Trial Outcomes & Findings for Observational Study of Bevacizumab [Avastin] in Patients With Metastatic Colorectal Cancer (AVASTART) (NCT NCT01089413)
NCT ID: NCT01089413
Last Updated: 2015-12-16
Results Overview
Duration of bevacizumab treatment (in months) was defined as: (last treatment date - first treatment date plus \[+\] 1)/30.44. Duration of treatment was estimated using Kaplan-Meier method. Results are reported as per age groups (\<70 years and greater than or equal to \[≥\] 70 years) as well as for overall participants.
Recruitment status
COMPLETED
Target enrollment
201 participants
Primary outcome timeframe
Baseline up to end of treatment (up to approximately 3 years)
Results posted on
2015-12-16
Participant Flow
Participant milestones
| Measure |
Bevacizumab: Overall
All participants with Metastatic Colorectal Cancer (mCRC) for whom the physician decided to prescribe bevacizumab (Avastin) as part of their first line treatment and in line with current Summary of Product Characteristics (SmPC) (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
|---|---|
|
Overall Study
STARTED
|
201
|
|
Overall Study
Received Bevacizumab in First Line
|
199
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
201
|
Reasons for withdrawal
| Measure |
Bevacizumab: Overall
All participants with Metastatic Colorectal Cancer (mCRC) for whom the physician decided to prescribe bevacizumab (Avastin) as part of their first line treatment and in line with current Summary of Product Characteristics (SmPC) (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Progressive Disease
|
93
|
|
Overall Study
Participant Withdrew Consent
|
1
|
|
Overall Study
Unacceptable Toxicity
|
12
|
|
Overall Study
Death
|
10
|
|
Overall Study
Metastasectomy
|
13
|
|
Overall Study
Other
|
71
|
Baseline Characteristics
Observational Study of Bevacizumab [Avastin] in Patients With Metastatic Colorectal Cancer (AVASTART)
Baseline characteristics by cohort
| Measure |
Bevacizumab: Age <70 Years
n=120 Participants
Participants aged less than (\<) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
Bevacizumab: Age 70-80 Years
n=66 Participants
Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
Bevacizumab: Age >80 Years
n=13 Participants
Participants aged greater than (\>) 80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
74.3 years
STANDARD_DEVIATION 2.7 • n=7 Participants
|
83.8 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to end of treatment (up to approximately 3 years)Population: FAS.
Duration of bevacizumab treatment (in months) was defined as: (last treatment date - first treatment date plus \[+\] 1)/30.44. Duration of treatment was estimated using Kaplan-Meier method. Results are reported as per age groups (\<70 years and greater than or equal to \[≥\] 70 years) as well as for overall participants.
Outcome measures
| Measure |
Bevacizumab: Age <70 Years
n=120 Participants
Participants aged \< 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
Bevacizumab: Age ≥70 Years
n=79 Participants
Participants aged greater than or equal to (≥) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. Due to the small number of participants aged \>80 years, the age groups "70-80 Years" and "\>80 Years" have been pooled in this group.
|
Bevacizumab: Overall
n=199 Participants
All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
Bevacizumab: Overall
All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
|---|---|---|---|---|
|
Duration of Bevacizumab Treatment
|
6.50 months
Interval 5.26 to 7.39
|
5.09 months
Interval 3.48 to 6.24
|
5.95 months
Interval 5.09 to 6.8
|
—
|
SECONDARY outcome
Timeframe: Baseline up to disease progression or death (up to approximately 3 years)Population: FAS.
PFS (in months) was defined as: (date of progression or censored date - first date of treatment + 1)/30.44. Date of progression was derived from Response Evaluation Criteria in Solid Tumors (RECIST) evaluation or from last available date for participant who withdrew the study for progressive disease without progression according to RECIST evaluation. Progression was defined (as per RECIST) as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier method. Results are reported as per age groups (\<70 years and ≥70 years) as well as for overall participants.
Outcome measures
| Measure |
Bevacizumab: Age <70 Years
n=120 Participants
Participants aged \< 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
Bevacizumab: Age ≥70 Years
n=79 Participants
Participants aged greater than or equal to (≥) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. Due to the small number of participants aged \>80 years, the age groups "70-80 Years" and "\>80 Years" have been pooled in this group.
|
Bevacizumab: Overall
n=199 Participants
All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
Bevacizumab: Overall
All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
11.47 months
Interval 9.72 to 13.63
|
12.68 months
Interval 7.88 to 19.84
|
11.53 months
Interval 9.86 to 13.73
|
—
|
SECONDARY outcome
Timeframe: Baseline up to disease progression or death (up to approximately 3 years)Population: FAS. Here, number of participants analyzed = participants with available data for this outcome.
