Trial Outcomes & Findings for A Study of the Safety of Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Early and Locally Advanced Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer (NCT NCT01940497)
NCT ID: NCT01940497
Last Updated: 2020-11-03
Results Overview
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were the AEs occurring from starting on the day of or after first administration of trastuzumab and within 28 days after last dose of trastuzumab. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
240 participants
Primary outcome timeframe
Day 1 up to 28 days after last dose of trastuzumab (up to approximately 1 year)
Results posted on
2020-11-03
Participant Flow
Out of 263 screened participants, 240 participants were enrolled in the study.
Participant milestones
| Measure |
Trastuzumab (Vial)
Participants received trastuzumab 600 milligrams (mg) subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID)
Participants received trastuzumab 600 mg subcutaneously using single-use injection device (SID) every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
119
|
|
Overall Study
Treated
|
115
|
113
|
|
Overall Study
Treated: Adjuvant
|
95
|
92
|
|
Overall Study
Treated: Neoadjuvant
|
20
|
21
|
|
Overall Study
COMPLETED
|
100
|
101
|
|
Overall Study
NOT COMPLETED
|
21
|
18
|
Reasons for withdrawal
| Measure |
Trastuzumab (Vial)
Participants received trastuzumab 600 milligrams (mg) subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID)
Participants received trastuzumab 600 mg subcutaneously using single-use injection device (SID) every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
|---|---|---|
|
Overall Study
Adverse Event/Intercurrent Illness
|
11
|
8
|
|
Overall Study
Recurrence of Disease Postsurgery
|
1
|
3
|
|
Overall Study
Violation of Entry Criteria
|
1
|
1
|
|
Overall Study
Refused Treatment
|
1
|
3
|
|
Overall Study
Withdrew Consent
|
6
|
2
|
|
Overall Study
Administrative/Other
|
1
|
1
|
Baseline Characteristics
A Study of the Safety of Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Early and Locally Advanced Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Trastuzumab (Vial)
n=121 Participants
Participants received trastuzumab 600 milligrams (mg) subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID)
n=119 Participants
Participants received trastuzumab 600 mg subcutaneously using single-use injection device (SID) every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant or neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 10.51 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 10.37 • n=7 Participants
|
54.2 years
STANDARD_DEVIATION 10.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 28 days after last dose of trastuzumab (up to approximately 1 year)Population: Safety population
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were the AEs occurring from starting on the day of or after first administration of trastuzumab and within 28 days after last dose of trastuzumab. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.
Outcome measures
| Measure |
Trastuzumab (Vial): Adjuvant
n=95 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (Vial): Neoadjuvant
n=20 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Adjuvant
n=92 Participants
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Neoadjuvant
n=21 Participants
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
|---|---|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
98.9 Percentage of Participants
|
100.0 Percentage of Participants
|
89.1 Percentage of Participants
|
95.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 1 up last dose of trastuzumab (up to approximately 1 year)Population: Safety Population
Actual dose (mg) administered = (sum over all cycles of actual dose received \[mg\] divided by number of cycles). Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.
Outcome measures
| Measure |
Trastuzumab (Vial): Adjuvant
n=95 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (Vial): Neoadjuvant
n=20 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Adjuvant
n=92 Participants
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Neoadjuvant
n=21 Participants
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
|---|---|---|---|---|
|
Actual Dose of Trastuzumab Administered
|
599.7 mg
Standard Deviation 3.08
|
600.00 mg
Standard Deviation 0.000
|
593.3 mg
Standard Deviation 16.55
|
595.9 mg
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Day 1 up last dose of trastuzumab (up to approximately 1 year)Population: Safety Population
Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.
Outcome measures
| Measure |
Trastuzumab (Vial): Adjuvant
n=95 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (Vial): Neoadjuvant
n=20 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Adjuvant
n=92 Participants
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Neoadjuvant
n=21 Participants
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
|---|---|---|---|---|
|
Duration of Treatment With Trastuzumab
|
346 days
Standard Deviation 72.13
|
352.2 days
Standard Deviation 55.82
|
340.1 days
Standard Deviation 85.47
|
351.9 days
Standard Deviation 90.02
|
SECONDARY outcome
Timeframe: Screening (Day -28 to -1) up to 2.5 yearsPopulation: Safety Population
Outcome measures
| Measure |
Trastuzumab (Vial): Adjuvant
n=115 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (Vial): Neoadjuvant
n=113 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Adjuvant
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Neoadjuvant
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
|---|---|---|---|---|
|
Percentage of Participants Who Received Concomitant Medications
|
100 Percentage of Participants
|
100 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to 24 weeksPopulation: Modified intent-to-treat (m-ITT) population included all enrolled participants satisfying criteria for eligibility.
In the neoadjuvant setting, the activity of two sequential drug regimens, doxorubicin-containing chemotherapy followed by paclitaxel or docetaxel chemotherapy in combination with trastuzumab, was assessed as the percentage of participants with pCR in breast and nodes using mammography. pCR was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after preoperative treatment. Data for this outcome measure were analyzed and reported only for neoadjuvant groups within each treatment arm.
Outcome measures
| Measure |
Trastuzumab (Vial): Adjuvant
n=22 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (Vial): Neoadjuvant
n=19 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Adjuvant
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Neoadjuvant
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
|---|---|---|---|---|
|
Percentage of Participants With Pathological Complete Response (pCR) (Neoadjuvant Groups Only) Using Mammography
|
40.9 Percentage of Participants
Interval 31.0 to 51.0
|
15.8 Percentage of Participants
Interval 8.0 to 24.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first [up to approximately 4.5 years])Population: m-ITT population. Here, 'Number of Participants Analyzed' = participants who were evaluable for this outcome measure.
A participant was considered as disease free if the participant was free from local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first). Percentage of participants with event at the cut off date were reported. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.
Outcome measures
| Measure |
Trastuzumab (Vial): Adjuvant
n=92 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (Vial): Neoadjuvant
n=18 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Adjuvant
n=91 Participants
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Neoadjuvant
n=18 Participants
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
|---|---|---|---|---|
|
Percentage of Participants With Event (Local, Regional or Distant Recurrence, Contralateral Breast Cancer or Death) Using Mammography
|
18.5 Percentage of Participants
|
33.3 Percentage of Participants
|
6.6 Percentage of Participants
|
11.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 1 up to local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first [up to approximately 4.5 years])Population: m-ITT population. Here, 'Number of Participants Analyzed' = participants who were evaluable for this outcome measure.
DFS was defined as the time from the first treatment to local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first). Kaplan-Meier estimates were used for analysis. Participants who were disease-free were censored at the data cut off date. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.
Outcome measures
| Measure |
Trastuzumab (Vial): Adjuvant
n=92 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (Vial): Neoadjuvant
n=18 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Adjuvant
n=91 Participants
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Neoadjuvant
n=18 Participants
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
|---|---|---|---|---|
|
Disease-Free Survival (DFS) Using Mammography
|
NA Months
Median and corresponding 95% confidence interval (CI) could not be estimated because majority of participants were censored at data cut off date.
|
NA Months
Median and corresponding 95% CI could not be estimated because majority of participants were censored at data cut off date.
|
NA Months
Median and corresponding 95% CI could not be estimated because majority of participants were censored at data cut off date.
|
NA Months
Median and corresponding 95% CI could not be estimated because majority of participants were censored at data cut off date.
|
SECONDARY outcome
Timeframe: Day 1 up to death due to any cause (up to approximately 4.5 years)Population: m-ITT population
Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.
Outcome measures
| Measure |
Trastuzumab (Vial): Adjuvant
n=96 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (Vial): Neoadjuvant
n=22 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Adjuvant
n=93 Participants
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Neoadjuvant
n=19 Participants
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
|---|---|---|---|---|
|
Percentage of Participants Who Died
|
5.2 Percentage of Participants
|
4.5 Percentage of Participants
|
0.0 Percentage of Participants
|
5.26 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 1 up to death due to any cause (up to approximately 4.5 years)Population: m-ITT population
Overall survival was defined as the time from the first treatment to death from any cause. Kaplan-Meier estimates were used for analysis. Participants who did not die were censored on the date they were last known to be alive. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.
Outcome measures
| Measure |
Trastuzumab (Vial): Adjuvant
n=96 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (Vial): Neoadjuvant
n=22 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Adjuvant
n=93 Participants
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Neoadjuvant
n=19 Participants
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
NA Months
Median and corresponding 95% CI could not be estimated because majority of participants were censored at data cut off date.
|
NA Months
Median and corresponding 95% CI could not be estimated because majority of participants were censored at data cut off date.
|
NA Months
Median and corresponding 95% CI could not be estimated because majority of participants were censored at data cut off date.
|
NA Months
Median and corresponding 95% CI could not be estimated because majority of participants were censored at data cut off date.
|
SECONDARY outcome
Timeframe: After at least 14 cycles (1 cycle = 21 days; maximum up to 1 year)Population: PSQ population included all enrolled participants from trastuzumab (SID) group who were able to use SID and had completed a minimum of 14 administrations of trastuzumab subcutaneously using SID (at least 10 of which were self-administered). Here, 'Number of Participants Analyzed' = participants who were evaluable for this outcome measure.
Participants were asked the following 5 questions: (1) "Following the first injection given by the physician/nurse and training on how to use the SID, I felt comfortable injecting the study drug by myself"; (2) "The SID was convenient and easy to use"; (3) "I am confident giving myself an injection in the thigh with the SID"; (4) "Taking all things into account, I find self-administration using the SID satisfactory"; (5) "If given the opportunity, I would choose to continue self-injecting the study drug using the SID at home". Response to each question was recorded as either of the following options: "Unknown", "Strongly Disagree", "Disagree", "Unsure", "Agree", "Strongly Agree". Percentage of participants who provided responses to above questions was reported. Data for this outcome measure were analyzed and reported only for Trastuzumab (SID) arm.
Outcome measures
| Measure |
Trastuzumab (Vial): Adjuvant
n=15 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (Vial): Neoadjuvant
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Adjuvant
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Neoadjuvant
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
|---|---|---|---|---|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Would continue: Unsure
|
6.7 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Would continue: Agree
|
20 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Would continue: Strongly Agree
|
60 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Would continue: Disagree
|
13.3 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Comfortable: Unknown
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Comfortable: Strongly Disagree
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Comfortable: Disagree
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Comfortable: Unsure
|
6.7 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Comfortable: Agree
|
40 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Comfortable: Strongly Agree
|
53.3 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Convenient: Unknown
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Convenient: Strongly Disagree
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Convenient: Disagree
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Convenient: Unsure
|
6.7 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Convenient: Agree
|
33.3 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Convenient: Strongly Agree
|
60 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Confident: Unknown
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Confident: Strongly Disagree
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Confident: Disagree
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Confident: Unsure
|
6.7 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Confident: Agree
|
40.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Confident: Strongly Agree
|
53.3 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Satisfactory: Unknown
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Satisfactory: Strongly Disagree
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Satisfactory: Disagree
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Satisfactory: Unsure
|
6.7 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Satisfactory: Agree
|
33.3 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Satisfactory: Strongly Agree
|
60 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Would continue: Unknown
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)
Would continue: Strongly Disagree
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After at least 4 participants completed 5 cycles of adjuvant treatment (1 cycle = 21 days; maximum up to 1 year)Population: HCPQ population included all investigators and study nurses who completed the questionnaire at each site when at least 4 participants from their site had received at least 5 cycles of adjuvant study treatment (52 and 50, respectively for Vial and SID groups).
Percentage of HCPs providing responses to various questions related to overall ease of study drug administration was reported in different categories, where categories indicate all possible responses to such questions.
Outcome measures
| Measure |
Trastuzumab (Vial): Adjuvant
n=52 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (Vial): Neoadjuvant
n=50 Participants
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Adjuvant
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID): Neoadjuvant
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
|---|---|---|---|---|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Specialization: Oncologist
|
17.3 Percentage of HCPs
|
16.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Specialization: Specialist nurse
|
69.2 Percentage of HCPs
|
76.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Specialization: Other
|
11.5 Percentage of HCPs
|
8.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Specialization: Missing
|
1.9 Percentage of HCPs
|
0.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Personally administered/supervised: Always
|
40.4 Percentage of HCPs
|
48.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Personally administered/supervised: Sometimes
|
51.9 Percentage of HCPs
|
48.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Personally administered/supervised: Never
|
7.7 Percentage of HCPs
|
4.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
If 'Never', who administered: Specialist nurse
|
7.7 Percentage of HCPs
|
4.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Syringe prepared at: Pharmacy
|
55.8 Percentage of HCPs
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to vial group.
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Syringe prepared at: Oncology ward
|
40.4 Percentage of HCPs
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to vial group.
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Syringe prepared at: Missing
|
3.8 Percentage of HCPs
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to vial group.
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Time to fill syringe: less than (<) 5 minutes
|
67.3 Percentage of HCPs
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to vial group.
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Time to fill syringe: 6-10 minutes
|
13.5 Percentage of HCPs
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to vial group.
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Time to fill syringe: 11-15 minutes
|
5.8 Percentage of HCPs
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to vial group.
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Time to fill syringe: Unknown
|
13.5 Percentage of HCPs
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to vial group.
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Total time for vial administration: <3 minutes
|
1.9 Percentage of HCPs
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to vial group.
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Total time for vial administration: <5 minutes
|
59.6 Percentage of HCPs
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to vial group.
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Total time for vial administration: 6-15 minutes
|
38.5 Percentage of HCPs
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to vial group.
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Time to prepare SID: <5 minutes
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to SID group.
|
72.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Time to prepare SID: 6-10 minutes
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to SID group.
|
14.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Time to prepare SID: 11-15 minutes
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to SID group.
|
4.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Time to prepare SID: 16-20 minutes
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to SID group.
|
2.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Time to prepare SID: >20 minutes
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to SID group.
|
8.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Total time for SID administration: <3 minutes
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to SID group.
|
26.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Total time for SID administration: <5 minutes
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to SID group.
|
30.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Total time for SID administration: 6-15 minutes
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to SID group.
|
44.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Injection site: Irritation: A lot
|
1.9 Percentage of HCPs
|
4.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Injection site: Irritation: A few
|
46.2 Percentage of HCPs
|
36.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Injection site: Irritation: None
|
51.9 Percentage of HCPs
|
60.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Injection site: Bruising: A few
|
7.7 Percentage of HCPs
|
10.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Injection site: Bruising: None
|
92.3 Percentage of HCPs
|
90.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Injection site: Infection: None
|
100.0 Percentage of HCPs
|
100.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Fever,shivering,flu-like,rash,swelling:A few
|
15.4 Percentage of HCPs
|
14.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Fever,shivering,flu-like,rash,swelling:None
|
84.6 Percentage of HCPs
|
86.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Time at hospital for administration: <2 hours
|
44.2 Percentage of HCPs
|
44.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Time at hospital for administration: >2, <3 hours
|
23.1 Percentage of HCPs
|
34.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Time at hospital for administration: >3, <4 hours
|
23.1 Percentage of HCPs
|
12.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Time at hospital for administration: >4 hours
|
7.7 Percentage of HCPs
|
10.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Time at hospital for administration: Missing
|
1.9 Percentage of HCPs
|
0.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Anxiety to participants: None
|
82.7 Percentage of HCPs
|
90.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Anxiety to participants: A fair amount
|
17.3 Percentage of HCPs
|
10.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Ease of vial administration: None
|
5.8 Percentage of HCPs
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to vial group.
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Ease of vial administration: A fair amount
|
38.5 Percentage of HCPs
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to vial group.
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Ease of vial administration: A lot
|
55.8 Percentage of HCPs
|
NA Percentage of HCPs
Data were not evaluable as this question applied only to vial group.
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Subcutaneous route may simplify management: Yes
|
94.2 Percentage of HCPs
|
100.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Subcutaneous route may simplify management: No
|
5.8 Percentage of HCPs
|
0.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Would recommend SID to intravenous route: Yes
|
96.2 Percentage of HCPs
|
96.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Would recommend SID to intravenous route: No
|
3.8 Percentage of HCPs
|
4.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Would recommend subcutaneous route to medics: Yes
|
100.0 Percentage of HCPs
|
90.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Would recommend subcutaneous route to medics: No
|
0.0 Percentage of HCPs
|
8.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Would recommend subcutaneous to medics:Missing
|
0.0 Percentage of HCPs
|
2.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Convenience of using SID by participants: Yes
|
94.2 Percentage of HCPs
|
96.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Convenience of using SID by participants: No
|
0.0 Percentage of HCPs
|
4.0 Percentage of HCPs
|
—
|
—
|
|
Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)
Convenience of using SID by participants: Missing
|
5.8 Percentage of HCPs
|
0.0 Percentage of HCPs
|
—
|
—
|
Adverse Events
Trastuzumab (Vial): Adjuvant
Serious events: 5 serious events
Other events: 92 other events
Deaths: 5 deaths
Trastuzumab (Vial): Neoadjuvant
Serious events: 3 serious events
Other events: 20 other events
Deaths: 1 deaths
Trastuzumab (SID) Adjuvant
Serious events: 7 serious events
Other events: 79 other events
Deaths: 0 deaths
Trastuzumab (SID) Neoadjuvant
Serious events: 2 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Trastuzumab (Vial): Adjuvant
n=95 participants at risk
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (Vial): Neoadjuvant
n=20 participants at risk
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID) Adjuvant
n=92 participants at risk
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID) Neoadjuvant
n=21 participants at risk
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
1.1%
1/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Cardiac disorders
Pleuropericarditis
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
General disorders
Pryexia
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
1.1%
1/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Immune system disorders
Anaphylactic shock
|
1.1%
1/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
1.1%
1/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
1.1%
1/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
1.1%
1/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
1.1%
1/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
1.1%
1/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer metastatic
|
1.1%
1/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Nervous system disorders
Syncope
|
1.1%
1/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
1.1%
1/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
1.1%
1/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
1.1%
1/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
Other adverse events
| Measure |
Trastuzumab (Vial): Adjuvant
n=95 participants at risk
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (Vial): Neoadjuvant
n=20 participants at risk
Participants received trastuzumab 600 mg subcutaneously using a vial every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID) Adjuvant
n=92 participants at risk
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with adjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
Trastuzumab (SID) Neoadjuvant
n=21 participants at risk
Participants received trastuzumab 600 mg subcutaneously using SID every 3 weeks (1 cycle) for 1 year (4 cycles in combination with neoadjuvant chemotherapy \[consisting of doxorubicin, paclitaxel or docetaxel\] and 14 cycles administered alone).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
21.1%
20/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
20.0%
4/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.3%
4/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Blood and lymphatic system disorders
Anaemia
|
15.8%
15/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
10.0%
2/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
7.6%
7/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
19.0%
4/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.5%
10/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
15.0%
3/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.4%
5/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Gastrointestinal disorders
Diarrhoea
|
26.3%
25/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
15.0%
3/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
16.3%
15/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
28.6%
6/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Gastrointestinal disorders
Nausea
|
8.4%
8/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
10.0%
2/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
14.1%
13/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
14.3%
3/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Gastrointestinal disorders
Stomatitis
|
6.3%
6/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
15.0%
3/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
7.6%
7/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
14.3%
3/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.4%
8/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.4%
5/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Gastrointestinal disorders
Constipation
|
8.4%
8/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
7.6%
7/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
7/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.4%
5/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
9.5%
2/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Gastrointestinal disorders
Abdominal pain
|
6.3%
6/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
3.3%
3/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Gastrointestinal disorders
Dyspepsia
|
6.3%
6/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.3%
4/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
General disorders
Asthenia
|
33.7%
32/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
15.0%
3/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
21.7%
20/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
33.3%
7/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
General disorders
Pyrexia
|
18.9%
18/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
20.0%
4/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
14.1%
13/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
19.0%
4/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
General disorders
Fatigue
|
12.6%
12/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
13.0%
12/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
General disorders
Oedema peripheral
|
10.5%
10/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
12.0%
11/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
General disorders
Mucosal inflammation
|
9.5%
9/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
7.6%
7/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
General disorders
Chest pain
|
6.3%
6/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
General disorders
Pain
|
7.4%
7/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
3.3%
3/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
General disorders
Influenza like illness
|
5.3%
5/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
2.2%
2/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
General disorders
Oedema
|
6.3%
6/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
2.2%
2/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Infections and infestations
Cystitis
|
7.4%
7/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
8.7%
8/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Infections and infestations
Influenza
|
3.2%
3/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
9.8%
9/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
14.3%
3/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Investigations
Ejection fraction decreased
|
13.7%
13/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
10.0%
2/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
3.3%
3/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
14.3%
3/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Investigations
Neutrophil count decreased
|
3.2%
3/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
6.5%
6/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
9.5%
2/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Investigations
White blood cell count decreased
|
2.1%
2/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.4%
5/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.1%
2/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.4%
5/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.5%
29/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
20.0%
4/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
30.4%
28/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
23.8%
5/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.7%
13/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
8.7%
8/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
9.5%
2/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.5%
9/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
10.0%
2/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
6.5%
6/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.5%
9/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.3%
4/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.3%
6/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
8.7%
8/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Nervous system disorders
Paraesthesia
|
51.6%
49/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
15.0%
3/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
27.2%
25/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
14.3%
3/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Nervous system disorders
Headache
|
6.3%
6/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
10.0%
2/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.3%
4/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Nervous system disorders
Dysgeusia
|
6.3%
6/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
6.5%
6/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Nervous system disorders
Neurotoxicity
|
3.2%
3/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
15.0%
3/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.4%
5/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Reproductive system and breast disorders
Amenorrhoea
|
4.2%
4/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
3.3%
3/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
9.5%
2/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.6%
12/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
15.0%
3/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
16.3%
15/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.7%
14/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
8.7%
8/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
9.5%
2/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Skin and subcutaneous tissue disorders
Erythema
|
24.2%
23/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
10.0%
2/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
15.2%
14/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
9.5%
2/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
11.6%
11/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
10.0%
2/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
9.8%
9/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
7.4%
7/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
1.1%
1/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
7/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
6.5%
6/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.2%
4/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
10.0%
2/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
7.6%
7/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Vascular disorders
Hot flush
|
7.4%
7/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
25.0%
5/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
7.6%
7/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
9.5%
2/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Vascular disorders
Hypertension
|
7.4%
7/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
25.0%
5/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
8.7%
8/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Vascular disorders
Lymphoedema
|
5.3%
5/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
1.1%
1/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
10.0%
2/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
2.2%
2/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Cardiac disorders
Tachycardia
|
6.3%
6/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
1.1%
1/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
9.5%
2/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Eye disorders
Eye disorder
|
1.1%
1/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.1%
2/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.4%
5/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
General disorders
Injection site erythema
|
1.1%
1/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
1.1%
1/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
General disorders
Peripheral swelling
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
2.2%
2/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Immune system disorders
Hypersensitivity
|
3.2%
3/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
10.0%
2/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Infections and infestations
Conjunctivitis
|
3.2%
3/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
10.0%
2/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
2.2%
2/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
9.5%
2/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Infections and infestations
Pharyngitis
|
3.2%
3/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
10.0%
2/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.3%
4/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Infections and infestations
Mastitis
|
2.1%
2/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
1.1%
1/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
1.1%
1/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
10.0%
2/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
2.2%
2/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
3/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
1.1%
1/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
14.3%
3/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
1/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
9.5%
2/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Investigations
Blood pressure increased
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Investigations
Hepatic enzyme abnormal
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Investigations
Hepatitis C virus test positive
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Investigations
Transaminases increased
|
2.1%
2/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
3.3%
3/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
9.5%
2/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.2%
4/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.4%
5/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
3.2%
3/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
2.2%
2/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
5.3%
5/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
3.3%
3/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Nervous system disorders
Dizziness
|
5.3%
5/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
1.1%
1/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Nervous system disorders
Sciatica
|
5.3%
5/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
1.1%
1/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Nervous system disorders
Neuropathy peripheral
|
5.3%
5/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
2.2%
2/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.1%
1/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Nervous system disorders
Presyncope
|
2.1%
2/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
1.1%
1/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Psychiatric disorders
Anxiety
|
3.2%
3/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
10.0%
2/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.4%
5/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Renal and urinary disorders
Dysuria
|
3.2%
3/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.3%
4/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Psychiatric disorders
Panic attack
|
1.1%
1/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
5/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.3%
4/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
4.8%
1/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.2%
3/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
1.1%
1/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
5.0%
1/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
1.1%
1/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.1%
1/95 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
10.0%
2/20 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
2.2%
2/92 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
0.00%
0/21 • Day 1 up to 28 days after last dose of trastuzumab
Safety population TEAEs
|
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