Trial Outcomes & Findings for S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer (NCT NCT02177695)
NCT ID: NCT02177695
Last Updated: 2024-09-19
Results Overview
The proportion of participants achieving pT0 in both favorable and unfavorable treatment specific-COXEN score categories. Unit of measure is the number of participants in each category that achieved pT0 \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
237 participants
Primary outcome timeframe
Up to 5 years post registration
Results posted on
2024-09-19
Participant Flow
237 participants were enrolled, but 10 were ineligible due to missing tissue, inadequate disease assessment and inadequate kidney function.
Participant milestones
| Measure |
Gemcitabine & Cisplatin
Gemcitabine, 1000 mg/m2, IV, Days 1\&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles
Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
Dose Dense MVAC
Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
|---|---|---|
|
ITT Analysis
STARTED
|
120
|
117
|
|
ITT Analysis
COMPLETED
|
115
|
112
|
|
ITT Analysis
NOT COMPLETED
|
5
|
5
|
|
Primary COXEN Analysis
STARTED
|
115
|
112
|
|
Primary COXEN Analysis
Participants Excluded From Primary COXEN Analysis
|
33
|
27
|
|
Primary COXEN Analysis
COMPLETED
|
82
|
85
|
|
Primary COXEN Analysis
NOT COMPLETED
|
33
|
27
|
Reasons for withdrawal
| Measure |
Gemcitabine & Cisplatin
Gemcitabine, 1000 mg/m2, IV, Days 1\&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles
Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
Dose Dense MVAC
Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
|---|---|---|
|
ITT Analysis
Ineligible
|
5
|
5
|
|
Primary COXEN Analysis
inadequate tissue submitted
|
5
|
6
|
|
Primary COXEN Analysis
insufficient amount of chemotherapy received
|
15
|
8
|
|
Primary COXEN Analysis
Pathologic response not evaluated
|
13
|
13
|
Baseline Characteristics
47 participants included in the ITT analysis (n=28 on the GC arm, n=19 on the ddMVAC arm) were not evaluable for the primary COXEN analysis and therefore did not have COXEN scores generated
Baseline characteristics by cohort
| Measure |
Gemcitabine & Cisplatin
n=115 Participants
Gemcitabine, 1000 mg/m2, IV, Days 1\&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles
Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
Dose Dense MVAC
n=112 Participants
Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
Total
n=227 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.9 years
n=115 Participants
|
64.8 years
n=112 Participants
|
64.8 years
n=227 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=115 Participants
|
13 Participants
n=112 Participants
|
36 Participants
n=227 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=115 Participants
|
99 Participants
n=112 Participants
|
191 Participants
n=227 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=115 Participants
|
5 Participants
n=112 Participants
|
12 Participants
n=227 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=115 Participants
|
105 Participants
n=112 Participants
|
209 Participants
n=227 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=115 Participants
|
2 Participants
n=112 Participants
|
6 Participants
n=227 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=115 Participants
|
1 Participants
n=112 Participants
|
1 Participants
n=227 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=115 Participants
|
1 Participants
n=112 Participants
|
5 Participants
n=227 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=115 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=227 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=115 Participants
|
1 Participants
n=112 Participants
|
8 Participants
n=227 Participants
|
|
Race (NIH/OMB)
White
|
94 Participants
n=115 Participants
|
107 Participants
n=112 Participants
|
201 Participants
n=227 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=115 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=227 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=115 Participants
|
2 Participants
n=112 Participants
|
12 Participants
n=227 Participants
|
|
Clinical stage
T2
|
102 Participants
n=115 Participants
|
98 Participants
n=112 Participants
|
200 Participants
n=227 Participants
|
|
Clinical stage
T3 or T4a
|
13 Participants
n=115 Participants
|
14 Participants
n=112 Participants
|
27 Participants
n=227 Participants
|
|
Zubrod performance status
0
|
88 Participants
n=115 Participants
|
86 Participants
n=112 Participants
|
174 Participants
n=227 Participants
|
|
Zubrod performance status
1
|
27 Participants
n=115 Participants
|
26 Participants
n=112 Participants
|
53 Participants
n=227 Participants
|
|
GC-COXEN score
Favorable
|
18 Participants
n=82 Participants • 47 participants included in the ITT analysis (n=28 on the GC arm, n=19 on the ddMVAC arm) were not evaluable for the primary COXEN analysis and therefore did not have COXEN scores generated
