Trial Outcomes & Findings for A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA) (NCT NCT01026142)
NCT ID: NCT01026142
Last Updated: 2018-08-14
Results Overview
Progression Free Survival (PFS) was defined as the time from randomization to first documented disease progression (PD), as determined by an Independent Review Facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. IRF review of tumor assessment ceased after the primary PFS analysis. The primary endpoint was analyzed after approximately 337 IRF-assessed PFS events were observed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
452 participants
Primary outcome timeframe
Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).
Results posted on
2018-08-14
Participant Flow
452 participants were randomized to one of two treatment arms: trastuzumab and capecitabine (Arm A, 224 participants) or pertuzumab with trastuzumab and capecitabine (Arm B, 228 participants). Of participants randomized to Arm A: trastuzumab and capecitabine, 6 participants did not receive study treatment.
Participant milestones
| Measure |
A: Capecitabine + Trastuzumab
Capecitabine \[Xeloda\]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
B: Capecitabine + Trastuzumab + Pertuzumab
Capecitabine \[Xeloda\]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab \[Perjeta\]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
224
|
228
|
|
Overall Study
COMPLETED
|
52
|
65
|
|
Overall Study
NOT COMPLETED
|
172
|
163
|
Reasons for withdrawal
| Measure |
A: Capecitabine + Trastuzumab
Capecitabine \[Xeloda\]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
B: Capecitabine + Trastuzumab + Pertuzumab
Capecitabine \[Xeloda\]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab \[Perjeta\]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
|---|---|---|
|
Overall Study
Death
|
136
|
134
|
|
Overall Study
Withdrew consent or lost to follow-up
|
36
|
29
|
Baseline Characteristics
A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA)
Baseline characteristics by cohort
| Measure |
A: Capecitabine + Trastuzumab
n=218 Participants
Capecitabine \[Xeloda\]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
B: Capecitabine + Trastuzumab + Pertuzumab
n=228 Participants
Capecitabine \[Xeloda\]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab \[Perjeta\]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
Total
n=446 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
Germany
|
23 participants
n=93 Participants
|
11 participants
n=4 Participants
|
34 participants
n=27 Participants
|
|
Region of Enrollment
Croatia
|
4 participants
n=93 Participants
|
3 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 10.10 • n=93 Participants
|
53.0 years
STANDARD_DEVIATION 11.21 • n=4 Participants
|
54.0 years
STANDARD_DEVIATION 10.72 • n=27 Participants
|
|
Sex: Female, Male
Female
|
218 Participants
n=93 Participants
|
228 Participants
n=4 Participants
|
446 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Russian Federation
|
8 participants
n=93 Participants
|
3 participants
n=4 Participants
|
11 participants
n=27 Participants
|
|
Region of Enrollment
Argentina
|
3 participants
n=93 Participants
|
4 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Region of Enrollment
Romania
|
6 participants
n=93 Participants
|
8 participants
n=4 Participants
|
14 participants
n=27 Participants
|
|
Region of Enrollment
Hungary
|
13 participants
n=93 Participants
|
29 participants
n=4 Participants
|
42 participants
n=27 Participants
|
|
Region of Enrollment
Hong Kong
|
5 participants
n=93 Participants
|
11 participants
n=4 Participants
|
16 participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
18 participants
n=93 Participants
|
17 participants
n=4 Participants
|
35 participants
n=27 Participants
|
|
Region of Enrollment
Thailand
|
0 participants
n=93 Participants
|
5 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
39 participants
n=93 Participants
|
31 participants
n=4 Participants
|
70 participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=93 Participants
|
6 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Region of Enrollment
Czech Republic
|
12 participants
n=93 Participants
|
10 participants
n=4 Participants
|
22 participants
n=27 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=93 Participants
|
3 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
12 participants
n=93 Participants
|
11 participants
n=4 Participants
|
23 participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
6 participants
n=93 Participants
|
6 participants
n=4 Participants
|
12 participants
n=27 Participants
|
|
Region of Enrollment
Brazil
|
7 participants
n=93 Participants
|
6 participants
n=4 Participants
|
13 participants
n=27 Participants
|
|
Region of Enrollment
Korea, Republic of
|
14 participants
n=93 Participants
|
24 participants
n=4 Participants
|
38 participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
16 participants
n=93 Participants
|
18 participants
n=4 Participants
|
34 participants
n=27 Participants
|
|
Region of Enrollment
Mexico
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
France
|
19 participants
n=93 Participants
|
12 participants
n=4 Participants
|
31 participants
n=27 Participants
|
|
Region of Enrollment
Peru
|
7 participants
n=93 Participants
|
8 participants
n=4 Participants
|
15 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).Population: All randomized participants.
Progression Free Survival (PFS) was defined as the time from randomization to first documented disease progression (PD), as determined by an Independent Review Facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. IRF review of tumor assessment ceased after the primary PFS analysis. The primary endpoint was analyzed after approximately 337 IRF-assessed PFS events were observed.
Outcome measures
| Measure |
A: Capecitabine + Trastuzumab
n=224 Participants
Capecitabine \[Xeloda\]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
B: Capecitabine + Trastuzumab + Pertuzumab
n=228 Participants
Capecitabine \[Xeloda\]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab \[Perjeta\]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
|---|---|---|
|
Progression Free Survival (Independent Assessment)
|
9.0 months
Interval 8.0 to 10.0
|
11.1 months
Interval 9.0 to 13.0
|
SECONDARY outcome
Timeframe: From randomization until death from any cause (up to 7.5 years).Population: All randomized participants.
Overall Survival (OS) was defined as the time from the date of randomization to the date of death from any cause. The results of the final OS analysis are presented here. Participants who were alive or lost to follow-up at the time of the analysis were censored at the last known alive date. Participants with no postbaseline information were censored at the time of randomization plus 1 day. Prior to the final data analysis cut-off, it was ensured that all participants who were in survival follow-up had been contacted as recently as possible within the last 3 months to confirm current survival status.
Outcome measures
| Measure |
A: Capecitabine + Trastuzumab
n=224 Participants
Capecitabine \[Xeloda\]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
B: Capecitabine + Trastuzumab + Pertuzumab
n=228 Participants
Capecitabine \[Xeloda\]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab \[Perjeta\]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
|---|---|---|
|
Overall Survival (OS)
|
28.1 Months
Interval 22.0 to 35.0
|
37.2 Months
Interval 33.0 to 42.0
|
SECONDARY outcome
Timeframe: From randomization until death from any cause (up to 2 years)Population: All randomized participants.
The Overall Survival (OS) 2-year truncated analysis is the Kaplan-Meier estimate of the percentage of participants who were surviving at 2 years. OS is defined as the time from the date of randomization to the date of death from any cause, with censoring of all events and follow-up beyond the end of the second year.
Outcome measures
| Measure |
A: Capecitabine + Trastuzumab
n=224 Participants
Capecitabine \[Xeloda\]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
B: Capecitabine + Trastuzumab + Pertuzumab
n=228 Participants
Capecitabine \[Xeloda\]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab \[Perjeta\]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
|---|---|---|
|
Overall Survival (OS) Rate Based on a 2-year Truncated Analysis
|
55.0 Percentage of participants
Interval 48.07 to 61.85
|
74.9 Percentage of participants
Interval 69.05 to 80.68
|
SECONDARY outcome
Timeframe: Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 7.5 years).Population: All randomized participants.
Investigator Assessment Progression-Free Survival (PFS) was defined as the time from randomization to the first documented progressive disease, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, or death from any cause, whichever occurred first. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
A: Capecitabine + Trastuzumab
n=224 Participants
Capecitabine \[Xeloda\]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
B: Capecitabine + Trastuzumab + Pertuzumab
n=228 Participants
Capecitabine \[Xeloda\]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab \[Perjeta\]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
|---|---|---|
|
Investigator Assessment Progression-Free Survival (PFS)
|
9.0 Months
Interval 8.0 to 12.0
|
11.8 Months
Interval 9.0 to 14.0
|
SECONDARY outcome
Timeframe: Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).Population: All randomized participants.
Time to Progression (TTP) was defined as time between randomization and the first occurrence of progressive disease (PD), based on IRF assessment.
Outcome measures
| Measure |
A: Capecitabine + Trastuzumab
n=224 Participants
Capecitabine \[Xeloda\]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
B: Capecitabine + Trastuzumab + Pertuzumab
n=228 Participants
Capecitabine \[Xeloda\]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab \[Perjeta\]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
|---|---|---|
|
Time to Progression (TTP) Based Upon Independent Review Facility (IRF) Assessment
|
39.0 Weeks
Interval 35.0 to 44.0
|
50.6 Weeks
Interval 39.0 to 62.0
|
SECONDARY outcome
Timeframe: Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).Population: All randomized participants.
Time to Treatment Failure (TTF) was defined as time between randomization and date of disease progression based on independent review, death, or withdrawal of treatment due to adverse events, withdrawn informed consent, refusal of treatment/failure to cooperate, or failure to return, whichever occurred first.
Outcome measures
| Measure |
A: Capecitabine + Trastuzumab
n=224 Participants
Capecitabine \[Xeloda\]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
B: Capecitabine + Trastuzumab + Pertuzumab
n=228 Participants
Capecitabine \[Xeloda\]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab \[Perjeta\]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
|---|---|---|
|
Time to Treatment Failure (TTF) Based Upon Independent Review Facility (IRF) Assessment
|
39.0 Weeks
Interval 34.0 to 44.0
|
50.9 Weeks
Interval 39.0 to 62.0
|
SECONDARY outcome
Timeframe: Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).Population: Participants without a post-baseline tumor assessment were considered to be non-responders and were not included in this outcome measure.
Overall Objective Response Rate is based upon investigator and IRF assessments. Objective Response Rate (ORR) was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) among those who had measurable disease at baseline. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
A: Capecitabine + Trastuzumab
n=164 Participants
Capecitabine \[Xeloda\]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
B: Capecitabine + Trastuzumab + Pertuzumab
n=163 Participants
Capecitabine \[Xeloda\]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab \[Perjeta\]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
|---|---|---|
|
Overall Objective Response Rate (ORR)
Complete Response (CR) - IRF Assessment
|
0 Percentage of participants
|
1.8 Percentage of participants
|
|
Overall Objective Response Rate (ORR)
Partial Response (PR) - IRF assessment
|
32.9 Percentage of participants
|
38.7 Percentage of participants
|
|
Overall Objective Response Rate (ORR)
Complete Response (CR) - Investigator Assessed
|
1.2 Percentage of participants
|
6.7 Percentage of participants
|
|
Overall Objective Response Rate (ORR)
Partial Response (PR) - Investigator Assessed
|
36.0 Percentage of participants
|
38.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).Population: Participants without a post-baseline tumor assessment were considered to be non-responders and were not included in this outcome measure.
Clinical Benefit Rate is based upon Independent Review Facility (IRF) assessments; defined as the percentage of participants a complete response (CR), partial response (PR), or stable disease for at least 8 cycles or 6 months.
Outcome measures
| Measure |
A: Capecitabine + Trastuzumab
n=224 Participants
Capecitabine \[Xeloda\]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
B: Capecitabine + Trastuzumab + Pertuzumab
n=228 Participants
Capecitabine \[Xeloda\]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab \[Perjeta\]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
|---|---|---|
|
Clinical Benefit Rate (CBR)
|
54.0 Percentage of participants
Interval 47.3 to 60.7
|
63.6 Percentage of participants
Interval 57.0 to 69.8
|
SECONDARY outcome
Timeframe: Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).Duration of Objective Response was defined for the subpopulation of responders as time from first Independent Review Facility (IRF)-assessed complete response (CR) or partial response (PR) to subsequent first documented, IRF-confirmed evidence of disease progression. Only participants with an objective response were included in the analysis of duration of objective response.
Outcome measures
| Measure |
A: Capecitabine + Trastuzumab
n=54 Participants
Capecitabine \[Xeloda\]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
B: Capecitabine + Trastuzumab + Pertuzumab
n=66 Participants
Capecitabine \[Xeloda\]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab \[Perjeta\]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
|---|---|---|
|
Duration of Objective Response
|
30.0 Weeks
Interval 21.0 to 42.0
|
51.6 Weeks
Interval 42.0 to 57.0
|
Adverse Events
A: Capecitabine + Trastuzumab
Serious events: 53 serious events
Other events: 209 other events
Deaths: 136 deaths
B: Capecitabine + Trastuzumab + Pertuzumab
Serious events: 58 serious events
Other events: 216 other events
Deaths: 134 deaths
Serious adverse events
| Measure |
A: Capecitabine + Trastuzumab
n=218 participants at risk
Capecitabine \[Xeloda\]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
B: Capecitabine + Trastuzumab + Pertuzumab
n=228 participants at risk
Capecitabine \[Xeloda\]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab \[Perjeta\]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
6/218 • Number of events 6 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
3.5%
8/228 • Number of events 8 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Gastrointestinal disorders
Nausea
|
0.92%
2/218 • Number of events 2 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Gastrointestinal disorders
Vomiting
|
0.92%
2/218 • Number of events 2 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Gastrointestinal disorders
Diverticulum
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Gastrointestinal disorders
Gastric Perforation
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Gastrointestinal disorders
Ileus
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
1.8%
4/218 • Number of events 4 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
5.7%
13/228 • Number of events 13 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.88%
2/228 • Number of events 2 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Cardiac disorders
Arteriospasm Coronary
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Cardiac disorders
Cardiac Arrest
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.92%
2/218 • Number of events 2 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.88%
2/228 • Number of events 2 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.88%
2/228 • Number of events 2 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Injury, poisoning and procedural complications
Acetabulum Fracture
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Injury, poisoning and procedural complications
Bone Fissure
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Injury, poisoning and procedural complications
Craniocerebral Injury
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Injury, poisoning and procedural complications
Synovial Rupture
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Infections and infestations
Sepsis
|
0.92%
2/218 • Number of events 2 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Infections and infestations
Appendicitis
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Infections and infestations
Bacteraemia
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Infections and infestations
Catheter Site Infection
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Infections and infestations
Device Related Infection
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Infections and infestations
Gastroenteritis
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Infections and infestations
Phlebitis Infective
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Infections and infestations
Pneumonia
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Nervous system disorders
Syncope
|
0.92%
2/218 • Number of events 2 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Nervous system disorders
Dizziness
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Nervous system disorders
Hemiparesis
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Nervous system disorders
Secondary Cerebellar Degeneration
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Nervous system disorders
Status Epilepticus
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Injury, poisoning and procedural complications
Subarachnoid Haemorrhage
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.8%
4/218 • Number of events 4 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
1.3%
3/228 • Number of events 4 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Thrombosis
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.88%
2/228 • Number of events 2 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
General disorders
General Physical Health Deterioration
|
0.92%
2/218 • Number of events 2 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.88%
2/228 • Number of events 2 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
General disorders
Pyrexia
|
0.92%
2/218 • Number of events 2 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.88%
2/228 • Number of events 2 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
General disorders
Chest Pain
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
General disorders
Device Related Thrombosis
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.92%
2/218 • Number of events 2 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.92%
2/218 • Number of events 2 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.46%
1/218 • Number of events 2 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.88%
2/228 • Number of events 2 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Vascular disorders
Vena Cava Thrombosis
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.88%
2/228 • Number of events 2 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Vascular disorders
Hypertension
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Vascular disorders
Venous Thrombosis
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Promyelocytic Leukaemia
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Psychiatric disorders
Delirium
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Psychiatric disorders
Depression
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Immune system disorders
Anaphylactic Shock
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Investigations
Blood Sodium Decreased
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Renal and urinary disorders
Ureteric Stenosis
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Reproductive system and breast disorders
Endometrial Hyperplasia
|
0.00%
0/218 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.44%
1/228 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.46%
1/218 • Number of events 1 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
0.00%
0/228 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
Other adverse events
| Measure |
A: Capecitabine + Trastuzumab
n=218 participants at risk
Capecitabine \[Xeloda\]: 1250 mg/m2 po twice daily for 14 days every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
B: Capecitabine + Trastuzumab + Pertuzumab
n=228 participants at risk
Capecitabine \[Xeloda\]: 1000 mg/m2 po twice daily for 14 days every 3 weeks. Pertuzumab \[Perjeta\]: 840 mg iv loading, then 420 mg iv every 3 weeks. Trastuzumab \[Herceptin\]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks.
