3%
1/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.4%
1/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.5%
2/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Vascular disorders
Hypotension
|
4.2%
2/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.3%
1/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
7.1%
3/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
Other adverse events
| Measure |
Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)
n=48 participants at risk
Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
|
Arm I (Carboplatin, Paclitaxel, Cetuximab)
n=44 participants at risk
Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Carboplatin, Paclitaxel, Cixutumumab)
n=42 participants at risk
Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
60.4%
29/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
65.9%
29/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
66.7%
28/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
General disorders
Chills
|
14.6%
7/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
6.8%
3/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
16.7%
7/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
General disorders
Edema limbs
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
9.1%
4/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
General disorders
Fatigue
|
77.1%
37/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
70.5%
31/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
71.4%
30/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
General disorders
Fever
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
9.1%
4/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.8%
2/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
27.1%
13/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
36.4%
16/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
52.4%
22/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.4%
5/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
18.2%
8/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
11.9%
5/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
6.2%
3/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.4%
1/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
8.3%
4/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.3%
1/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia
|
8.3%
4/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.5%
2/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.1%
13/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
27.3%
12/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
14.3%
6/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
60.4%
29/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
68.2%
30/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
14.3%
6/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
22.9%
11/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
22.7%
10/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
7.1%
3/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
8/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
20.5%
9/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
23.8%
10/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Gastrointestinal disorders
Diarrhea
|
39.6%
19/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
38.6%
17/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
35.7%
15/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
4/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
11.4%
5/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
9.5%
4/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Gastrointestinal disorders
Mucositis oral
|
43.8%
21/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
36.4%
16/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
26.2%
11/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Gastrointestinal disorders
Nausea
|
41.7%
20/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
45.5%
20/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
64.3%
27/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Gastrointestinal disorders
Vomiting
|
27.1%
13/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
22.7%
10/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
33.3%
14/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
4/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
15.9%
7/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.8%
2/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
6/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
13.6%
6/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
11.9%
5/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
4/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
6.8%
3/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
7.1%
3/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Cholesterol high
|
14.6%
7/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
11.9%
5/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Creatinine increased
|
4.2%
2/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
11.9%
5/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Lipase increased
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
7.1%
3/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Lymphocyte count decreased
|
10.4%
5/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
9.1%
4/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Neutrophil count decreased
|
12.5%
6/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
20.5%
9/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
28.6%
12/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Platelet count decreased
|
39.6%
19/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
29.5%
13/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
33.3%
14/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Serum amylase increased
|
4.2%
2/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
6.8%
3/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.8%
2/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Weight loss
|
39.6%
19/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
27.3%
12/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
35.7%
15/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
White blood cell decreased
|
20.8%
10/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
22.7%
10/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
23.8%
10/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Investigations
Investigations - Other, specify
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
9.5%
4/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Anorexia
|
52.1%
25/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
38.6%
17/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
54.8%
23/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
4/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
6.8%
3/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
7.1%
3/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
12.5%
6/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.3%
1/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
16.7%
7/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.9%
11/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
18.2%
8/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
38.1%
16/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.3%
1/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
7.1%
3/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
20.8%
10/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.5%
2/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
21.4%
9/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.2%
2/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
11.4%
5/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
7.1%
3/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.4%
5/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
20.5%
9/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
11.9%
5/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
4/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
15.9%
7/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.8%
2/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
35.4%
17/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
29.5%
13/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
16.7%
7/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
8/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
11.4%
5/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
21.4%
9/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
6.8%
3/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.8%
2/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
27.1%
13/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
25.0%
11/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
31.0%
13/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
12/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
31.8%
14/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
28.6%
12/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
3/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
9.1%
4/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
11.9%
5/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Nervous system disorders
Dizziness
|
10.4%
5/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
6.8%
3/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
14.3%
6/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
8/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
18.2%
8/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
16.7%
7/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Nervous system disorders
Headache
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
13.6%
6/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
4.8%
2/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
37.5%
18/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
43.2%
19/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
47.6%
20/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Eye disorders
Flashing lights
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
7.1%
3/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Eye disorders
Floaters
|
2.1%
1/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
11.9%
5/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Psychiatric disorders
Insomnia
|
6.2%
3/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
6.8%
3/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.4%
1/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.2%
3/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.3%
1/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
11.9%
5/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
8/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
22.7%
10/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
19.0%
8/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.8%
9/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
18.2%
8/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
19.0%
8/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.4%
5/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
11.4%
5/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
9.5%
4/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.2%
2/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
6.8%
3/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Renal and urinary disorders
Hematuria
|
6.2%
3/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.3%
1/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
0.00%
0/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
|
Vascular disorders
Hypotension
|
10.4%
5/48 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
2.3%
1/44 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
7.1%
3/42 • Assessed every cycle (6 weeks) while on treatment and for 30 days after the end of treatment.
After off treatment, patients were assessed every 3 months if \<2 years and every 6 months in year 3 to report any reportable long-term toxicity occurring prior to diagnosis of progression/relapse that has not been previously reported.
|
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