|
25 Participants
n=85 Participants • 47 participants included in the ITT analysis (n=28 on the GC arm, n=19 on the ddMVAC arm) were not evaluable for the primary COXEN analysis and therefore did not have COXEN scores generated
|
43 Participants
n=167 Participants • 47 participants included in the ITT analysis (n=28 on the GC arm, n=19 on the ddMVAC arm) were not evaluable for the primary COXEN analysis and therefore did not have COXEN scores generated
|
|
GC-COXEN score
Not favorable
|
64 Participants
n=82 Participants • 47 participants included in the ITT analysis (n=28 on the GC arm, n=19 on the ddMVAC arm) were not evaluable for the primary COXEN analysis and therefore did not have COXEN scores generated
|
60 Participants
n=85 Participants • 47 participants included in the ITT analysis (n=28 on the GC arm, n=19 on the ddMVAC arm) were not evaluable for the primary COXEN analysis and therefore did not have COXEN scores generated
|
124 Participants
n=167 Participants • 47 participants included in the ITT analysis (n=28 on the GC arm, n=19 on the ddMVAC arm) were not evaluable for the primary COXEN analysis and therefore did not have COXEN scores generated
|
|
ddMVAC-COXEN score
Favorable
|
23 Participants
n=82 Participants • 47 participants included in the ITT analysis (n=28 on the GC arm, n=19 on the ddMVAC arm) were not evaluable for the primary COXEN analysis and therefore did not have COXEN scores generated
|
30 Participants
n=85 Participants • 47 participants included in the ITT analysis (n=28 on the GC arm, n=19 on the ddMVAC arm) were not evaluable for the primary COXEN analysis and therefore did not have COXEN scores generated
|
53 Participants
n=167 Participants • 47 participants included in the ITT analysis (n=28 on the GC arm, n=19 on the ddMVAC arm) were not evaluable for the primary COXEN analysis and therefore did not have COXEN scores generated
|
|
ddMVAC-COXEN score
Not Favorable
|
59 Participants
n=82 Participants • 47 participants included in the ITT analysis (n=28 on the GC arm, n=19 on the ddMVAC arm) were not evaluable for the primary COXEN analysis and therefore did not have COXEN scores generated
|
55 Participants
n=85 Participants • 47 participants included in the ITT analysis (n=28 on the GC arm, n=19 on the ddMVAC arm) were not evaluable for the primary COXEN analysis and therefore did not have COXEN scores generated
|
114 Participants
n=167 Participants • 47 participants included in the ITT analysis (n=28 on the GC arm, n=19 on the ddMVAC arm) were not evaluable for the primary COXEN analysis and therefore did not have COXEN scores generated
|
PRIMARY outcome
Timeframe: Up to 5 years post registrationPopulation: Eligible participants that were evaluable for COXEN analysis
The proportion of participants achieving pT0 in both favorable and unfavorable treatment specific-COXEN score categories. Unit of measure is the number of participants in each category that achieved pT0 \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score.
Outcome measures
| Measure |
Gemcitabine & Cisplatin
n=82 Participants
Gemcitabine, 1000 mg/m2, IV, Days 1\&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles
Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
Dose Dense MVAC
n=85 Participants
Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
|---|---|---|
|
Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate
Favorable treatment-COXEN score
|
8 Participants
|
10 Participants
|
|
Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate
Unfavorable treatment-COXEN score
|
20 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: up to 5 years post-registrationPopulation: Eligible participants that were evaluable for COXEN analysis
The proportion of participants achieving \<=pT1 in both favorable and unfavorable treatment specific-COXEN score categories. Unit of measure is the number of participants in each category that achieved \<= pT1 \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score.
Outcome measures
| Measure |
Gemcitabine & Cisplatin
n=82 Participants
Gemcitabine, 1000 mg/m2, IV, Days 1\&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles
Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
Dose Dense MVAC
n=85 Participants
Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
|---|---|---|
|
Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate
Favorable treatment-COXEN score
|
10 Participants
|
16 Participants
|
|
Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate
Unfavorable treatment-COXEN score
|
30 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: up to 5 years post-registrationPopulation: Eligible participants that were evaluable for COXEN analysis. Participants in this arm were pooled to test the ability of the COXEN algorithm to distinguish between GC and ddMVAC treatment, with the assumption that there is no interaction between the COXEN score and treatment arm.
To assess in a hypothesis generating fashion, the ability of COXEN to select for an individual chemotherapy regimen (GC vs DDMVAC) P-values are reported as a measure of whether COXEN can select between GC/DDMVAC and to determine the significance of interactions between treatment specific COXEN scores and treatment arms in models predicting either pT0 or \<= pT1. Interactions with p-values \> 0.05 are interpreted as not significant. \_\_\_\_\_\_\_\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score.
Outcome measures
| Measure |
Gemcitabine & Cisplatin
n=167 Participants
Gemcitabine, 1000 mg/m2, IV, Days 1\&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles
Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
Dose Dense MVAC
Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
|---|---|---|
|
Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC
P-value of interaction term (GCscore*treatment arm) in model predicting pT0
|
0.88 p-value
|
—
|
|
Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC
P-value of interaction term (GCscore*treatment arm) in logistic regression model predicting <=pT1
|
0.43 p-value
|
—
|
|
Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC
P-value of interaction term (MVACscore*treatment arm) in logistic regression model predicting pT0
|
0.66 p-value
|
—
|
|
Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC
P-value of interaction term (MVACscore*treatment arm) in logistic regression model predicting <=pT1
|
0.85 p-value
|
—
|
PRIMARY outcome
Timeframe: up to 5 years post-registrationPopulation: Eligible participants that were evaluable for COXEN analysis. Participants in this arm were pooled to test the ability of the COXEN algorithm to distinguish between GC and ddMVAC treatment, with the assumption that there is no interaction between the COXEN score and treatment arm.
The Pearson and Spearman correlation coefficients for GC-and ddMVAC-COXEN score were calculated and are reported below. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: * By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . * By evaluating the correlation between the GC- and the DDMVAC-COXEN score.
Outcome measures
| Measure |
Gemcitabine & Cisplatin
n=167 Participants
Gemcitabine, 1000 mg/m2, IV, Days 1\&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles
Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
Dose Dense MVAC
Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
|---|---|---|
|
Correlation Between GC-and ddMVAC-COXEN Score
Spearman correlation coefficient
|
0.386 correlation coefficient
|
—
|
|
Correlation Between GC-and ddMVAC-COXEN Score
Pearson correlation coefficient
|
0.385 correlation coefficient
|
—
|
SECONDARY outcome
Timeframe: Up to 5 years post registrationPopulation: Eligible participants that were evaluable for COXEN analysis. Participants in this arm were pooled to test the ability of the COXEN algorithm to distinguish between GC and ddMVAC treatment, with the assumption that there is no interaction between the COXEN score and treatment arm.
In addition to stratification factors and dichotomous COXEN GEM score, an indicator for treatment arm and the interaction of treatment arm with COXEN GEM score was also included in a logistic regression model. A significant interaction would suggest that the respective COXEN GEM score was able to differentiate whether a patient was more likely to respond to one chemotherapy regimen over another. \*note that this is the same objective at Primary Outcome #3 above - this was erroneously listed twice in the protocol.
Outcome measures
| Measure |
Gemcitabine & Cisplatin
n=167 Participants
Gemcitabine, 1000 mg/m2, IV, Days 1\&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles
Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
Dose Dense MVAC
Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
|---|---|---|
|
Predictability of the CO-eXpression ExtrapolatioN (COXEN) Score to Direct Which of the Two Regimens the Patient Should Receive: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC)
Pvalue of interaction term (GCscore*treatment arm) in model predicting pT0
|
0.88 p-value
|
—
|
|
Predictability of the CO-eXpression ExtrapolatioN (COXEN) Score to Direct Which of the Two Regimens the Patient Should Receive: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC)
Pvalue of interaction term (GCscore*treatment arm) in model predicting <=pT1
|
0.43 p-value
|
—
|
|
Predictability of the CO-eXpression ExtrapolatioN (COXEN) Score to Direct Which of the Two Regimens the Patient Should Receive: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC)
Pvalue of interaction term (MVACscore*treatment arm) in model predicting pT0
|
0.66 p-value
|
—
|
|
Predictability of the CO-eXpression ExtrapolatioN (COXEN) Score to Direct Which of the Two Regimens the Patient Should Receive: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC)
Pvalue of interaction term (MVACscore*treatment arm) in model predicting <=pT1
|
0.85 p-value
|
—
|
SECONDARY outcome
Timeframe: Up to 5 years post registrationPopulation: Eligible participants across both arms that were evaluable for COXEN analysis.
5-year OS curve was estimated using the Kaplan-Meier method. Included all COXEN evaluable participants regardless of arm assignment. The report groups were favorable vs. unfavorable COXEN status.
Outcome measures
| Measure |
Gemcitabine & Cisplatin
n=167 Participants
Gemcitabine, 1000 mg/m2, IV, Days 1\&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles
Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
Dose Dense MVAC
Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
|---|---|---|
|
Value of Gene Expression Profiling in Predicting Overall Survival (OS)
Favorable COXEN Status
|
76 Percent of Participants
|
—
|
|
Value of Gene Expression Profiling in Predicting Overall Survival (OS)
Unfavorable COXEN Status
|
71 Percent of Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 5 years post-registrationPopulation: Participants who received treatment in Gemcitabine \& Cisplatin and Dose Dense MVAC arms.
Pathologic complete response rate at the time of cystectomy following GC or DDMVAC treatment
Outcome measures
| Measure |
Gemcitabine & Cisplatin
n=82 Participants
Gemcitabine, 1000 mg/m2, IV, Days 1\&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles
Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
Dose Dense MVAC
n=85 Participants
Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
|---|---|---|
|
Pathologic T0 Rate Evaluation: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC)
|
36 percentage of participants
|
42 percentage of participants
|
SECONDARY outcome
Timeframe: Duration of treatment and follow up until death or 5 years post registrationPopulation: Participants who received at least one dose of protocol treatment, submitted toxicity data and were included in the ITT analysis.
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Grade 3 is less severe than Grade 5. Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL\* (bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden). Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related to AE \*ADL- Activities of Daily Living
Outcome measures
| Measure |
Gemcitabine & Cisplatin
n=115 Participants
Gemcitabine, 1000 mg/m2, IV, Days 1\&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles
Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
Dose Dense MVAC
n=112 Participants
Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
|---|---|---|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anemia
|
10 Participants
|
9 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac arrest
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac disorders - Other, specify
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hematuria
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Insomnia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphocyte count decreased
|
2 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neutrophil count decreased
|
20 Participants
|
10 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vomiting
|
0 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypokalemia
|
0 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypertension
|
1 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypocalcemia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Acute kidney injury
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alanine aminotransferase increased
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bronchial infection
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Chronic kidney disease
|
2 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Creatinine increased
|
0 Participants
|
5 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dehydration
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Diarrhea
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dizziness
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspnea
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Enterocolitis infectious
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Erectile dysfunction
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Esophagitis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fall
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue
|
3 Participants
|
5 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Febrile neutropenia
|
2 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Headache
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Heart failure
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperglycemia
|
3 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperkalemia
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypomagnesemia
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyponatremia
|
5 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypophosphatemia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infections and infestations - Other, specify
|
0 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Investigations - Other, specify
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Kidney infection
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lung infection
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis oral
|
0 Participants
|
5 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nausea
|
1 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Phlebitis infective
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Platelet count decreased
|
11 Participants
|
5 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Proteinuria
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Renal and urinary disorders - Other, specify
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sepsis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Syncope
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Thromboembolic event
|
4 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Tinnitus
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Upper gastrointestinal hemorrhage
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Urinary tract infection
|
4 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Urinary tract obstruction
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vestibular disorder
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
White blood cell decreased
|
5 Participants
|
6 Participants
|
Adverse Events
Gemcitabine and Cisplatin
Serious events: 1 serious events
Other events: 112 other events
Deaths: 28 deaths
Dose Dense MVAC
Serious events: 4 serious events
Other events: 108 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Gemcitabine and Cisplatin
n=115 participants at risk
Gemcitabine, 1000 mg/m2, IV, Days 1 and 8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles
Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
Dose Dense MVAC
n=112 participants at risk
Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Cardiac disorders
Cardiac arrest
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
General disorders
Sudden death NOS
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Infections and infestations
Infections and infestations-Other
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Infections and infestations
Sepsis
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
Other adverse events
| Measure |
Gemcitabine and Cisplatin
n=115 participants at risk
Gemcitabine, 1000 mg/m2, IV, Days 1 and 8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles
Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
Dose Dense MVAC
n=112 participants at risk
Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles
Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
|
|---|---|---|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.6%
3/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
2.7%
3/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Blood and lymphatic system disorders
Anemia
|
72.2%
83/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
61.6%
69/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
1.7%
2/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.7%
2/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Cardiac disorders
Cardiac disorders-Other
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Cardiac disorders
Chest pain - cardiac
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Cardiac disorders
Heart failure
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Cardiac disorders
Myocardial infarction
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Cardiac disorders
Palpitations
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Cardiac disorders
Sinus bradycardia
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Cardiac disorders
Sinus tachycardia
|
7.8%
9/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
2.7%
3/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders-Other
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Ear and labyrinth disorders
Ear pain
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Ear and labyrinth disorders
Hearing impaired
|
3.5%
4/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
6.2%
7/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Ear and labyrinth disorders
Tinnitus
|
15.7%
18/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
22.3%
25/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Eye disorders
Blurred vision
|
5.2%
6/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
5.4%
6/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Eye disorders
Conjunctivitis
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Eye disorders
Dry eye
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Eye disorders
Eye disorders-Other
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Eye disorders
Photophobia
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Eye disorders
Watering eyes
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
7.1%
8/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Abdominal pain
|
10.4%
12/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
8.9%
10/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Constipation
|
40.9%
47/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
41.1%
46/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Diarrhea
|
16.5%
19/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
24.1%
27/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Dry mouth
|
1.7%
2/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
3.6%
4/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Dyspepsia
|
5.2%
6/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
8.9%
10/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
2/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Flatulence
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
9.6%
11/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
14.3%
16/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
3.5%
4/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
3.6%
4/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Gastroparesis
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Mucositis oral
|
10.4%
12/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
34.8%
39/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Nausea
|
56.5%
65/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
64.3%
72/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Oral pain
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
3.6%
4/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Stomach pain
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Gastrointestinal disorders
Vomiting
|
15.7%
18/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
25.0%
28/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
General disorders
Chills
|
3.5%
4/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
3.6%
4/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
General disorders
Edema face
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
General disorders
Edema limbs
|
13.9%
16/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
11.6%
13/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
General disorders
Fatigue
|
71.3%
82/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
68.8%
77/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
General disorders
Fever
|
10.4%
12/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
4.5%
5/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
General disorders
Flu like symptoms
|
4.3%
5/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
General disorders
General disorders and admin site conditions - Other
|
3.5%
4/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
3.6%
4/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
General disorders
Infusion related reaction
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
General disorders
Infusion site extravasation
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
General disorders
Injection site reaction
|
3.5%
4/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
General disorders
Irritability
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
General disorders
Localized edema
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
General disorders
Malaise
|
1.7%
2/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
General disorders
Non-cardiac chest pain
|
3.5%
4/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
2.7%
3/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
General disorders
Pain
|
6.1%
7/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
7.1%
8/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Immune system disorders
Allergic reaction
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Infections and infestations
Bladder infection
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Infections and infestations
Eye infection
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Infections and infestations
Infections and infestations-Other
|
1.7%
2/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
4.5%
5/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Infections and infestations
Kidney infection
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Infections and infestations
Lung infection
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Infections and infestations
Phlebitis infective
|
1.7%
2/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Infections and infestations
Rash pustular
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Infections and infestations
Sepsis
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Infections and infestations
Sinusitis
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Infections and infestations
Skin infection
|
1.7%
2/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
2.7%
3/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Infections and infestations
Tooth infection
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Infections and infestations
Upper respiratory infection
|
2.6%
3/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Infections and infestations
Urinary tract infection
|
14.8%
17/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
9.8%
11/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Injury, poisoning and procedural complications
Bruising
|
3.5%
4/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Injury, poisoning and procedural complications
Fall
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Investigations
Alanine aminotransferase increased
|
8.7%
10/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
7.1%
8/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Investigations
Alkaline phosphatase increased
|
13.9%
16/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
20.5%
23/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Investigations
Aspartate aminotransferase increased
|
5.2%
6/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
6.2%
7/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Investigations
Cholesterol high
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Investigations
Creatinine increased
|
29.6%
34/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
33.0%
37/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Investigations
Hemoglobin increased
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Investigations
Investigations-Other
|
3.5%
4/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
2.7%
3/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Investigations
Lymphocyte count decreased
|
15.7%
18/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
14.3%
16/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Investigations
Neutrophil count decreased
|
38.3%
44/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
13.4%
15/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Investigations
Platelet count decreased
|
43.5%
50/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
33.0%
37/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Investigations
Weight gain
|
4.3%
5/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Investigations
Weight loss
|
9.6%
11/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
9.8%
11/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Investigations
White blood cell decreased
|
36.5%
42/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
12.5%
14/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Metabolism and nutrition disorders
Anorexia
|
24.3%
28/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
31.2%
35/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Metabolism and nutrition disorders
Dehydration
|
8.7%
10/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
8.0%
9/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.7%
25/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
25.9%
29/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.7%
10/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
8.9%
10/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
2.7%
3/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.3%
13/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
21.4%
24/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.8%
9/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
14.3%
16/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.6%
3/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.6%
11/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
17.9%
20/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
30.4%
35/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
33.9%
38/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Metabolism and nutrition disorders
Hyponatremia
|
21.7%
25/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
25.9%
29/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.8%
9/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
6.2%
7/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
2.7%
3/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Metabolism and nutrition disorders
Obesity
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
9/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
11.6%
13/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
10/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
8.9%
10/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.6%
11/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
7.1%
8/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.7%
2/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
9.6%
11/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
8.0%
9/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tiss disorder - Other
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
5/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
3.6%
4/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.6%
11/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
6.2%
7/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Nervous system disorders
Amnesia
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Nervous system disorders
Concentration impairment
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Nervous system disorders
Dizziness
|
13.0%
15/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
15.2%
17/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Nervous system disorders
Dysgeusia
|
16.5%
19/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
21.4%
24/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Nervous system disorders
Headache
|
15.7%
18/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
17.0%
19/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Nervous system disorders
Memory impairment
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Nervous system disorders
Nervous system disorders-Other
|
1.7%
2/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Nervous system disorders
Paresthesia
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
2.7%
3/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.6%
3/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.6%
11/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
12.5%
14/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Nervous system disorders
Presyncope
|
1.7%
2/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Nervous system disorders
Somnolence
|
2.6%
3/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
3.6%
4/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Nervous system disorders
Stroke
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Nervous system disorders
Syncope
|
2.6%
3/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Nervous system disorders
Tremor
|
2.6%
3/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Psychiatric disorders
Agitation
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Psychiatric disorders
Anxiety
|
11.3%
13/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
2.7%
3/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Psychiatric disorders
Confusion
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Psychiatric disorders
Depression
|
6.1%
7/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
2.7%
3/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Psychiatric disorders
Insomnia
|
20.0%
23/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
14.3%
16/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Psychiatric disorders
Libido decreased
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Psychiatric disorders
Psychiatric disorders-Other
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Renal and urinary disorders
Acute kidney injury
|
5.2%
6/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
6.2%
7/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Renal and urinary disorders
Bladder spasm
|
1.7%
2/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Renal and urinary disorders
Chronic kidney disease
|
5.2%
6/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
2.7%
3/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Renal and urinary disorders
Cystitis noninfective
|
2.6%
3/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Renal and urinary disorders
Hematuria
|
14.8%
17/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
11.6%
13/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Renal and urinary disorders
Proteinuria
|
3.5%
4/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Renal and urinary disorders
Renal and urinary disorders-Other
|
3.5%
4/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
2.7%
3/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Renal and urinary disorders
Urinary frequency
|
12.2%
14/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
3.6%
4/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Renal and urinary disorders
Urinary incontinence
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Renal and urinary disorders
Urinary retention
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Renal and urinary disorders
Urinary tract pain
|
6.1%
7/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
7.1%
8/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Renal and urinary disorders
Urinary urgency
|
1.7%
2/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.6%
3/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
7/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
8.9%
10/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.3%
13/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
5.4%
6/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.5%
4/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
9.8%
11/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
11.3%
13/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
11.6%
13/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
4.5%
5/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
2.7%
3/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.7%
2/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic and mediastinal disorders - Other
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.6%
3/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
5.4%
6/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.5%
19/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
42.9%
48/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.5%
4/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.7%
2/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
2.7%
3/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.0%
8/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
5.4%
6/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
3.5%
4/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
6.2%
7/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Social circumstances
Social circumstances-Other
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Vascular disorders
Flushing
|
0.87%
1/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Vascular disorders
Hot flashes
|
1.7%
2/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
2.7%
3/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Vascular disorders
Hypertension
|
20.0%
23/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
26.8%
30/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Vascular disorders
Hypotension
|
4.3%
5/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
1.8%
2/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Vascular disorders
Phlebitis
|
1.7%
2/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Vascular disorders
Superficial thrombophlebitis
|
1.7%
2/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.00%
0/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Vascular disorders
Thromboembolic event
|
9.6%
11/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
3.6%
4/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
|
Vascular disorders
Vascular disorders-Other
|
0.00%
0/115 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
0.89%
1/112 • Duration of treatment and follow up until death or 5 years post registration
Participants who received protocol treatment and are included in the ITT analysis
|
Additional Information
Genitourinary Committee Statistician
SWOG Statistics and Data Management Center
Phone: 2066674623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60