Tumor response was assessed using RECIST. Complete Response (CR): disappearance of all target and non-target lesions; Partial Response (PR): at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. Results are reported as per age groups (\<70 years, 70-80 years, and \>80 years) as well as for overall participants.
Outcome measures
| Measure |
Bevacizumab: Age <70 Years
n=107 Participants
Participants aged \< 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
Bevacizumab: Age ≥70 Years
n=58 Participants
Participants aged greater than or equal to (≥) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. Due to the small number of participants aged \>80 years, the age groups "70-80 Years" and "\>80 Years" have been pooled in this group.
|
Bevacizumab: Overall
n=13 Participants
All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
Bevacizumab: Overall
n=178 Participants
All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
|---|---|---|---|---|
|
Percentage of Participants With Best Overall Response
CR
|
3.7 percentage of participants
|
3.4 percentage of participants
|
7.7 percentage of participants
|
3.9 percentage of participants
|
|
Percentage of Participants With Best Overall Response
PR
|
43.9 percentage of participants
|
46.6 percentage of participants
|
53.8 percentage of participants
|
45.5 percentage of participants
|
|
Percentage of Participants With Best Overall Response
PD
|
5.6 percentage of participants
|
12.1 percentage of participants
|
15.4 percentage of participants
|
8.4 percentage of participants
|
|
Percentage of Participants With Best Overall Response
SD
|
46.7 percentage of participants
|
36.2 percentage of participants
|
23.1 percentage of participants
|
41.6 percentage of participants
|
|
Percentage of Participants With Best Overall Response
Not Evaluable
|
0.0 percentage of participants
|
1.7 percentage of participants
|
0.0 percentage of participants
|
0.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 51 (1 cycle = 21 days)Population: FAS. Here, number of participants analyzed = participants with available data for this outcome and n = participants with available data for specified category, for each arm, respectively. No participants were evaluable for Cycles 48-50; hence, no data reported for these cycles.
ECOG performance status measured on a 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=Dead. 0=Best status, 5=Worst status. For each time-point, only categories with available data are reported.
Outcome measures
| Measure |
Bevacizumab: Age <70 Years
n=108 Participants
Participants aged \< 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
Bevacizumab: Age ≥70 Years
n=63 Participants
Participants aged greater than or equal to (≥) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. Due to the small number of participants aged \>80 years, the age groups "70-80 Years" and "\>80 Years" have been pooled in this group.
|
Bevacizumab: Overall
n=9 Participants
All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
Bevacizumab: Overall
n=180 Participants
All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
|---|---|---|---|---|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline: ECOG 1 (n=108,63,9,180)
|
44.4 percentage of participants
|
46.0 percentage of participants
|
77.8 percentage of participants
|
46.7 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 1: ECOG 0 (n=101,58,9,168)
|
47.5 percentage of participants
|
39.7 percentage of participants
|
22.2 percentage of participants
|
43.5 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 5: ECOG 2 (n=88,36,6,130)
|
2.3 percentage of participants
|
11.1 percentage of participants
|
16.7 percentage of participants
|
5.4 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 6: ECOG 2 (n=75,36,5,116)
|
4.0 percentage of participants
|
8.3 percentage of participants
|
0.0 percentage of participants
|
5.2 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 7: ECOG 0 (n=67,31,6,104)
|
52.2 percentage of participants
|
48.4 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 8: ECOG 0 (n=63,26,5,94)
|
55.6 percentage of participants
|
34.6 percentage of participants
|
20.0 percentage of participants
|
47.9 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 8: ECOG 1 (n=63,26,5,94)
|
39.7 percentage of participants
|
61.5 percentage of participants
|
60.0 percentage of participants
|
46.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 8: ECOG 2 (n=63,26,5,94)
|
4.8 percentage of participants
|
3.8 percentage of participants
|
20.0 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 9: ECOG 1 (n=62,27,4,93)
|
45.2 percentage of participants
|
51.9 percentage of participants
|
50.0 percentage of participants
|
47.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 11: ECOG 1 (n=54,21,4,79)
|
38.9 percentage of participants
|
57.1 percentage of participants
|
50.0 percentage of participants
|
44.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 11: ECOG 2 (n=54,21,4,79)
|
3.7 percentage of participants
|
0.0 percentage of participants
|
25.0 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 12: ECOG 1 (n=48,21,3,72)
|
35.4 percentage of participants
|
52.4 percentage of participants
|
66.7 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 12: ECOG 2 (n=48,21,3,72)