|
|---|---|---|
|
Infections and infestations
Influenza
|
1.8%
4/218 • Number of events 5 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
5.3%
12/228 • Number of events 12 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.1%
22/218 • Number of events 27 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
13.2%
30/228 • Number of events 38 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.0%
24/218 • Number of events 28 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
9.2%
21/228 • Number of events 25 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.1%
9/218 • Number of events 9 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
5.3%
12/228 • Number of events 14 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
12.8%
28/218 • Number of events 43 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
15.8%
36/228 • Number of events 43 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.0%
13/218 • Number of events 19 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
12.3%
28/228 • Number of events 40 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
17.4%
38/218 • Number of events 89 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
12.7%
29/228 • Number of events 74 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.8%
17/218 • Number of events 23 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
9.2%
21/228 • Number of events 28 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Investigations
Weight Decreased
|
6.0%
13/218 • Number of events 14 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
8.3%
19/228 • Number of events 20 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.0%
11/218 • Number of events 15 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
7.5%
17/228 • Number of events 26 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Investigations
Alanine Aminotransferase Increased
|
3.7%
8/218 • Number of events 11 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
7.5%
17/228 • Number of events 24 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Psychiatric disorders
Insomnia
|
5.5%
12/218 • Number of events 17 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
10.1%
23/228 • Number of events 27 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Vascular disorders
Hypertension
|
6.4%
14/218 • Number of events 18 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
8.3%
19/228 • Number of events 19 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Eye disorders
Lacrimation Increased
|
6.0%
13/218 • Number of events 17 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
2.6%
6/228 • Number of events 8 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
2.3%
5/218 • Number of events 5 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
5.7%
13/228 • Number of events 15 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Gastrointestinal disorders
Diarrhoea
|
58.7%
128/218 • Number of events 275 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
68.9%
157/228 • Number of events 436 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Gastrointestinal disorders
Nausea
|
44.5%
97/218 • Number of events 152 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
38.6%
88/228 • Number of events 129 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Gastrointestinal disorders
Vomiting
|
20.6%
45/218 • Number of events 56 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
16.2%
37/228 • Number of events 58 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Gastrointestinal disorders
Stomatitis
|
14.7%
32/218 • Number of events 39 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
18.0%
41/228 • Number of events 60 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Gastrointestinal disorders
Abdominal Pain
|
13.8%
30/218 • Number of events 36 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
12.3%
28/228 • Number of events 50 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
11.0%
24/218 • Number of events 31 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
12.7%
29/228 • Number of events 45 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.1%
22/218 • Number of events 23 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
10.5%
24/228 • Number of events 33 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Gastrointestinal disorders
Constipation
|
9.6%
21/218 • Number of events 27 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
7.9%
18/228 • Number of events 22 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
72.9%
159/218 • Number of events 242 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
56.6%
129/228 • Number of events 179 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
11/218 • Number of events 12 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
15.4%
35/228 • Number of events 45 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
7/218 • Number of events 7 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
9.2%
21/228 • Number of events 29 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
4.1%
9/218 • Number of events 10 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
7.0%
16/228 • Number of events 17 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
3.7%
8/218 • Number of events 8 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
6.1%
14/228 • Number of events 15 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
11/218 • Number of events 12 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
2.6%
6/228 • Number of events 6 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
General disorders
Asthenia
|
23.4%
51/218 • Number of events 87 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
20.6%
47/228 • Number of events 77 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
General disorders
Fatigue
|
17.9%
39/218 • Number of events 59 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
19.3%
44/228 • Number of events 62 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
General disorders
Mucosal Inflammation
|
12.4%
27/218 • Number of events 36 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
14.0%
32/228 • Number of events 45 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
General disorders
Pyrexia
|
9.2%
20/218 • Number of events 24 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
12.7%
29/228 • Number of events 41 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
General disorders
Oedema Peripheral
|
6.0%
13/218 • Number of events 13 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
7.9%
18/228 • Number of events 19 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
General disorders
Chest Pain
|
5.5%
12/218 • Number of events 15 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
3.9%
9/228 • Number of events 11 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
6.9%
15/218 • Number of events 24 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
11.8%
27/228 • Number of events 32 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
17/218 • Number of events 19 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
9.2%
21/228 • Number of events 27 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.3%
18/218 • Number of events 23 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
8.8%
20/228 • Number of events 23 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.5%
12/218 • Number of events 20 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
7.5%
17/228 • Number of events 21 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.5%
12/218 • Number of events 16 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
3.5%
8/228 • Number of events 9 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.8%
6/218 • Number of events 8 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
5.3%
12/228 • Number of events 19 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
2.3%
5/218 • Number of events 7 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
5.3%
12/228 • Number of events 13 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Nervous system disorders
Headache
|
17.9%
39/218 • Number of events 68 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
17.5%
40/228 • Number of events 52 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Nervous system disorders
Dizziness
|
9.6%
21/218 • Number of events 28 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
10.5%
24/228 • Number of events 26 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Nervous system disorders
Neuropathy Peripheral
|
6.4%
14/218 • Number of events 17 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
7.0%
16/228 • Number of events 17 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Nervous system disorders
Paraesthesia
|
6.0%
13/218 • Number of events 15 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
3.9%
9/228 • Number of events 9 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
5.5%
12/218 • Number of events 15 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
11.0%
25/228 • Number of events 37 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Infections and infestations
Urinary Tract Infection
|
7.8%
17/218 • Number of events 20 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
9.2%
21/228 • Number of events 28 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.1%
9/218 • Number of events 12 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
8.3%
19/228 • Number of events 46 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
|
Infections and infestations
Paronychia
|
5.0%
11/218 • Number of events 15 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
6.6%
15/228 • Number of events 16 • Adverse events were recorded and reported during the study and up to two years after the last dose of the study drug was received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER