Trial Outcomes & Findings for Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer (NCT NCT01401166)
NCT ID: NCT01401166
Last Updated: 2017-03-06
Results Overview
The preferred method of drug administration (IV or SC Herceptin) was assessed in trial-specific telephone interviews with each study participant. Participants were asked, "All things considered, which method of administration did you prefer?" at the end of the crossover period (Week 24). The percentage of participants who preferred each method of drug administration was reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
488 participants
Primary outcome timeframe
Week 24
Results posted on
2017-03-06
Participant Flow
A total of 248 participants were randomized into the study in Cohort 1 (of whom 244 were treated) and 240 participants were randomized into the study in Cohort 2 (of whom 239 were treated). Those participants who did not receive any treatment were not included in the treatment periods of the Participant Flow.
Participant milestones
| Measure |
Cohort 1: SC (SID) Then IV Herceptin
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via single-use injection device (SID), and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by healthcare professional (HCP). Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 milligrams (mg) for all cycles where SC Herceptin was given, and the IV dose was 6 milligrams per kilogram (mg/kg) for all cycles where IV Herceptin was given.
|
Cohort 1: IV Then SC (SID) Herceptin
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
Cohort 2: SC (Vial) Then IV Herceptin
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
|
Cohort 2: IV Then SC (Vial) Herceptin
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
|---|---|---|---|---|
|
Crossover Treatment 1 (Cycles 1 to 4)
STARTED
|
122
|
122
|
121
|
118
|
|
Crossover Treatment 1 (Cycles 1 to 4)
COMPLETED
|
119
|
120
|
119
|
116
|
|
Crossover Treatment 1 (Cycles 1 to 4)
NOT COMPLETED
|
3
|
2
|
2
|
2
|
|
Crossover Treatment 2 (Cycles 5 to 8)
STARTED
|
119
|
120
|
119
|
116
|
|
Crossover Treatment 2 (Cycles 5 to 8)
COMPLETED
|
113
|
116
|
107
|
105
|
|
Crossover Treatment 2 (Cycles 5 to 8)
NOT COMPLETED
|
6
|
4
|
12
|
11
|
|
Continuation Treatment (Cycles 9 to 18)
STARTED
|
113
|
116
|
107
|
105
|
|
Continuation Treatment (Cycles 9 to 18)
COMPLETED
|
109
|
109
|
105
|
102
|
|
Continuation Treatment (Cycles 9 to 18)
NOT COMPLETED
|
4
|
7
|
2
|
3
|
|
Safety Follow-Up Period
STARTED
|
124
|
124
|
121
|
119
|
|
Safety Follow-Up Period
COMPLETED
|
99
|
106
|
104
|
100
|
|
Safety Follow-Up Period
NOT COMPLETED
|
25
|
18
|
17
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1 Overall: SC (SID) and IV Herceptin
n=244 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
Cohort 2 Overall: SC (Vial) and IV Herceptin
n=239 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via handheld syringe using the vial formulation for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received SC Herceptin for up to 10 remaining cycles. Administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
Total
n=483 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 11.40 • n=5 Participants
|
52.9 years
STANDARD_DEVIATION 10.87 • n=7 Participants
|
53.1 years
STANDARD_DEVIATION 11.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
244 Participants
n=5 Participants
|
239 Participants
n=7 Participants
|
483 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Intent-to-Treat (ITT) Population: All participants who received both IV and SC Herceptin and who completed the trial-specific telephone interview conducted after the end of the crossover period.
The preferred method of drug administration (IV or SC Herceptin) was assessed in trial-specific telephone interviews with each study participant. Participants were asked, "All things considered, which method of administration did you prefer?" at the end of the crossover period (Week 24). The percentage of participants who preferred each method of drug administration was reported.
Outcome measures
| Measure |
Cohort 1: SC (SID) Then IV Herceptin
n=117 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
|
Cohort 1: IV Then SC (SID) Herceptin
n=119 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
Cohort 2: SC (Vial) Then IV Herceptin
n=118 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
|
Cohort 2: IV Then SC (Vial) Herceptin
n=113 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
|---|---|---|---|---|
|
Percentage of Participants by Preferred Method of Drug Administration
SC Herceptin
|
95.7 percentage of participants
|
87.4 percentage of participants
|
83.9 percentage of participants
|
88.5 percentage of participants
|
|
Percentage of Participants by Preferred Method of Drug Administration
IV Herceptin
|
4.3 percentage of participants
|
9.2 percentage of participants
|
13.6 percentage of participants
|
11.5 percentage of participants
|
|
Percentage of Participants by Preferred Method of Drug Administration
No Preference
|
0.0 percentage of participants
|
3.4 percentage of participants
|
2.5 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: HCP Population: All HCPs who participated in the study and completed the HCP questionnaire. Results were planned to be analyzed for all HCPs combined because the objective of the study was to compare preference between SC and IV Herceptin.
The method of drug administration with which HCPs were most satisfied (IV or SC Herceptin) was assessed via questionnaire with each HCP using the question, "All things considered, with which method of administration were you most satisfied?" at the end of the crossover period (Week 24). The percentage of HCPs who were most satisfied with each method of drug administration was reported.
Outcome measures
| Measure |
Cohort 1: SC (SID) Then IV Herceptin
n=235 HCPs
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
|
Cohort 1: IV Then SC (SID) Herceptin
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
Cohort 2: SC (Vial) Then IV Herceptin
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
|
Cohort 2: IV Then SC (Vial) Herceptin
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
|---|---|---|---|---|
|
Percentage of HCPs by Most Satisfied Method of Drug Administration
SC Herceptin
|
77.0 percentage of HCPs
|
—
|
—
|
—
|
|
Percentage of HCPs by Most Satisfied Method of Drug Administration
IV Herceptin
|
3.0 percentage of HCPs
|
—
|
—
|
—
|
|
Percentage of HCPs by Most Satisfied Method of Drug Administration
No Preference
|
20.0 percentage of HCPs
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: HCP Population. Results were planned to be analyzed for all HCPs combined because the objective of the study was to compare HCP perceived time savings with use of SC over IV Herceptin.
The time required to perform each method of drug administration was assessed via questionnaire with each HCP by asking to rate the amount of time it took to administer each method of drug administration (IV or SC Herceptin) at the end of the crossover period (Week 24). Time was rated in the following time block categories: less than (\<) 5 minutes, 6 to 10 minutes, 11 to 15 minutes, 16 to 20 minutes, and greater than (\>) 20 minutes. Responses of "Not Sure" and "Unknown" were also allowed. The percentage of HCPs who rated the amount of time in each of the categories was reported.
Outcome measures
| Measure |
Cohort 1: SC (SID) Then IV Herceptin
n=235 HCPs
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
|
Cohort 1: IV Then SC (SID) Herceptin
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
Cohort 2: SC (Vial) Then IV Herceptin
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
|
Cohort 2: IV Then SC (Vial) Herceptin
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
|---|---|---|---|---|
|
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
SC Herceptin, <5 minutes
|
44.3 percentage of HCPs
|
—
|
—
|
—
|
|
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
SC Herceptin, 6 to 10 minutes
|
46.4 percentage of HCPs
|
—
|
—
|
—
|
|
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
SC Herceptin, 11 to 15 minutes
|
3.4 percentage of HCPs
|
—
|
—
|
—
|
|
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
SC Herceptin, 16 to 20 minutes
|
0.4 percentage of HCPs
|
—
|
—
|
—
|
|
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
SC Herceptin, >20 minutes
|
0.4 percentage of HCPs
|
—
|
—
|
—
|
|
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
SC Herceptin, Not Sure
|
0.0 percentage of HCPs
|
—
|
—
|
—
|
|
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
SC Herceptin, Unknown
|
5.1 percentage of HCPs
|
—
|
—
|
—
|
|
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
IV Herceptin, <5 minutes
|
11.1 percentage of HCPs
|
—
|
—
|
—
|
|
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
IV Herceptin, 6 to 10 minutes
|
9.8 percentage of HCPs
|
—
|
—
|
—
|
|
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
IV Herceptin, 11 to 15 minutes
|
3.8 percentage of HCPs
|
—
|
—
|
—
|
|
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
IV Herceptin, 16 to 20 minutes
|
44.3 percentage of HCPs
|
—
|
—
|
—
|
|
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
IV Herceptin, >20 minutes
|
22.1 percentage of HCPs
|
—
|
—
|
—
|
|
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
IV Herceptin, Not Sure
|
5.1 percentage of HCPs
|
—
|
—
|
—
|
|
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
IV Herceptin, Unknown
|
3.8 percentage of HCPs
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)Population: ITT Population
EFS events included local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The percentage of participants who had an EFS event at any time on study was reported.
Outcome measures
| Measure |
Cohort 1: SC (SID) Then IV Herceptin
n=117 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
|
Cohort 1: IV Then SC (SID) Herceptin
n=119 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
Cohort 2: SC (Vial) Then IV Herceptin
n=118 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
|
Cohort 2: IV Then SC (Vial) Herceptin
n=113 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
|---|---|---|---|---|
|
Percentage of Participants With an Event-Free Survival (EFS) Event
|
13.7 percentage of participants
|
6.7 percentage of participants
|
11.9 percentage of participants
|
7.1 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)Population: ITT Population
EFS was defined as the time from randomization to a local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The median duration of EFS and corresponding 95 percent (%) CI according to Kaplan-Meier estimates were planned to be reported and expressed in months.
Outcome measures
| Measure |
Cohort 1: SC (SID) Then IV Herceptin
n=117 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
|
Cohort 1: IV Then SC (SID) Herceptin
n=119 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
Cohort 2: SC (Vial) Then IV Herceptin
n=118 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
|
Cohort 2: IV Then SC (Vial) Herceptin
n=113 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
|---|---|---|---|---|
|
Duration of EFS According to Kaplan-Meier Estimate
|
NA months
Median and 95% CI not presented due to insufficient follow-up to allow estimation.
|
NA months
Interval 42.0 to
Median and 95% CI not presented due to insufficient follow-up to allow estimation.
|
NA months
Median and 95% CI not presented due to insufficient follow-up to allow estimation.
|
NA months
Median and 95% CI not presented due to insufficient follow-up to allow estimation.
|
SECONDARY outcome
Timeframe: Year 3Population: ITT Population
EFS events included local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The proportion of participants without an EFS event (i.e., the EFS rate) and corresponding 95% CI at 3 years after randomization was reported.
Outcome measures
| Measure |
Cohort 1: SC (SID) Then IV Herceptin
n=117 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
|
Cohort 1: IV Then SC (SID) Herceptin
n=119 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
Cohort 2: SC (Vial) Then IV Herceptin
n=118 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
|
Cohort 2: IV Then SC (Vial) Herceptin
n=113 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
|---|---|---|---|---|
|
3-Year EFS Rate
|
0.849 proportion of participants
Interval 0.763 to 0.906
|
0.948 proportion of participants
Interval 0.887 to 0.976
|
0.886 proportion of participants
Interval 0.811 to 0.932
|
0.937 proportion of participants
Interval 0.873 to 0.97
|
SECONDARY outcome
Timeframe: Immediately following first self-administration of SC Herceptin via SID (once during Weeks 25 to 52)Population: Safety Population. The "Number of Participants Analyzed" reflects those who self-administered SC Herceptin using the SID and completed the SC SID questionnaire. Results were planned to be analyzed for only Cohort 1 because the objective of the study was to evaluate satisfaction among those who self-administered the SID formulation of Herceptin.
Participants who performed self-administration of SC Herceptin via SID were given an evaluation questionnaire during the continuation period (Weeks 25 to 52) after their first self-administration. Participants responded to 5 statements about their comfort with self-injection, the convenience of the SID, their self-confidence using the SID, their satisfaction with the SID, and whether they would consider using the SID again in the future. Each statement used a 5-item rating scale with responses from "Strongly Disagree" to "Strongly Agree". The percentage of participants with a positive response (either "Agree" or "Strongly Agree") to each questionnaire statement was reported.
Outcome measures
| Measure |
Cohort 1: SC (SID) Then IV Herceptin
n=19 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
|
Cohort 1: IV Then SC (SID) Herceptin
n=15 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
Cohort 2: SC (Vial) Then IV Herceptin
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
|
Cohort 2: IV Then SC (Vial) Herceptin
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
|---|---|---|---|---|
|
Percentage of Participants With Responses of "Agree" or "Strongly Agree" on the SC SID Satisfaction Questionnaire
Comfortable
|
94.7 percentage of participants
|
86.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Responses of "Agree" or "Strongly Agree" on the SC SID Satisfaction Questionnaire
Convenient
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Responses of "Agree" or "Strongly Agree" on the SC SID Satisfaction Questionnaire
Confident
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Responses of "Agree" or "Strongly Agree" on the SC SID Satisfaction Questionnaire
Satisfied
|
100 percentage of participants
|
93.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Responses of "Agree" or "Strongly Agree" on the SC SID Satisfaction Questionnaire
Would Use Again
|
100 percentage of participants
|
93.3 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, pre-dose (0 hours) during Cycle 5 (cycle length of 3 weeks)Population: Safety Population. Results were planned to be analyzed for only Cohort 1 because the objective of the study was to evaluate immunogenicity within participants who received the SID formulation of Herceptin. The number of participants who provided ADA samples at each timepoint (n) is shown in the table.
Participants in Cohort 1 provided blood samples for immunogenicity testing to assess for anti-drug antibodies (ADAs) to trastuzumab or rHuPH20, a component of the SC Herceptin formulation. The percentage of participants who were trastuzumab ADA-positive and the percentage of participants who were rHuPH20 ADA-positive were each reported.
Outcome measures
| Measure |
Cohort 1: SC (SID) Then IV Herceptin
n=122 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
|
Cohort 1: IV Then SC (SID) Herceptin
n=122 Participants
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
Cohort 2: SC (Vial) Then IV Herceptin
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
|
Cohort 2: IV Then SC (Vial) Herceptin
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
|---|---|---|---|---|
|
Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies
Trastuzumab ADA-Positive, Baseline (n=120,121)
|
2.5 percentage of participants
|
4.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies
Trastuzumab ADA-Positive, Cycle 5 (n=114,119)
|
0 percentage of participants
|
3.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies
rHuPH20 ADA-Positive, Baseline (n=120,121)
|
5.8 percentage of participants
|
7.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies
rHuPH20 ADA-Positive, Cycle 5 (n=115,119)
|
2.6 percentage of participants
|
7.6 percentage of participants
|
—
|
—
|
Adverse Events
Cohort 1: SC (SID) Herceptin (Crossover)
Serious events: 4 serious events
Other events: 81 other events
Deaths: 0 deaths
Cohort 1: IV Herceptin (Crossover)
Serious events: 2 serious events
Other events: 55 other events
Deaths: 0 deaths
Cohort 1: IV Herceptin (Continuation)
Serious events: 6 serious events
Other events: 46 other events
Deaths: 0 deaths
Cohort 1: SC (SID) Herceptin (Continuation)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 1 Overall: SC (SID) and IV Herceptin
Serious events: 12 serious events
Other events: 130 other events
Deaths: 0 deaths
Cohort 2: SC (Vial) Herceptin (Crossover)
Serious events: 0 serious events
Other events: 107 other events
Deaths: 0 deaths
Cohort 2: IV Herceptin (Crossover)
Serious events: 2 serious events
Other events: 76 other events
Deaths: 0 deaths
Cohort 2: IV Herceptin (Continuation)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2: SC (Vial) Herceptin (Continuation)
Serious events: 5 serious events
Other events: 61 other events
Deaths: 0 deaths
Cohort 2 Overall: SC (Vial) and IV Herceptin
Serious events: 7 serious events
Other events: 154 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: SC (SID) Herceptin (Crossover)
n=242 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. SC Herceptin was administered via SID as a 600-mg dose during four consecutive cycles of the crossover period. Administration was performed by HCP.
|
Cohort 1: IV Herceptin (Crossover)
n=241 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. IV Herceptin was given as a 6-mg/kg dose during four consecutive cycles of the crossover period. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg (instead of 6 mg/kg) for de novo participants who started Herceptin treatment in the study. Administration was performed by HCP.
|
Cohort 1: IV Herceptin (Continuation)
n=226 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants received IV Herceptin as a 6-mg/kg dose for up to 10 remaining cycles. Administration was performed by HCP.
|
Cohort 1: SC (SID) Herceptin (Continuation)
n=43 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID as a 600-mg dose under the direction of a trained HCP.
|
Cohort 1 Overall: SC (SID) and IV Herceptin
n=244 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
Cohort 2: SC (Vial) Herceptin (Crossover)
n=237 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. SC Herceptin was administered via handheld syringe using the vial formulation as a 600-mg dose during four consecutive cycles of the crossover period. Administration was performed by HCP.
|
Cohort 2: IV Herceptin (Crossover)
n=237 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. IV Herceptin was given as a 6-mg/kg dose during four consecutive cycles of the crossover period. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg (instead of 6 mg/kg) for de novo participants who started Herceptin treatment in the study. Administration was performed by HCP.
|
Cohort 2: IV Herceptin (Continuation)
n=10 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants were planned to receive SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. However, under protocol deviation a small number of participants received IV Herceptin as a 6-mg/kg dose for this period. Administration was performed by HCP.
|
Cohort 2: SC (Vial) Herceptin (Continuation)
n=208 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP.
|
Cohort 2 Overall: SC (Vial) and IV Herceptin
n=239 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via handheld syringe using the vial formulation for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received SC Herceptin for up to 10 remaining cycles. Administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Breast abscess
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.44%
1/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.41%
1/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Infections and infestations
Device related infection
|
0.41%
1/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.41%
1/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Infections and infestations
Influenza
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.41%
1/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.41%
1/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.44%
1/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.41%
1/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.44%
1/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.41%
1/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Infections and infestations
Subcutaneous abscess
|
0.41%
1/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.41%
1/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
General disorders
Adverse drug reaction
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.44%
1/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.41%
1/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
General disorders
Chest pain
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.44%
1/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.41%
1/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.41%
1/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.41%
1/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebral haemangioma
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.3%
1/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.41%
1/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Nervous system disorders
Dizziness
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.44%
1/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.41%
1/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.41%
1/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.41%
1/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Reproductive system and breast disorders
Endometrial hypertrophy
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.44%
1/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.41%
1/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Vascular disorders
Haematoma
|
0.41%
1/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.41%
1/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Surgical and medical procedures
Breast reconstruction
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.48%
1/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.42%
1/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.48%
1/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.42%
1/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Surgical and medical procedures
Mammoplasty
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.48%
1/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.42%
1/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Infections and infestations
Wound infection
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.42%
1/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.48%
1/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.84%
2/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.48%
1/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.42%
1/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.42%
1/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.42%
1/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.42%
1/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.42%
1/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
Other adverse events
| Measure |
Cohort 1: SC (SID) Herceptin (Crossover)
n=242 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. SC Herceptin was administered via SID as a 600-mg dose during four consecutive cycles of the crossover period. Administration was performed by HCP.
|
Cohort 1: IV Herceptin (Crossover)
n=241 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. IV Herceptin was given as a 6-mg/kg dose during four consecutive cycles of the crossover period. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg (instead of 6 mg/kg) for de novo participants who started Herceptin treatment in the study. Administration was performed by HCP.
|
Cohort 1: IV Herceptin (Continuation)
n=226 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants received IV Herceptin as a 6-mg/kg dose for up to 10 remaining cycles. Administration was performed by HCP.
|
Cohort 1: SC (SID) Herceptin (Continuation)
n=43 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID as a 600-mg dose under the direction of a trained HCP.
|
Cohort 1 Overall: SC (SID) and IV Herceptin
n=244 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
Cohort 2: SC (Vial) Herceptin (Crossover)
n=237 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. SC Herceptin was administered via handheld syringe using the vial formulation as a 600-mg dose during four consecutive cycles of the crossover period. Administration was performed by HCP.
|
Cohort 2: IV Herceptin (Crossover)
n=237 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. IV Herceptin was given as a 6-mg/kg dose during four consecutive cycles of the crossover period. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg (instead of 6 mg/kg) for de novo participants who started Herceptin treatment in the study. Administration was performed by HCP.
|
Cohort 2: IV Herceptin (Continuation)
n=10 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants were planned to receive SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. However, under protocol deviation a small number of participants received IV Herceptin as a 6-mg/kg dose for this period. Administration was performed by HCP.
|
Cohort 2: SC (Vial) Herceptin (Continuation)
n=208 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP.
|
Cohort 2 Overall: SC (Vial) and IV Herceptin
n=239 participants at risk
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via handheld syringe using the vial formulation for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received SC Herceptin for up to 10 remaining cycles. Administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Asthenia
|
5.4%
13/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
4.1%
10/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
4.0%
9/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
12.3%
30/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
7.2%
17/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
6.3%
15/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
5.3%
11/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
15.1%
36/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
General disorders
Fatigue
|
3.3%
8/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
4.1%
10/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
3.1%
7/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
9.4%
23/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
4.6%
11/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
3.4%
8/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
10.0%
1/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.4%
5/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
8.8%
21/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
General disorders
Injection site reaction
|
7.9%
19/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
7.8%
19/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
General disorders
Injection site erythema
|
5.4%
13/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
5.3%
13/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
6.3%
15/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
1.9%
4/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
7.1%
17/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
General disorders
Injection site pain
|
5.0%
12/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
4.7%
2/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
5.3%
13/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
8.4%
20/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.9%
6/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
10.0%
24/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.1%
10/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
6.2%
15/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
5.3%
12/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.3%
1/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
13.5%
33/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
6.3%
15/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
5.1%
12/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
4.8%
10/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
13.8%
33/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Vascular disorders
Hot flush
|
3.3%
8/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.5%
6/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
1.3%
3/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.3%
1/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
7.4%
18/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
5.9%
14/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
4.6%
11/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.4%
5/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
11.3%
27/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Vascular disorders
Hypertension
|
2.9%
7/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.41%
1/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.2%
5/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.3%
1/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
5.3%
13/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Gastrointestinal disorders
Nausea
|
5.8%
14/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.5%
6/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.7%
6/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.3%
1/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
9.0%
22/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
4.6%
11/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
3.4%
8/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
1.4%
3/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
7.1%
17/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Nervous system disorders
Headache
|
3.3%
8/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.5%
6/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
4.4%
10/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
8.6%
21/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
5.1%
12/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
4.6%
11/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
5.3%
11/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
12.1%
29/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
5/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.9%
7/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.2%
5/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.3%
1/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
6.6%
16/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.5%
6/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
1.3%
3/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
10.0%
1/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.9%
6/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
5.4%
13/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
General disorders
Chest pain
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
1.3%
3/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.84%
2/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
10.0%
1/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.5%
6/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
General disorders
Medical device discomfort
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
10.0%
1/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.42%
1/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
6.3%
15/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.1%
5/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.96%
2/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
7.9%
19/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.84%
2/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
1.3%
3/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
10.0%
1/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
1.9%
4/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
4.2%
10/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
1.3%
3/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
1.7%
4/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
10.0%
1/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.48%
1/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.9%
7/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.42%
1/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.42%
1/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
10.0%
1/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
1.9%
4/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.9%
7/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.1%
5/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
3.0%
7/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.96%
2/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
5.4%
13/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Vascular disorders
Thrombosis
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.84%
2/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
10.0%
1/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.84%
2/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Nervous system disorders
Dizziness
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
3.0%
7/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.84%
2/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
10.0%
1/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.48%
1/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
4.6%
11/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
3.4%
8/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
3.8%
9/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
4.3%
9/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
9.6%
23/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.42%
1/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.84%
2/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
10.0%
1/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
1.3%
3/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
6.3%
15/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
1.3%
3/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.9%
6/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
8.4%
20/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
10.0%
1/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.42%
1/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
1.3%
3/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.1%
5/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
2.9%
6/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
5.4%
13/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/242 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/241 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/226 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/43 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/244 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/237 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
10.0%
1/10 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.00%
0/208 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
|
0.42%
1/239 • During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Analysis Population Description: Safety Population
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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