|
6.3 percentage of participants
|
0.0 percentage of participants
|
33.3 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 14: ECOG 2 (n=34,15,1,50)
|
2.9 percentage of participants
|
6.7 percentage of participants
|
0.0 percentage of participants
|
4.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 16: ECOG 0 (n=28,13,1,42)
|
57.1 percentage of participants
|
38.5 percentage of participants
|
0.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 16: ECOG 1 (n=28,13,1,42)
|
42.9 percentage of participants
|
61.5 percentage of participants
|
100.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 17: ECOG 1 (n=24,11,1,36)
|
41.7 percentage of participants
|
54.5 percentage of participants
|
100.0 percentage of participants
|
47.2 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 20: ECOG 0 (n=15,6,0,21)
|
53.3 percentage of participants
|
33.3 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
47.6 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 20: ECOG 1 (n=15,6,0,21)
|
46.7 percentage of participants
|
66.7 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
52.4 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 21: ECOG 1 (n=15,5,0,20)
|
26.7 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
45.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 22: ECOG 0 (n=16,5,0,21)
|
50.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
38.1 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 23: ECOG 0 (n=12,5,0,17)
|
50.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
35.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 24: ECOG 1 (n=10,5,0,15)
|
30.0 percentage of participants
|
60.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
40.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 25: ECOG 0 (n=9,4,0,13)
|
77.8 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
53.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 26: ECOG 1 (n=9,4,0,13)
|
22.2 percentage of participants
|
75.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
38.5 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 28: ECOG 1 (n=5,4,0,9)
|
20.0 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
55.6 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 29: ECOG 0 (n=6,4,0,10)
|
83.3 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
50.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 29: ECOG 1 (n=6,4,0,10)
|
16.7 percentage of participants
|
75.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
40.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 29: ECOG 2 (n=6,4,0,10)
|
0.0 percentage of participants
|
25.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
10.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 32: ECOG 0 (n=5,3,0,8)
|
100.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
62.5 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 40: ECOG 2 (n=3,1,0,4)
|
33.3 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
25.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 42: ECOG 0 (n=3,0,0,3)
|
33.3 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
NA percentage of participants
Data not available as no participant was evaluable.
|
33.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 34: ECOG 0 (n=5,3,0,8)
|
80.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
50.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline: ECOG 2 (n=108,63,9,180)
|
6.5 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
7.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline: ECOG 0 (n=108,63,9,180)
|
47.2 percentage of participants
|
41.3 percentage of participants
|
22.2 percentage of participants
|
43.9 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 39: ECOG 0 (n=4,1,0,5)
|
50.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
40.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 39: ECOG 1 (n=4,1,0,5)
|
25.0 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
40.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 39: ECOG 2 (n=4,1,0,5)
|
25.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
20.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 40: ECOG 0 (n=3,1,0,4)
|
66.7 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
50.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 40: ECOG 1 (n=3,1,0,4)
|
0.0 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
25.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 41: ECOG 0 (n=2,0,0,2)
|
50.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
NA percentage of participants
Data not available as no participant was evaluable.
|
50.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 41: ECOG 2 (n=2,0,0,2)
|
50.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
NA percentage of participants
Data not available as no participant was evaluable.
|
50.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 42: ECOG 1 (n=3,0,0,3)
|
33.3 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
NA percentage of participants
Data not available as no participant was evaluable.
|
33.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 42: ECOG 2 (n=3,0,0,3)
|
33.3 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
NA percentage of participants
Data not available as no participant was evaluable.
