Trial Outcomes & Findings for 2-arm Trial of Paclitaxel Plus Bevacizumab vs. Capecitabine Plus Bevacizumab (NCT NCT00600340)
NCT ID: NCT00600340
Last Updated: 2019-12-30
Results Overview
Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 47% of information was 0.0010. Alpha spent at final analysis after 99% of information was 0.0250.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
564 participants
Primary outcome timeframe
Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years
Results posted on
2019-12-30
Participant Flow
Participant milestones
| Measure |
Bevacizumab Plus Paclitaxel
Bevacizumab 10 mg/kg i.v., days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine twice-daily 1000 mg/m², day 1 to 14, every 3 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
285
|
279
|
|
Overall Study
COMPLETED
|
285
|
279
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only participants with neoadjuvant/adjuvant hormonal therapy included. Multiple answers per patient possible.
Baseline characteristics by cohort
| Measure |
Bevacizumab Plus Paclitaxel
n=285 Participants
Bevacizumab 10 mg/kg i.v., days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=279 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine twice-daily 1000 mg/m², day 1 to 14, every 3 weeks
|
Total
n=564 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=285 Participants
|
0 Participants
n=279 Participants
|
0 Participants
n=564 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
218 Participants
n=285 Participants
|
201 Participants
n=279 Participants
|
419 Participants
n=564 Participants
|
|
Age, Categorical
>=65 years
|
67 Participants
n=285 Participants
|
78 Participants
n=279 Participants
|
145 Participants
n=564 Participants
|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 10.98 • n=285 Participants
|
56.6 years
STANDARD_DEVIATION 11.67 • n=279 Participants
|
56.6 years
STANDARD_DEVIATION 11.32 • n=564 Participants
|
|
Sex: Female, Male
Female
|
284 Participants
n=285 Participants
|
275 Participants
n=279 Participants
|
559 Participants
n=564 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=285 Participants
|
4 Participants
n=279 Participants
|
5 Participants
n=564 Participants
|
|
Race/Ethnicity, Customized
Caucasian/ White
|
283 Participants
n=285 Participants
|
278 Participants
n=279 Participants
|
561 Participants
n=564 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=285 Participants
|
0 Participants
n=279 Participants
|
1 Participants
n=564 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=285 Participants
|
1 Participants
n=279 Participants
|
2 Participants
n=564 Participants
|
|
Region of Enrollment
Austria
|
38 participants
n=285 Participants
|
37 participants
n=279 Participants
|
75 participants
n=564 Participants
|
|
Region of Enrollment
Latvia
|
15 participants
n=285 Participants
|
12 participants
n=279 Participants
|
27 participants
n=564 Participants
|
|
Region of Enrollment
Romania
|
20 participants
n=285 Participants
|
22 participants
n=279 Participants
|
42 participants
n=564 Participants
|
|
Region of Enrollment
Hungary
|
82 participants
n=285 Participants
|
80 participants
n=279 Participants
|
162 participants
n=564 Participants
|
|
Region of Enrollment
Czechia
|
18 participants
n=285 Participants
|
19 participants
n=279 Participants
|
37 participants
n=564 Participants
|
|
Region of Enrollment
Poland
|
19 participants
n=285 Participants
|
17 participants
n=279 Participants
|
36 participants
n=564 Participants
|
|
Region of Enrollment
Slovakia
|
6 participants
n=285 Participants
|
9 participants
n=279 Participants
|
15 participants
n=564 Participants
|
|
Region of Enrollment
Israel
|
54 participants
n=285 Participants
|
51 participants
n=279 Participants
|
105 participants
n=564 Participants
|
|
Region of Enrollment
Bulgaria
|
7 participants
n=285 Participants
|
6 participants
n=279 Participants
|
13 participants
n=564 Participants
|
|
Region of Enrollment
Serbia
|
6 participants
n=285 Participants
|
8 participants
n=279 Participants
|
14 participants
n=564 Participants
|
|
Region of Enrollment
Bosnia and Herzegovina
|
13 participants
n=285 Participants
|
13 participants
n=279 Participants
|
26 participants
n=564 Participants
|
|
Region of Enrollment
Croatia
|
7 participants
n=285 Participants
|
5 participants
n=279 Participants
|
12 participants
n=564 Participants
|
|
Menopausal status
Pre-menopausal
|
52 Participants
n=285 Participants
|
52 Participants
n=279 Participants
|
104 Participants
n=564 Participants
|
|
Menopausal status
Post-menopausal
|
232 Participants
n=285 Participants
|
223 Participants
n=279 Participants
|
455 Participants
n=564 Participants
|
|
Menopausal status
Male patients
|
1 Participants
n=285 Participants
|
4 Participants
n=279 Participants
|
5 Participants
n=564 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
0
|
193 Participants
n=285 Participants
|
179 Participants
n=279 Participants
|
372 Participants
n=564 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
1
|
75 Participants
n=285 Participants
|
91 Participants
n=279 Participants
|
166 Participants
n=564 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
2
|
16 Participants
n=285 Participants
|
7 Participants
n=279 Participants
|
23 Participants
n=564 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Missing
|
1 Participants
n=285 Participants
|
2 Participants
n=279 Participants
|
3 Participants
n=564 Participants
|
|
Estrogen receptor (ER)
Positive
|
215 Participants
n=285 Participants
|
201 Participants
n=279 Participants
|
416 Participants
n=564 Participants
|
|
Estrogen receptor (ER)
Negative
|
68 Participants
n=285 Participants
|
77 Participants
n=279 Participants
|
145 Participants
n=564 Participants
|
|
Estrogen receptor (ER)
Unknown
|
2 Participants
n=285 Participants
|
1 Participants
n=279 Participants
|
3 Participants
n=564 Participants
|
|
Progesterone Receptor (PgR)
Positive
|
167 Participants
n=285 Participants
|
168 Participants
n=279 Participants
|
335 Participants
n=564 Participants
|
|
Progesterone Receptor (PgR)
Negative
|
118 Participants
n=285 Participants
|
109 Participants
n=279 Participants
|
227 Participants
n=564 Participants
|
|
Progesterone Receptor (PgR)
Unknown
|
0 Participants
n=285 Participants
|
2 Participants
n=279 Participants
|
2 Participants
n=564 Participants
|
|
Estrogen and progesterone receptor
ER and PgR negative
|
63 Participants
n=285 Participants
|
67 Participants
n=279 Participants
|
130 Participants
n=564 Participants
|
|
Estrogen and progesterone receptor
ER or PgR positive
|
221 Participants
n=285 Participants
|
212 Participants
n=279 Participants
|
433 Participants
n=564 Participants
|
|
Estrogen and progesterone receptor
ER and PR unknown or negative
|
1 Participants
n=285 Participants
|
0 Participants
n=279 Participants
|
1 Participants
n=564 Participants
|
|
Electrocardiogram (ECG) result
Normal
|
243 Participants
n=285 Participants
|
246 Participants
n=279 Participants
|
489 Participants
n=564 Participants
|
|
Electrocardiogram (ECG) result
Abnormal
|
39 Participants
n=285 Participants
|
30 Participants
n=279 Participants
|
69 Participants
n=564 Participants
|
|
Electrocardiogram (ECG) result
Not performed
|
3 Participants
n=285 Participants
|
3 Participants
n=279 Participants
|
6 Participants
n=564 Participants
|
|
Method for brain imaging
CT
|
18 Participants
n=285 Participants
|
19 Participants
n=279 Participants
|
37 Participants
n=564 Participants
|
|
Method for brain imaging
MRI
|
3 Participants
n=285 Participants
|
2 Participants
n=279 Participants
|
5 Participants
n=564 Participants
|
|
Method for brain imaging
No brain CT/MRI
|
264 Participants
n=285 Participants
|
258 Participants
n=279 Participants
|
522 Participants
n=564 Participants
|
|
Result of brain CT/MRI
No metastasis
|
21 Participants
n=285 Participants
|
21 Participants
n=279 Participants
|
42 Participants
n=564 Participants
|
|
Result of brain CT/MRI
No brain CT/MRI
|
264 Participants
n=285 Participants
|
258 Participants
n=279 Participants
|
522 Participants
n=564 Participants
|
|
Stage at primary diagnosis: Primary tumor (T)
Tis
|
1 Participants
n=285 Participants
|
2 Participants
n=279 Participants
|
3 Participants
n=564 Participants
|
|
Stage at primary diagnosis: Primary tumor (T)
T1
|
66 Participants
n=285 Participants
|
72 Participants
n=279 Participants
|
138 Participants
n=564 Participants
|
|
Stage at primary diagnosis: Primary tumor (T)
T2
|
130 Participants
n=285 Participants
|
118 Participants
n=279 Participants
|
248 Participants
n=564 Participants
|
|
Stage at primary diagnosis: Primary tumor (T)
T3
|
26 Participants
n=285 Participants
|
32 Participants
n=279 Participants
|
58 Participants
n=564 Participants
|
|
Stage at primary diagnosis: Primary tumor (T)
T4
|
45 Participants
n=285 Participants
|
38 Participants
n=279 Participants
|
83 Participants
n=564 Participants
|
|
Stage at primary diagnosis: Primary tumor (T)
TX
|
16 Participants
n=285 Participants
|
16 Participants
n=279 Participants
|
32 Participants
n=564 Participants
|
|
Stage at primary diagnosis: Primary tumor (T)
Missing
|
1 Participants
n=285 Participants
|
1 Participants
n=279 Participants
|
2 Participants
n=564 Participants
|
|
Stage at primary diagnosis: Regional lymph nodes (N)
N0
|
78 Participants
n=285 Participants
|
62 Participants
n=279 Participants
|
140 Participants
n=564 Participants
|
|
Stage at primary diagnosis: Regional lymph nodes (N)
N1
|
97 Participants
n=285 Participants
|
116 Participants
n=279 Participants
|
213 Participants
n=564 Participants
|
|
Stage at primary diagnosis: Regional lymph nodes (N)
N2
|
55 Participants
n=285 Participants
|
51 Participants
n=279 Participants
|
106 Participants
n=564 Participants
|
|
Stage at primary diagnosis: Regional lymph nodes (N)
N3
|
26 Participants
n=285 Participants
|
22 Participants
n=279 Participants
|
48 Participants
n=564 Participants
|
|
Stage at primary diagnosis: Regional lymph nodes (N)
NX
|
28 Participants
n=285 Participants
|
27 Participants
n=279 Participants
|
55 Participants
n=564 Participants
|
|
Stage at primary diagnosis: Regional lymph nodes (N)
Missing
|
1 Participants
n=285 Participants
|
1 Participants
n=279 Participants
|
2 Participants
n=564 Participants
|
|
Stage at primary diagnosis: Distant metastasis (M)
M0
|
222 Participants
n=285 Participants
|
219 Participants
n=279 Participants
|
441 Participants
n=564 Participants
|
|
Stage at primary diagnosis: Distant metastasis (M)
M1
|
62 Participants
n=285 Participants
|
59 Participants
n=279 Participants
|
121 Participants
n=564 Participants
|
|
Stage at primary diagnosis: Distant metastasis (M)
Missing
|
1 Participants
n=285 Participants
|
1 Participants
n=279 Participants
|
2 Participants
n=564 Participants
|
|
Current stage of locally recurrent/ metastatic tumor
Locally recurrent breast cancer
|
2 Participants
n=285 Participants
|
0 Participants
n=279 Participants
|
2 Participants
n=564 Participants
|
|
Current stage of locally recurrent/ metastatic tumor
Metastatic breast cancer
|
282 Participants
n=285 Participants
|
279 Participants
n=279 Participants
|
561 Participants
n=564 Participants
|
|
Current stage of locally recurrent/ metastatic tumor
Missing
|
1 Participants
n=285 Participants
|
0 Participants
n=279 Participants
|
1 Participants
n=564 Participants
|
|
Disease free interval after therapy of primary breast cancer
Yes
|
214 Participants
n=285 Participants
|
215 Participants
n=279 Participants
|
429 Participants
n=564 Participants
|
|
Disease free interval after therapy of primary breast cancer
No
|
71 Participants
n=285 Participants
|
64 Participants
n=279 Participants
|
135 Participants
n=564 Participants
|
|
Disease free interval
No DFI
|
71 Participants
n=285 Participants
|
64 Participants
n=279 Participants
|
135 Participants
n=564 Participants
|
|
Disease free interval
DFI <=12 months
|
14 Participants
n=285 Participants
|
10 Participants
n=279 Participants
|
24 Participants
n=564 Participants
|
|
Disease free interval
DFI >12 and <=24 months
|
52 Participants
n=285 Participants
|
34 Participants
n=279 Participants
|
86 Participants
n=564 Participants
|
|
Disease free interval
DFI >24 months
|
148 Participants
n=285 Participants
|
171 Participants
n=279 Participants
|
319 Participants
n=564 Participants
|
|
Metastatic lesions
At least one metastatic lesion
|
282 Participants
n=285 Participants
|
279 Participants
n=279 Participants
|
561 Participants
n=564 Participants
|
|
Metastatic lesions
Bone
|
158 Participants
n=285 Participants
|
151 Participants
n=279 Participants
|
309 Participants
n=564 Participants
|
|
Metastatic lesions
Lung
|
112 Participants
n=285 Participants
|
122 Participants
n=279 Participants
|
234 Participants
n=564 Participants
|
|
Metastatic lesions
Liver
|
113 Participants
n=285 Participants
|
126 Participants
n=279 Participants
|
239 Participants
n=564 Participants
|
|
Metastatic lesions
Skin
|
13 Participants
n=285 Participants
|
9 Participants
n=279 Participants
|
22 Participants
n=564 Participants
|
|
Metastatic lesions
Soft tissue
|
69 Participants
n=285 Participants
|
63 Participants
n=279 Participants
|
132 Participants
n=564 Participants
|
|
Metastatic lesions
Lymph nodes
|
146 Participants
n=285 Participants
|
171 Participants
n=279 Participants
|
317 Participants
n=564 Participants
|
|
Metastatic lesions
Other
|
19 Participants
n=285 Participants
|
25 Participants
n=279 Participants
|
44 Participants
n=564 Participants
|
|
Metastatic lesions
Lung and / or liver
|
185 Participants
n=285 Participants
|
203 Participants
n=279 Participants
|
388 Participants
n=564 Participants
|
|
Metastatic lesions
Soft tissue and/or bone only
|
41 Participants
n=285 Participants
|
23 Participants
n=279 Participants
|
64 Participants
n=564 Participants
|
|
Imaging methods
CT
|
270 Participants
n=285 Participants
|
261 Participants
n=279 Participants
|
531 Participants
n=564 Participants
|
|
Imaging methods
MRI
|
8 Participants
n=285 Participants
|
12 Participants
n=279 Participants
|
20 Participants
n=564 Participants
|
|
Imaging methods
X-ray
|
7 Participants
n=285 Participants
|
6 Participants
n=279 Participants
|
13 Participants
n=564 Participants
|
|
Target and non-target lesions
Target lesions only
|
34 Participants
n=285 Participants
|
22 Participants
n=279 Participants
|
56 Participants
n=564 Participants
|
|
Target and non-target lesions
Non-target lesions only
|
65 Participants
n=285 Participants
|
49 Participants
n=279 Participants
|
114 Participants
n=564 Participants
|
|
Target and non-target lesions
Both
|
185 Participants
n=285 Participants
|
208 Participants
n=279 Participants
|
393 Participants
n=564 Participants
|
|
Target and non-target lesions
None
|
1 Participants
n=285 Participants
|
0 Participants
n=279 Participants
|
1 Participants
n=564 Participants
|
|
Number of target lesions
0 lesions
|
66 Participants
n=285 Participants
|
49 Participants
n=279 Participants
|
115 Participants
n=564 Participants
|
|
Number of target lesions
1 lesions
|
48 Participants
n=285 Participants
|
49 Participants
n=279 Participants
|
97 Participants
n=564 Participants
|
|
Number of target lesions
2 lesions
|
41 Participants
n=285 Participants
|
49 Participants
n=279 Participants
|
90 Participants
n=564 Participants
|
|
Number of target lesions
3 lesions
|
47 Participants
n=285 Participants
|
39 Participants
n=279 Participants
|
86 Participants
n=564 Participants
|
|
Number of target lesions
4-5 lesions
|
44 Participants
n=285 Participants
|
57 Participants
n=279 Participants
|
101 Participants
n=564 Participants
|
|
Number of target lesions
>= 6 lesions
|
39 Participants
n=285 Participants
|
36 Participants
n=279 Participants
|
75 Participants
n=564 Participants
|
|
Sum of longest diameter of target lesion
No lesions
|
66 Participants
n=285 Participants
|
49 Participants
n=279 Participants
|
115 Participants
n=564 Participants
|
|
Sum of longest diameter of target lesion
1-5 cm
|
86 Participants
n=285 Participants
|
83 Participants
n=279 Participants
|
169 Participants
n=564 Participants
|
|
Sum of longest diameter of target lesion
>5-10 cm
|
64 Participants
n=285 Participants
|
77 Participants
n=279 Participants
|
141 Participants
n=564 Participants
|
|
Sum of longest diameter of target lesion
>10 cm
|
69 Participants
n=285 Participants
|
70 Participants
n=279 Participants
|
139 Participants
n=564 Participants
|
|
Number of organs with metastases
>= 3
|
105 Participants
n=285 Participants
|
124 Participants
n=279 Participants
|
229 Participants
n=564 Participants
|
|
Number of organs with metastases
< 3
|
180 Participants
n=285 Participants
|
155 Participants
n=279 Participants
|
335 Participants
n=564 Participants
|
|
Previous hormonal therapy
Neoadjuvant/adjuvant only
|
113 Participants
n=285 Participants
|
112 Participants
n=279 Participants
|
225 Participants
n=564 Participants
|
|
Previous hormonal therapy
LR/MBC only
|
25 Participants
n=285 Participants
|
33 Participants
n=279 Participants
|
58 Participants
n=564 Participants
|
|
Previous hormonal therapy
Both
|
37 Participants
n=285 Participants
|
25 Participants
n=279 Participants
|
62 Participants
n=564 Participants
|
|
Previous hormonal therapy
Other
|
0 Participants
n=285 Participants
|
1 Participants
n=279 Participants
|
1 Participants
n=564 Participants
|
|
Previous hormonal therapy
None
|
110 Participants
n=285 Participants
|
108 Participants
n=279 Participants
|
218 Participants
n=564 Participants
|
|
Neoadjuvant/ adjuvant hormonal therapy only
Anti-estrogens
|
87 Participants
n=113 Participants • Only participants with neoadjuvant/adjuvant hormonal therapy included. Multiple answers per patient possible.
|
89 Participants
n=112 Participants • Only participants with neoadjuvant/adjuvant hormonal therapy included. Multiple answers per patient possible.
|
176 Participants
n=225 Participants • Only participants with neoadjuvant/adjuvant hormonal therapy included. Multiple answers per patient possible.
|
|
Neoadjuvant/ adjuvant hormonal therapy only
Aromatase inhibitors
|
56 Participants
n=113 Participants • Only participants with neoadjuvant/adjuvant hormonal therapy included. Multiple answers per patient possible.
|
56 Participants
n=112 Participants • Only participants with neoadjuvant/adjuvant hormonal therapy included. Multiple answers per patient possible.
|
112 Participants
n=225 Participants • Only participants with neoadjuvant/adjuvant hormonal therapy included. Multiple answers per patient possible.
|
|
Neoadjuvant/ adjuvant hormonal therapy only
LR-RH analogues
|
12 Participants
n=113 Participants • Only participants with neoadjuvant/adjuvant hormonal therapy included. Multiple answers per patient possible.
|
15 Participants
n=112 Participants • Only participants with neoadjuvant/adjuvant hormonal therapy included. Multiple answers per patient possible.
|
27 Participants
n=225 Participants • Only participants with neoadjuvant/adjuvant hormonal therapy included. Multiple answers per patient possible.
|
|
Neoadjuvant/ adjuvant hormonal therapy only
Progesterone
|
0 Participants
n=113 Participants • Only participants with neoadjuvant/adjuvant hormonal therapy included. Multiple answers per patient possible.
|
1 Participants
n=112 Participants • Only participants with neoadjuvant/adjuvant hormonal therapy included. Multiple answers per patient possible.
|
1 Participants
n=225 Participants • Only participants with neoadjuvant/adjuvant hormonal therapy included. Multiple answers per patient possible.
|
|
Neoadjuvant/ adjuvant hormonal therapy only
Other
|
0 Participants
n=113 Participants • Only participants with neoadjuvant/adjuvant hormonal therapy included. Multiple answers per patient possible.
|
1 Participants
n=112 Participants • Only participants with neoadjuvant/adjuvant hormonal therapy included. Multiple answers per patient possible.
|
1 Participants
n=225 Participants • Only participants with neoadjuvant/adjuvant hormonal therapy included. Multiple answers per patient possible.
|
|
Hormonal therapy for LR/MBC only
Anti-estrogens
|
18 Participants
n=25 Participants • Only participants with hormonal therapy for LR/ MBC included. Multiple answers per patient possible.
|
29 Participants
n=33 Participants • Only participants with hormonal therapy for LR/ MBC included. Multiple answers per patient possible.
|
47 Participants
n=58 Participants • Only participants with hormonal therapy for LR/ MBC included. Multiple answers per patient possible.
|
|
Hormonal therapy for LR/MBC only
Aromatase inhibitors
|
17 Participants
n=25 Participants • Only participants with hormonal therapy for LR/ MBC included. Multiple answers per patient possible.
|
23 Participants
n=33 Participants • Only participants with hormonal therapy for LR/ MBC included. Multiple answers per patient possible.
|
40 Participants
n=58 Participants • Only participants with hormonal therapy for LR/ MBC included. Multiple answers per patient possible.
|
|
Hormonal therapy for LR/MBC only
LH-RH analogues
|
1 Participants
n=25 Participants • Only participants with hormonal therapy for LR/ MBC included. Multiple answers per patient possible.
|
4 Participants
n=33 Participants • Only participants with hormonal therapy for LR/ MBC included. Multiple answers per patient possible.
|
5 Participants
n=58 Participants • Only participants with hormonal therapy for LR/ MBC included. Multiple answers per patient possible.
|
|
Previous neoadjuvant chemotherapy
Anthracycline and taxane
|
16 Participants
n=285 Participants
|
11 Participants
n=279 Participants
|
27 Participants
n=564 Participants
|
|
Previous neoadjuvant chemotherapy
Anthracycline, no taxane
|
41 Participants
n=285 Participants
|
33 Participants
n=279 Participants
|
74 Participants
n=564 Participants
|
|
Previous neoadjuvant chemotherapy
Taxane, no anthracycline
|
5 Participants
n=285 Participants
|
5 Participants
n=279 Participants
|
10 Participants
n=564 Participants
|
|
Previous neoadjuvant chemotherapy
No anthracycline, no taxane, other
|
2 Participants
n=285 Participants
|
3 Participants
n=279 Participants
|
5 Participants
n=564 Participants
|
|
Previous neoadjuvant chemotherapy
None
|
221 Participants
n=285 Participants
|
227 Participants
n=279 Participants
|
448 Participants
n=564 Participants
|
|
Previous adjuvant chemotherapy
Anthracycline and taxane
|
21 Participants
n=285 Participants
|
25 Participants
n=279 Participants
|
46 Participants
n=564 Participants
|
|
Previous adjuvant chemotherapy
Anthracycline, no taxane
|
83 Participants
n=285 Participants
|
89 Participants
n=279 Participants
|
172 Participants
n=564 Participants
|
|
Previous adjuvant chemotherapy
Taxane, no anthracycline
|
16 Participants
n=285 Participants
|
12 Participants
n=279 Participants
|
28 Participants
n=564 Participants
|
|
Previous adjuvant chemotherapy
No anthracycline, no taxane, other
|
30 Participants
n=285 Participants
|
25 Participants
n=279 Participants
|
55 Participants
n=564 Participants
|
|
Previous adjuvant chemotherapy
None
|
135 Participants
n=285 Participants
|
128 Participants
n=279 Participants
|
263 Participants
n=564 Participants
|
|
Previous neoadjuvant/adjuvant chemotherapy
Anthracycline and taxane
|
37 Participants
n=285 Participants
|
35 Participants
n=279 Participants
|
72 Participants
n=564 Participants
|
|
Previous neoadjuvant/adjuvant chemotherapy
Anthracycline, no taxane
|
110 Participants
n=285 Participants
|
112 Participants
n=279 Participants
|
222 Participants
n=564 Participants
|
|
Previous neoadjuvant/adjuvant chemotherapy
Taxane, no anthracycline
|
21 Participants
n=285 Participants
|
16 Participants
n=279 Participants
|
37 Participants
n=564 Participants
|
|
Previous neoadjuvant/adjuvant chemotherapy
No anthracycline, no taxane, other
|
32 Participants
n=285 Participants
|
28 Participants
n=279 Participants
|
60 Participants
n=564 Participants
|
|
Previous neoadjuvant/adjuvant chemotherapy
None
|
105 Participants
n=285 Participants
|
103 Participants
n=279 Participants
|
208 Participants
n=564 Participants
|
|
Previous neoadjuvant/adjuvant chemotherapy medications
Anthracycline
|
145 Participants
n=285 Participants
|
144 Participants
n=279 Participants
|
289 Participants
n=564 Participants
|
|
Previous neoadjuvant/adjuvant chemotherapy medications
Taxane
|
57 Participants
n=285 Participants
|
50 Participants
n=279 Participants
|
107 Participants
n=564 Participants
|
|
Previous neoadjuvant/adjuvant chemotherapy medications
No anthracycline, no taxane, other
|
26 Participants
n=285 Participants
|
26 Participants
n=279 Participants
|
52 Participants
n=564 Participants
|
|
Previous neoadjuvant/adjuvant chemotherapy medications
None
|
105 Participants
n=285 Participants
|
103 Participants
n=279 Participants
|
208 Participants
n=564 Participants
|
|
Previous radiotherapy
Neoadjuvant
|
8 Participants
n=191 Participants • Restricted to patients with previous radiotherapy.
|
9 Participants
n=194 Participants • Restricted to patients with previous radiotherapy.
|
17 Participants
n=385 Participants • Restricted to patients with previous radiotherapy.
|
|
Previous radiotherapy
Adjuvant
|
167 Participants
n=191 Participants • Restricted to patients with previous radiotherapy.
|
171 Participants
n=194 Participants • Restricted to patients with previous radiotherapy.
|
338 Participants
n=385 Participants • Restricted to patients with previous radiotherapy.
|
|
Previous radiotherapy
For relief of metastatic bone pain
|
32 Participants
n=191 Participants • Restricted to patients with previous radiotherapy.
|
44 Participants
n=194 Participants • Restricted to patients with previous radiotherapy.
|
76 Participants
n=385 Participants • Restricted to patients with previous radiotherapy.
|
|
Previous surgery
Total mastectomy
|
131 Participants
n=241 Participants • Restricted to patients with previous surgery.
|
135 Participants
n=239 Participants • Restricted to patients with previous surgery.
|
266 Participants
n=480 Participants • Restricted to patients with previous surgery.
|
|
Previous surgery
Breast conserving surgery
|
111 Participants
n=241 Participants • Restricted to patients with previous surgery.
|
99 Participants
n=239 Participants • Restricted to patients with previous surgery.
|
210 Participants
n=480 Participants • Restricted to patients with previous surgery.
|
|
Previous surgery
Biopsy/Aspiration
|
54 Participants
n=241 Participants • Restricted to patients with previous surgery.
|
48 Participants
n=239 Participants • Restricted to patients with previous surgery.
|
102 Participants
n=480 Participants • Restricted to patients with previous surgery.
|
|
Previous surgery
Other
|
35 Participants
n=241 Participants • Restricted to patients with previous surgery.
|
29 Participants
n=239 Participants • Restricted to patients with previous surgery.
|
64 Participants
n=480 Participants • Restricted to patients with previous surgery.
|
|
Height
|
162 cm
STANDARD_DEVIATION 6.60 • n=285 Participants
|
162.3 cm
STANDARD_DEVIATION 6.48 • n=279 Participants
|
162.2 cm
STANDARD_DEVIATION 6.54 • n=564 Participants
|
|
Body Surface Area (BSA)
|
1.76 m²
STANDARD_DEVIATION 0.1834 • n=285 Participants
|
1.773 m²
STANDARD_DEVIATION 0.1688 • n=279 Participants
|
1.767 m²
STANDARD_DEVIATION 0.1763 • n=564 Participants
|
|
Systolic blood pressure
|
127.9 mmHg
STANDARD_DEVIATION 12.91 • n=285 Participants
|
128.7 mmHg
STANDARD_DEVIATION 13.85 • n=279 Participants
|
128.3 mmHg
STANDARD_DEVIATION 13.38 • n=564 Participants
|
|
Diastolic blood pressure
|
78.1 mmHg
STANDARD_DEVIATION 8.23 • n=285 Participants
|
77.9 mmHg
STANDARD_DEVIATION 9.34 • n=279 Participants
|
78.0 mmHg
STANDARD_DEVIATION 8.79 • n=564 Participants
|
|
Heart rate
|
79.7 bpm
STANDARD_DEVIATION 11.27 • n=285 Participants
|
79.1 bpm
STANDARD_DEVIATION 11.41 • n=279 Participants
|
79.4 bpm
STANDARD_DEVIATION 11.33 • n=564 Participants
|
|
Body temperature
|
36.55 °C
STANDARD_DEVIATION 0.265 • n=285 Participants
|
36.47 °C
STANDARD_DEVIATION 0.305 • n=279 Participants
|
36.51 °C
STANDARD_DEVIATION 0.288 • n=564 Participants
|
|
Left Ventricular Ejection Fraction (LVEF)
|
63.4 percentage of ejected blood
STANDARD_DEVIATION 5.32 • n=285 Participants
|
62.6 percentage of ejected blood
STANDARD_DEVIATION 6.26 • n=279 Participants
|
63.0 percentage of ejected blood
STANDARD_DEVIATION 5.81 • n=564 Participants
|
|
Time since diagnosis of adenocarcinoma
|
55.2 months
STANDARD_DEVIATION 56.46 • n=285 Participants
|
58.9 months
STANDARD_DEVIATION 55.09 • n=279 Participants
|
57.0 months
STANDARD_DEVIATION 55.77 • n=564 Participants
|
|
Time since diagnosis of LR or MT
|
5.7 months
STANDARD_DEVIATION 14.77 • n=285 Participants
|
7.6 months
STANDARD_DEVIATION 19.11 • n=279 Participants
|
6.7 months
STANDARD_DEVIATION 17.07 • n=564 Participants
|
|
Disease free interval
|
43.6 months
STANDARD_DEVIATION 48.84 • n=285 Participants
|
48.0 months
STANDARD_DEVIATION 48.53 • n=279 Participants
|
45.8 months
STANDARD_DEVIATION 48.70 • n=564 Participants
|
|
Number of target lesions
|
2.7 number of lesions
STANDARD_DEVIATION 2.52 • n=285 Participants
|
2.8 number of lesions
STANDARD_DEVIATION 2.42 • n=279 Participants
|
2.7 number of lesions
STANDARD_DEVIATION 2.47 • n=564 Participants
|
|
Sum of longest diameter of target lesions
|
6.758 cm
STANDARD_DEVIATION 7.4372 • n=285 Participants
|
6.872 cm
STANDARD_DEVIATION 6.6679 • n=279 Participants
|
6.815 cm
STANDARD_DEVIATION 7.0610 • n=564 Participants
|
|
Weight
|
71.97 kg
STANDARD_DEVIATION 15.679 • n=285 Participants
|
72.90 kg
STANDARD_DEVIATION 14.350 • n=279 Participants
|
72.43 kg
STANDARD_DEVIATION 15.030 • n=564 Participants
|
PRIMARY outcome
Timeframe: Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 yearsPopulation: Per Protocol Population (PP)
Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 47% of information was 0.0010. Alpha spent at final analysis after 99% of information was 0.0250.
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=266 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=265 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Overall Survival (PP Population)
|
30.2 months
Interval 25.6 to 32.6
|
26.1 months
Interval 22.3 to 29.0
|
PRIMARY outcome
Timeframe: Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 yearsPopulation: Intent-to-Treat Population (ITT)
Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 50% of information was 0.0014. Alpha spent at final analysis after 99% of information was 0.0250.
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=285 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=279 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Overall Survival (ITT Population)
|
29.5 months
Interval 25.3 to 32.4
|
26.0 months
Interval 22.3 to 29.0
|
SECONDARY outcome
Timeframe: Up to approximately 6 yearsPopulation: Intention-to-Treat population
Median observation time estimated with reverse Kaplan-Meier methods. Observation time (in months) is defined as time from randomization to the day the patient was last confirmed to be alive. In case of patient deaths the time was censored at the day of death.
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=285 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=279 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Observation Time (ITT Population)
|
54.3 months
Interval 53.1 to 57.5
|
55.7 months
Interval 53.7 to 58.1
|
SECONDARY outcome
Timeframe: Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.Population: Intent-to-Treat population
The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=285 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=279 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Best Overall Response (ITT Population)
Complete response
|
10 Participants
|
2 Participants
|
|
Best Overall Response (ITT Population)
Partial response
|
115 Participants
|
74 Participants
|
|
Best Overall Response (ITT Population)
Stable disease
|
127 Participants
|
138 Participants
|
|
Best Overall Response (ITT Population)
Progressive disease
|
18 Participants
|
47 Participants
|
|
Best Overall Response (ITT Population)
Not evaluable
|
15 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.Population: Per protocol population
The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=266 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=265 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Best Overall Response (PP Population)
Complete response
|
10 Participants
|
2 Participants
|
|
Best Overall Response (PP Population)
Partial response
|
111 Participants
|
72 Participants
|
|
Best Overall Response (PP Population)
Stable disease
|
117 Participants
|
130 Participants
|
|
Best Overall Response (PP Population)
Progressive disease
|
17 Participants
|
45 Participants
|
|
Best Overall Response (PP Population)
Not evaluable
|
11 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.Population: ITT population
The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment.
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=285 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=279 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Unconfirmed Best Overall Response (ITT Population)
Complete response
|
16 Participants
|
4 Participants
|
|
Unconfirmed Best Overall Response (ITT Population)
Partial response
|
147 Participants
|
101 Participants
|
|
Unconfirmed Best Overall Response (ITT Population)
Stable disease
|
89 Participants
|
109 Participants
|
|
Unconfirmed Best Overall Response (ITT Population)
Progressive disease
|
18 Participants
|
47 Participants
|
|
Unconfirmed Best Overall Response (ITT Population)
Not evaluable
|
15 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.Population: PP population
The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment.
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=266 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=265 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Unconfirmed Best Overall Response (PP Population)
Not evaluable
|
11 Participants
|
16 Participants
|
|
Unconfirmed Best Overall Response (PP Population)
Complete response
|
16 Participants
|
4 Participants
|
|
Unconfirmed Best Overall Response (PP Population)
Partial response
|
141 Participants
|
96 Participants
|
|
Unconfirmed Best Overall Response (PP Population)
Stable disease
|
81 Participants
|
104 Participants
|
|
Unconfirmed Best Overall Response (PP Population)
Progressive disease
|
17 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.Population: ITT population
Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=285 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=279 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Objective Response Rate and Disease Control Rate (ITT Population)
Objective response
|
125 Participants
|
76 Participants
|
|
Objective Response Rate and Disease Control Rate (ITT Population)
Disease control
|
252 Participants
|
214 Participants
|
SECONDARY outcome
Timeframe: Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.Population: PP population
Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=266 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=265 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Objective Response Rate and Disease Control Rate (PP Population)
Objective response
|
121 Participants
|
74 Participants
|
|
Objective Response Rate and Disease Control Rate (PP Population)
Disease control
|
238 Participants
|
204 Participants
|
SECONDARY outcome
Timeframe: Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.Population: ITT population
Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment.
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=285 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=279 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Unconfirmed Objective Response Rate and Disease Control Rate (ITT Population)
Objective response
|
163 Participants
|
105 Participants
|
|
Unconfirmed Objective Response Rate and Disease Control Rate (ITT Population)
Disease control
|
252 Participants
|
214 Participants
|
SECONDARY outcome
Timeframe: Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.Population: PP population
Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=266 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=265 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Unconfirmed Objective Response Rate and Disease Control Rate (PP Population)
Objective response
|
157 Participants
|
100 Participants
|
|
Unconfirmed Objective Response Rate and Disease Control Rate (PP Population)
Disease control
|
238 Participants
|
204 Participants
|
SECONDARY outcome
Timeframe: Time from the date of randomization to disease progression, death or censoring (whichever occurred first), assessed up to approximately 5 years.Population: ITT population
Progression Free Survival (PFS) is defined as time from randomization to date of documented progression or date of death due to any cause, whichever occurred first. Patients without recorded progression or death were censored at the last date they were known to have not progressed. Patients who were randomized and had no post-baseline tumor assessment were censored on the day of randomization. Median PFS, associated stratified Hazard Ratio (HR).
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=285 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=279 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Progression Free Survival (ITT Population)
|
10.9 months
Interval 10.3 to 12.9
|
8.1 months
Interval 6.8 to 8.9
|
SECONDARY outcome
Timeframe: Time from the date of randomization to disease progression, death or censoring (whichever occurred first), assessed up to approximately 5 years.Population: PP population
Progression Free Survival (PFS) is defined as time from randomization to date of documented progression or date of death due to any cause, whichever occurred first. Patients without recorded progression or death were censored at the last date they were known to have not progressed. Patients who were randomized and had no post-baseline tumor assessment were censored on the day of randomization. Median PFS, associated stratified Hazard Ratio (HR).
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=266 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=265 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Progression Free Survival (PP Population)
|
10.9 months
Interval 10.3 to 12.9
|
8.2 months
Interval 7.1 to 9.2
|
SECONDARY outcome
Timeframe: From first drug intake to progression, death or withdrawal from study treatment or study closure (whichever occurred first), assessed up to approximately 4.5 yearsPopulation: ITT population
Time to treatment failure (TTF) was defined as time from first drug intake to progression, death or withdrawal from study treatment, whichever occurred first. Patients without an event were censored at the date of the last tumor assessment or last treatment administration, whichever occurred last. Median TTF, associated stratified Hazard Ratio (HR).
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=285 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=279 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Time to Treatment Failure (ITT Population)
|
8.4 months
Interval 8.0 to 9.7
|
7.2 months
Interval 6.0 to 8.1
|
SECONDARY outcome
Timeframe: From first drug intake to progression, death or withdrawal from study treatment or study closure (whichever occurred first), assessed up to approximately 4.5 yearsPopulation: PP population
Time to treatment failure (TTF) was defined as time from first drug intake to progression, death or withdrawal from study treatment, whichever occurred first. Patients without an event were censored at the date of the last tumor assessment or last treatment administration, whichever occurred last. Median TTF, associated stratified Hazard Ratio (HR).
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=266 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=265 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Time to Treatment Failure (PP Population)
|
8.3 months
Interval 8.0 to 9.4
|
7.3 months
Interval 5.9 to 8.2
|
SECONDARY outcome
Timeframe: Time from randomization until occurrence of response, assessed up 1.7 yearsPopulation: ITT population, median not reached
Time to response (TR) was defined as time from randomization until occurrence of response (complete response (CR) or partial response (PR)) according to RECIST criteria. Patients without response were censored after the longest time to response observed in any patient. Median TR, associated stratified Hazard Ratio (HR). Since the median TR was not observed, the number of subjects with a response at given timepoints were reported.
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=285 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=279 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Time to Response (ITT Population)
Month 15
|
123 Participants
|
75 Participants
|
|
Time to Response (ITT Population)
Month 3
|
83 Participants
|
57 Participants
|
|
Time to Response (ITT Population)
Month 6
|
111 Participants
|
69 Participants
|
|
Time to Response (ITT Population)
Month 9
|
121 Participants
|
74 Participants
|
|
Time to Response (ITT Population)
Month 12
|
123 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: Time from randomization until occurrence of response, assessed up 1.7 yearsPopulation: PP population, median not reached
Time to response (TR) was defined as time from randomization until occurrence of response (complete response (CR) or partial response (PR)) according to RECIST criteria. Patients without response were censored after the longest time to response observed in any patient. Median TR, associated stratified Hazard Ratio (HR). Since the median TR was not observed, the number of subjects with a response at given timepoints were reported.
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=266 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=265 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Time to Response (PP Population)
Month 3
|
81 Participants
|
56 Participants
|
|
Time to Response (PP Population)
Month 6
|
108 Participants
|
68 Participants
|
|
Time to Response (PP Population)
Month 9
|
118 Participants
|
72 Participants
|
|
Time to Response (PP Population)
Month 12
|
119 Participants
|
73 Participants
|
|
Time to Response (PP Population)
Month 15
|
119 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: Time from first occurrence of CR or PR until disease progression, death or study closure, whichever occurred first, assessed up to 3.4 years after occurrence of response.Population: ITT population restricted to patients who experienced a partial or complete response
Duration of response (DR) was defined as time from date of first occurrence of any response (complete response (CR) or partial response (PR)) until the occurrence of progression of disease or death. Patients with response who neither progressed nor died were censored at the date of their last tumor assessment. Median DR, associated stratified Hazard Ratio (HR).
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=125 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=76 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Duration of Response (ITT Population)
|
11.2 months
Interval 10.1 to 14.0
|
10.3 months
Interval 8.6 to 12.4
|
SECONDARY outcome
Timeframe: Time from first occurrence of CR or PR until disease progression, death or study closure, whichever occurred first, assessed up to 3.4 years after occurrence of response.Population: PP population restricted to patients who experienced a partial or complete response
Duration of response (DR) was defined as time from date of first occurrence of any response (complete response (CR) or partial response (PR)) until the occurrence of progression of disease or death. Patients with response who neither progressed nor died were censored at the date of their last tumor assessment. Median DR, associated stratified Hazard Ratio (HR).
Outcome measures
| Measure |
Bevacizumab Plus Paclitaxel
n=121 Participants
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=74 Participants
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Duration of Response (PP Population)
|
11.2 months
Interval 9.5 to 14.2
|
10.3 months
Interval 8.4 to 12.4
|
Adverse Events
Bevacizumab Plus Paclitaxel
Serious events: 65 serious events
Other events: 264 other events
Deaths: 196 deaths
Bevacizumab Plus Capecitabine
Serious events: 68 serious events
Other events: 240 other events
Deaths: 209 deaths
Serious adverse events
| Measure |
Bevacizumab Plus Paclitaxel
n=284 participants at risk
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=277 participants at risk
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
1.4%
4/277 • Number of events 5 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.70%
2/284 • Number of events 2 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Cardiac disorders
Atrial fibrillation
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Cardiac disorders
Atrioventricular block
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Cardiac disorders
Systolic dysfunction
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.72%
2/277 • Number of events 2 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Ascites
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Constipation
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
1.4%
4/277 • Number of events 4 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Melaena
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Nausea
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.72%
2/277 • Number of events 2 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.72%
2/277 • Number of events 3 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
General disorders
Catheter site pain
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
General disorders
Chest pain
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
General disorders
Death
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
General disorders
Fatigue
|
0.70%
2/284 • Number of events 2 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
General disorders
Gait disturbance
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
General disorders
General physical health deterioration
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
General disorders
Generalised oedema
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
General disorders
Pain
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
General disorders
Pyrexia
|
1.1%
3/284 • Number of events 3 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Immune system disorders
Drug hypersensitivity
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Immune system disorders
Hypersensitivity
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Infections and infestations
Abscess limb
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Infections and infestations
Atypical pneumonia
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Infections and infestations
Catheter site infection
|
1.1%
3/284 • Number of events 3 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Infections and infestations
Herpes zoster
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Infections and infestations
Lung infection
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Infections and infestations
Pneumonia
|
1.1%
3/284 • Number of events 4 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Infections and infestations
Skin infection
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Infections and infestations
Tooth abscess
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Investigations
Hepatic enzyme increased
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.72%
2/277 • Number of events 3 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.72%
2/277 • Number of events 2 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.70%
2/284 • Number of events 2 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
1.1%
3/277 • Number of events 3 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Brain hypoxia
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Brain oedema
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 2 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Dizziness
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Headache
|
0.70%
2/284 • Number of events 2 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.72%
2/277 • Number of events 2 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Ischaemic stroke
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Syncope
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.72%
2/277 • Number of events 2 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Psychiatric disorders
Depression
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Psychiatric disorders
Hallucination, olfactory
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.70%
2/284 • Number of events 2 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
2.2%
6/277 • Number of events 6 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.70%
2/284 • Number of events 3 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
1.1%
3/277 • Number of events 3 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.70%
2/284 • Number of events 2 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
1.4%
4/277 • Number of events 4 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Surgical and medical procedures
Breast lump removal
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Surgical and medical procedures
Catheterisation venous
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Surgical and medical procedures
Tooth extraction
|
0.70%
2/284 • Number of events 2 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Vascular disorders
Aortic thrombosis
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Vascular disorders
Deep vein thrombosis
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
1.8%
5/277 • Number of events 5 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Vascular disorders
Haemorrhage
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Vascular disorders
Hypertension
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.72%
2/277 • Number of events 2 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Vascular disorders
Hypovolaemic shock
|
0.35%
1/284 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.00%
0/277 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/284 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
0.36%
1/277 • Number of events 1 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
Other adverse events
| Measure |
Bevacizumab Plus Paclitaxel
n=284 participants at risk
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
|
Bevacizumab Plus Capecitabine
n=277 participants at risk
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.3%
35/284 • Number of events 59 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
6.1%
17/277 • Number of events 20 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.2%
46/284 • Number of events 127 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
2.2%
6/277 • Number of events 8 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.6%
87/284 • Number of events 204 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
4.7%
13/277 • Number of events 24 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.2%
9/284 • Number of events 12 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
6.9%
19/277 • Number of events 26 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
20/284 • Number of events 26 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
6.5%
18/277 • Number of events 21 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.3%
18/284 • Number of events 24 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
5.1%
14/277 • Number of events 17 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Constipation
|
9.5%
27/284 • Number of events 32 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
9.0%
25/277 • Number of events 32 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.4%
58/284 • Number of events 83 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
21.3%
59/277 • Number of events 83 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.0%
17/284 • Number of events 24 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
5.4%
15/277 • Number of events 17 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Nausea
|
20.1%
57/284 • Number of events 82 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
25.3%
70/277 • Number of events 94 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
22/284 • Number of events 27 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
7.2%
20/277 • Number of events 24 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Gastrointestinal disorders
Vomiting
|
10.2%
29/284 • Number of events 40 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
12.3%
34/277 • Number of events 46 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
General disorders
Asthenia
|
15.5%
44/284 • Number of events 50 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
12.3%
34/277 • Number of events 37 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
General disorders
Fatigue
|
34.2%
97/284 • Number of events 127 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
27.4%
76/277 • Number of events 89 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
General disorders
Mucosal inflammation
|
8.1%
23/284 • Number of events 29 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
4.7%
13/277 • Number of events 13 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
General disorders
Oedema peripheral
|
9.5%
27/284 • Number of events 28 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
4.0%
11/277 • Number of events 13 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
General disorders
Pyrexia
|
8.1%
23/284 • Number of events 27 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
6.1%
17/277 • Number of events 20 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.1%
3/284 • Number of events 3 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
5.8%
16/277 • Number of events 18 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Infections and infestations
Urinary tract infection
|
8.5%
24/284 • Number of events 29 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
5.1%
14/277 • Number of events 18 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.3%
35/284 • Number of events 38 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
11.9%
33/277 • Number of events 38 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
30/284 • Number of events 58 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
6.5%
18/277 • Number of events 20 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
27/284 • Number of events 35 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
10.5%
29/277 • Number of events 29 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.9%
28/284 • Number of events 33 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
10.5%
29/277 • Number of events 31 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.1%
3/284 • Number of events 5 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
5.1%
14/277 • Number of events 15 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.0%
20/284 • Number of events 26 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
3.2%
9/277 • Number of events 9 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.8%
25/284 • Number of events 32 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
8.7%
24/277 • Number of events 28 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Dizziness
|
11.6%
33/284 • Number of events 39 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
6.1%
17/277 • Number of events 19 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Dysgeusia
|
6.0%
17/284 • Number of events 19 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
3.6%
10/277 • Number of events 14 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Headache
|
13.0%
37/284 • Number of events 46 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
9.7%
27/277 • Number of events 32 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Neuropathy peripheral
|
30.3%
86/284 • Number of events 105 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
3.2%
9/277 • Number of events 9 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Paraesthesia
|
6.0%
17/284 • Number of events 18 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
4.3%
12/277 • Number of events 12 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.1%
23/284 • Number of events 25 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
1.8%
5/277 • Number of events 5 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Nervous system disorders
Polyneuropathy
|
9.5%
27/284 • Number of events 35 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
2.2%
6/277 • Number of events 7 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Renal and urinary disorders
Proteinuria
|
3.5%
10/284 • Number of events 13 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
5.8%
16/277 • Number of events 16 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.3%
32/284 • Number of events 37 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
7.2%
20/277 • Number of events 22 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
12.3%
35/284 • Number of events 37 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
3.6%
10/277 • Number of events 11 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.3%
32/284 • Number of events 39 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
8.7%
24/277 • Number of events 27 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
31.3%
89/284 • Number of events 122 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
14.1%
39/277 • Number of events 46 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
30.6%
87/284 • Number of events 88 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
1.8%
5/277 • Number of events 5 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
16.9%
48/284 • Number of events 50 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
3.6%
10/277 • Number of events 10 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
2.8%
8/284 • Number of events 8 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
56.0%
155/277 • Number of events 197 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.0%
17/284 • Number of events 20 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
4.0%
11/277 • Number of events 14 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
|
Vascular disorders
Hypertension
|
35.9%
102/284 • Number of events 192 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
30.0%
83/277 • Number of events 130 • From start of study drug administration until 28 days after the last dose of study medication, assessed up to approximately 5 years
The safety population comprised all patients randomized who received at least one dose of study medication. For the purpose of safety analyses, patients were included in the treatment groups of the treatment actually received. However, if patients received only one component of the assigned combination treatment (e.g. only paclitaxel in group A), then they were analyzed under the Treatment group randomized. 1 patient in Arm A and 2 patients in Arm B were not treated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place