|
33.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline: ECOG 3 (n=108,63,9,180)
|
0.0 percentage of participants
|
1.6 percentage of participants
|
0.0 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline: ECOG 4 (n=108,63,9,180)
|
1.9 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 1: ECOG 1 (n=101,58,9,168)
|
43.6 percentage of participants
|
51.7 percentage of participants
|
77.8 percentage of participants
|
48.2 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 1: ECOG 2 (n=101,58,9,168)
|
8.9 percentage of participants
|
6.9 percentage of participants
|
0.0 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 1: ECOG 3 (n=101,58,9,168)
|
0.0 percentage of participants
|
1.7 percentage of participants
|
0.0 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 2: ECOG 0 (n=98,54,8,160)
|
44.9 percentage of participants
|
38.9 percentage of participants
|
37.5 percentage of participants
|
42.5 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 2: ECOG 1 (n=98,54,8,160)
|
46.9 percentage of participants
|
50.0 percentage of participants
|
62.5 percentage of participants
|
48.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 2: ECOG 2 (n=98,54,8,160)
|
8.2 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
8.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 3: ECOG 0 (n=94,48,7,149)
|
50.0 percentage of participants
|
41.7 percentage of participants
|
42.9 percentage of participants
|
47.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 3: ECOG 1 (n=94,48,7,149)
|
44.7 percentage of participants
|
47.9 percentage of participants
|
57.1 percentage of participants
|
46.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 3: ECOG 2 (n=94,48,7,149)
|
5.3 percentage of participants
|
10.4 percentage of participants
|
0.0 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 4: ECOG 0 (n=87,45,7,139)
|
52.9 percentage of participants
|
40.0 percentage of participants
|
28.6 percentage of participants
|
47.5 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 4: ECOG 1 (n=87,45,7,139)
|
43.7 percentage of participants
|
46.7 percentage of participants
|
71.4 percentage of participants
|
46.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 4: ECOG 2 (n=87,45,7,139)
|
3.4 percentage of participants
|
13.3 percentage of participants
|
0.0 percentage of participants
|
6.5 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 5: ECOG 0 (n=88,36,6,130)
|
48.9 percentage of participants
|
36.1 percentage of participants
|
16.7 percentage of participants
|
43.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 5: ECOG 1 (n=88,36,6,130)
|
47.7 percentage of participants
|
52.8 percentage of participants
|
66.7 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 5: ECOG 3 (n=88,36,6,130)
|
1.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 6: ECOG 0 (n=75,36,5,116)
|
50.7 percentage of participants
|
36.1 percentage of participants
|
20.0 percentage of participants
|
44.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 6: ECOG 1 (n=75,36,5,116)
|
45.3 percentage of participants
|
55.6 percentage of participants
|
80.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 7: ECOG 1 (n=67,31,6,104)
|
44.8 percentage of participants
|
45.2 percentage of participants
|
50.0 percentage of participants
|
45.2 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 7: ECOG 2 (n=67,31,6,104)
|
3.0 percentage of participants
|
6.5 percentage of participants
|
16.7 percentage of participants
|
4.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 9: ECOG 0 (n=62,27,4,93)
|
50.0 percentage of participants
|
44.4 percentage of participants
|
25.0 percentage of participants
|
47.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 9: ECOG 2 (n=62,27,4,93)
|
4.8 percentage of participants
|
3.7 percentage of participants
|
25.0 percentage of participants
|
5.4 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 10: ECOG 0 (n=53,29,3,85)
|
56.6 percentage of participants
|
51.7 percentage of participants
|
0.0 percentage of participants
|
52.9 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 10: ECOG 1 (n=53,29,3,85)
|
37.7 percentage of participants
|
41.4 percentage of participants
|
100.0 percentage of participants
|
41.2 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 10: ECOG 2 (n=53,29,3,85)
|
5.7 percentage of participants
|
6.9 percentage of participants
|
0.0 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 11: ECOG 0 (n=54,21,4,79)
|
57.4 percentage of participants
|
42.9 percentage of participants
|
25.0 percentage of participants
|
51.9 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 12: ECOG 0 (n=48,21,3,72)
|
58.3 percentage of participants
|
47.6 percentage of participants
|
0.0 percentage of participants
|
52.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 13: ECOG 0 (n=39,17,1,57)
|
53.8 percentage of participants
|
41.2 percentage of participants
|
0.0 percentage of participants
|
49.1 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 13: ECOG 1 (n=39,17,1,57)
|
41.0 percentage of participants
|
58.8 percentage of participants
|
100.0 percentage of participants
|
47.4 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 13: ECOG 2 (n=39,17,1,57)
|
5.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.5 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 14: ECOG 0 (n=34,15,1,50)
|
50.0 percentage of participants
|
40.0 percentage of participants
|
0.0 percentage of participants
|
46.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 14: ECOG 1 (n=34,15,1,50)
|
47.1 percentage of participants
|
53.3 percentage of participants
|
100.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 15: ECOG 0 (n=30,14,1,45)
|
60.0 percentage of participants
|
42.9 percentage of participants
|
0.0 percentage of participants
|
53.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 15: ECOG 1 (n=30,14,1,45)
|
40.0 percentage of participants
|
57.1 percentage of participants
|
100.0 percentage of participants
|
46.7 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 17: ECOG 0 (n=24,11,1,36)
|
58.3 percentage of participants
|
45.5 percentage of participants
|
0.0 percentage of participants
|
52.8 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 18: ECOG 0 (n=18,9,1,28)
|
50.0 percentage of participants
|
22.2 percentage of participants
|
0.0 percentage of participants
|
39.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 18: ECOG 1 (n=18,9,1,28)
|
50.0 percentage of participants
|
77.8 percentage of participants
|
100.0 percentage of participants
|
60.7 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 19: ECOG 0 (n=19,10,1,30)
|
57.9 percentage of participants
|
30.0 percentage of participants
|
0.0 percentage of participants
|
46.7 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 19: ECOG 1 (n=19,10,1,30)
|
42.1 percentage of participants
|
70.0 percentage of participants
|
100.0 percentage of participants
|
53.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 21: ECOG 0 (n=15,5,0,20)
|
73.3 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
55.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 22: ECOG 1 (n=16,5,0,21)
|
50.0 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
61.9 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 23: ECOG 1 (n=12,5,0,17)
|
50.0 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
64.7 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 24: ECOG 0 (n=10,5,0,15)
|
70.0 percentage of participants
|
20.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
53.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 24: ECOG 2 (n=10,5,0,15)
|
0.0 percentage of participants
|
20.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
6.7 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 25: ECOG 1 (n=9,4,0,13)
|
22.2 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
46.2 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 26: ECOG 0 (n=9,4,0,13)
|
77.8 percentage of participants
|
25.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
61.5 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 27: ECOG 0 (n=8,4,0,12)
|
100.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
66.7 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 27: ECOG 1 (n=8,4,0,12)
|
0.0 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
33.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 28: ECOG 0 (n=5,4,0,9)
|
80.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
44.4 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 30: ECOG 0 (n=6,4,0,10)
|
83.3 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
50.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 30: ECOG 1 (n=6,4,0,10)
|
16.7 percentage of participants
|
75.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
40.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 30: ECOG 2 (n=6,4,0,10)
|
0.0 percentage of participants
|
25.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
10.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 31: ECOG 0 (n=6,3,0,9)
|
83.3 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
55.6 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 31: ECOG 1 (n=6,3,0,9)
|
16.7 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
44.4 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 32: ECOG 1 (n=5,3,0,8)
|
0.0 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
37.5 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 33: ECOG 0 (n=6,3,0,9)
|
100.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
66.7 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 33: ECOG 1 (n=6,3,0,9)
|
0.0 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
33.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 34: ECOG 1 (n=5,3,0,8)
|
0.0 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
37.5 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 34: ECOG 2 (n=5,3,0,8)
|
20.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
12.5 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 35: ECOG 0 (n=5,2,0,7)
|
60.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
42.9 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 35: ECOG 1 (n=5,2,0,7)
|
20.0 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
42.9 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 35: ECOG 2 (n=5,2,0,7)
|
20.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
14.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 36: ECOG 0 (n=5,2,0,7)
|
60.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
42.9 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 36: ECOG 1 (n=5,2,0,7)
|
20.0 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
42.9 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 36: ECOG 2 (n=5,2,0,7)
|
20.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
14.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 37: ECOG 0 (n=5,1,0,6)
|
60.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
50.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 37: ECOG 1 (n=5,1,0,6)
|
20.0 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
33.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 37: ECOG 2 (n=5,1,0,6)
|
20.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
16.7 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 38: ECOG 0 (n=5,1,0,6)
|
60.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
50.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 38: ECOG 1 (n=5,1,0,6)
|
20.0 percentage of participants
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
33.3 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 38: ECOG 2 (n=5,1,0,6)
|
20.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
16.7 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 43: ECOG 0 (n=2,0,0,2)
|
50.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
NA percentage of participants
Data not available as no participant was evaluable.
|
50.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 43: ECOG 2 (n=2,0,0,2)
|
50.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
NA percentage of participants
Data not available as no participant was evaluable.
|
50.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 44: ECOG 0 (n=2,0,0,2)
|
50.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
NA percentage of participants
Data not available as no participant was evaluable.
|
50.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycle 44: ECOG 2 (n=2,0,0,2)
|
50.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
NA percentage of participants
Data not available as no participant was evaluable.
|
50.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycles 45: ECOG 2 (n=1,0,0,1)
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
NA percentage of participants
Data not available as no participant was evaluable.
|
100.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycles 46: ECOG 2 (n=1,0,0,1)
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
NA percentage of participants
Data not available as no participant was evaluable.
|
100.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycles 47: ECOG 2 (n=1,0,0,1)
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
NA percentage of participants
Data not available as no participant was evaluable.
|
100.0 percentage of participants
|
|
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Cycles 51: ECOG 1 (n=1,0,0,1)
|
100.0 percentage of participants
|
NA percentage of participants
Data not available as no participant was evaluable.
|
NA percentage of participants
Data not available as no participant was evaluable.
|
100.0 percentage of participants
|
Adverse Events
Bevacizumab: Overall
Serious events: 94 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab: Overall
n=201 participants at risk
All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.5%
7/201 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
4/201 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
3/201 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.50%
1/201 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.00%
2/201 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.50%
1/201 • Up to approximately 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
1.00%
2/201 • Up to approximately 3 years
|
|
Cardiac disorders
Myocardial infarction
|
1.00%
2/201 • Up to approximately 3 years
|
|
Cardiac disorders
Bradycardia
|
0.50%
1/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
15/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.50%
1/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.50%
1/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
5/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Nausea
|
2.0%
4/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
5/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Enteritis
|
0.50%
1/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.50%
1/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Enterocolitis
|
1.00%
2/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.50%
1/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.00%
2/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.50%
1/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Ascites
|
0.50%
1/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Anal fistula
|
0.50%
1/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Dyschezia
|
0.50%
1/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.50%
1/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Anal Fissure
|
0.50%
1/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.50%
1/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.50%
1/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Faecalith
|
0.50%
1/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.50%
1/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Colitis
|
0.50%
1/201 • Up to approximately 3 years
|
|
General disorders
Pyrexia
|
5.0%
10/201 • Up to approximately 3 years
|
|
General disorders
Inflammation
|
0.50%
1/201 • Up to approximately 3 years
|
|
General disorders
Pain
|
1.00%
2/201 • Up to approximately 3 years
|
|
General disorders
Disease progression
|
1.5%
3/201 • Up to approximately 3 years
|
|
General disorders
Fatigue
|
1.00%
2/201 • Up to approximately 3 years
|
|
General disorders
Asthenia
|
1.5%
3/201 • Up to approximately 3 years
|
|
General disorders
Mucosal inflammation
|
2.0%
4/201 • Up to approximately 3 years
|
|
General disorders
General physical health deterioration
|
3.0%
6/201 • Up to approximately 3 years
|
|
General disorders
Chest pain
|
0.50%
1/201 • Up to approximately 3 years
|
|
General disorders
Unevaluable event
|
0.50%
1/201 • Up to approximately 3 years
|
|
General disorders
Ulcer
|
0.50%
1/201 • Up to approximately 3 years
|
|
Hepatobiliary disorders
Bile duct stone
|
1.00%
2/201 • Up to approximately 3 years
|
|
Hepatobiliary disorders
Cholangitis
|
1.00%
2/201 • Up to approximately 3 years
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.50%
1/201 • Up to approximately 3 years
|
|
Immune system disorders
Hypersensitivity
|
0.50%
1/201 • Up to approximately 3 years
|
|
Infections and infestations
Urinary tract infection
|
0.50%
1/201 • Up to approximately 3 years
|
|
Infections and infestations
Bacterial prostatitis
|
0.50%
1/201 • Up to approximately 3 years
|
|
Infections and infestations
Intervertebral discitis
|
0.50%
1/201 • Up to approximately 3 years
|
|
Infections and infestations
Gastrointestinal infection
|
0.50%
1/201 • Up to approximately 3 years
|
|
Infections and infestations
Lung infection
|
2.5%
5/201 • Up to approximately 3 years
|
|
Infections and infestations
Pneumonia
|
1.5%
3/201 • Up to approximately 3 years
|
|
Infections and infestations
Anal abscess
|
1.5%
3/201 • Up to approximately 3 years
|
|
Infections and infestations
Conjunctivitis
|
1.5%
3/201 • Up to approximately 3 years
|
|
Infections and infestations
Colonic abscess
|
0.50%
1/201 • Up to approximately 3 years
|
|
Infections and infestations
Gastroenteritis
|
0.50%
1/201 • Up to approximately 3 years
|
|
Infections and infestations
Herpes zoster
|
0.50%
1/201 • Up to approximately 3 years
|
|
Infections and infestations
Spinal cord infection
|
0.50%
1/201 • Up to approximately 3 years
|
|
Infections and infestations
Escherichia sepsis
|
0.50%
1/201 • Up to approximately 3 years
|
|
Infections and infestations
Abscess
|
0.50%
1/201 • Up to approximately 3 years
|
|
Infections and infestations
Septic shock
|
0.50%
1/201 • Up to approximately 3 years
|
|
Infections and infestations
Bronchitis
|
0.50%
1/201 • Up to approximately 3 years
|
|
Infections and infestations
Diverticulitis
|
0.50%
1/201 • Up to approximately 3 years
|
|
Infections and infestations
Pelvic abscess
|
0.50%
1/201 • Up to approximately 3 years
|
|
Infections and infestations
Sepsis
|
0.50%
1/201 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.50%
1/201 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.50%
1/201 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.50%
1/201 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.50%
1/201 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.50%
1/201 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.50%
1/201 • Up to approximately 3 years
|
|
Investigations
Weight decreased
|
0.50%
1/201 • Up to approximately 3 years
|
|
Investigations
Blood bilirubin increased
|
0.50%
1/201 • Up to approximately 3 years
|
|
Investigations
General physical condition abnormal
|
0.50%
1/201 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.5%
9/201 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
3/201 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.50%
1/201 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.50%
1/201 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.00%
2/201 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.50%
1/201 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.50%
1/201 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.50%
1/201 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.50%
1/201 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.00%
2/201 • Up to approximately 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.50%
1/201 • Up to approximately 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.50%
1/201 • Up to approximately 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.50%
1/201 • Up to approximately 3 years
|
|
Nervous system disorders
Epilepsy
|
0.50%
1/201 • Up to approximately 3 years
|
|
Nervous system disorders
Cerebral ischaemia
|
0.50%
1/201 • Up to approximately 3 years
|
|
Nervous system disorders
Neurotoxicity
|
0.50%
1/201 • Up to approximately 3 years
|
|
Nervous system disorders
Polyneuropathy
|
0.50%
1/201 • Up to approximately 3 years
|
|
Nervous system disorders
Peripheral paralysis
|
0.50%
1/201 • Up to approximately 3 years
|
|
Psychiatric disorders
Confusional state
|
0.50%
1/201 • Up to approximately 3 years
|
|
Renal and urinary disorders
Renal failure
|
1.00%
2/201 • Up to approximately 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.50%
1/201 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.50%
1/201 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.00%
2/201 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.50%
1/201 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
1.00%
2/201 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
1/201 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.50%
1/201 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.00%
2/201 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.50%
1/201 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.50%
1/201 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.50%
1/201 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.50%
1/201 • Up to approximately 3 years
|
|
Surgical and medical procedures
Cancer surgery
|
1.00%
2/201 • Up to approximately 3 years
|
|
Surgical and medical procedures
Hepatectomy
|
0.50%
1/201 • Up to approximately 3 years
|
|
Vascular disorders
Deep vein thrombosis
|
1.00%
2/201 • Up to approximately 3 years
|
|
Vascular disorders
Venous thrombosis
|
0.50%
1/201 • Up to approximately 3 years
|
|
Vascular disorders
Jugular vein thrombosis
|
0.50%
1/201 • Up to approximately 3 years
|
|
Vascular disorders
Hypertensive crisis
|
0.50%
1/201 • Up to approximately 3 years
|
|
Vascular disorders
Thrombosis
|
0.50%
1/201 • Up to approximately 3 years
|
|
Vascular disorders
Haemorrhage
|
0.50%
1/201 • Up to approximately 3 years
|
Other adverse events
| Measure |
Bevacizumab: Overall
n=201 participants at risk
All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
7.0%
14/201 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Anaemia
|
5.5%
11/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
31/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
5.5%
11/201 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Stomatitis
|
6.0%
12/201 • Up to approximately 3 years
|
|
General disorders
Fatigue
|
10.9%
22/201 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.0%
10/201 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
20/201 • Up to approximately 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER