Trial Outcomes & Findings for A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) in Participants With Metastatic Breast Cancer (NCT NCT01674062)
NCT ID: NCT01674062
Last Updated: 2016-08-22
Results Overview
Tumor response was assessed using RECIST version 1.0 to determine the objective response (OR) rate, or the percentage of participants with either confirmed CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter compared to Baseline. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The OR rate was calculated as \[number of participants meeting the above criteria divided by the number analyzed\] multiplied by 100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
95 participants
Primary outcome timeframe
Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)
Results posted on
2016-08-22
Participant Flow
A total of 99 participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer were screened for Cohorts 1 and 2, of whom 66 were recruited. Following primary analysis of Cohorts 1 and 2, a total of 51 new participants were screened for Cohort 3, of whom 29 were recruited.
Participant milestones
| Measure |
Pertuzumab + Trastuzumab (Cohorts 1 and 2)
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via intravenous (IV) infusion as 2 milligrams per kilogram (mg/kg) once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 milligrams (mg) followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
|
Pertuzumab +/- Trastuzumab (Cohort 3)
Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
29
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
66
|
29
|
Reasons for withdrawal
| Measure |
Pertuzumab + Trastuzumab (Cohorts 1 and 2)
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via intravenous (IV) infusion as 2 milligrams per kilogram (mg/kg) once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 milligrams (mg) followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
|
Pertuzumab +/- Trastuzumab (Cohort 3)
Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
|
|---|---|---|
|
Overall Study
Insufficient Therapeutic Response
|
56
|
26
|
|
Overall Study
Other
|
8
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Programming Error
|
1
|
0
|
Baseline Characteristics
A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) in Participants With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Pertuzumab + Trastuzumab (Cohorts 1 and 2)
n=66 Participants
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
|
Pertuzumab +/- Trastuzumab (Cohort 3)
n=29 Participants
Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 12.60 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 7.95 • n=7 Participants
|
54.3 years
STANDARD_DEVIATION 11.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
95 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: Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)Population: All Treated Population (Cohorts 1 and 2 only).
Tumor response was assessed using RECIST version 1.0 to determine the objective response (OR) rate, or the percentage of participants with either confirmed CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter compared to Baseline. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The OR rate was calculated as \[number of participants meeting the above criteria divided by the number analyzed\] multiplied by 100.
Outcome measures
| Measure |
Pertuzumab + Trastuzumab (Cohorts 1 and 2)
n=66 Participants
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
|
|---|---|
|
Cohorts 1 and 2: Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 During Dual-Agent Treatment
|
24.2 percentage of participants
Interval 17.4 to 32.3
|
PRIMARY outcome
Timeframe: Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)Population: All Treated Population (Cohorts 1 and 2 only).
Tumor response was assessed using RECIST version 1.0 to determine the clinical benefit response (CBR) rate, or the percentage of participants with either confirmed CR or PR, or SD lasting at least 6 months. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The CBR rate was calculated as \[number of participants meeting the above criteria divided by the number analyzed\] multiplied by 100.
Outcome measures
| Measure |
Pertuzumab + Trastuzumab (Cohorts 1 and 2)
n=66 Participants
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
|
|---|---|
|
Cohorts 1 and 2: Percentage of Participants With a Confirmed Best Overall Response of CR, PR, or Stable Disease (SD) According to RECIST Version 1.0 During Dual-Agent Treatment
|
50.0 percentage of participants
Interval 41.5 to 58.5
|
SECONDARY outcome
Timeframe: Up to approximately 7.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)Population: All Treated Population (Cohort 3 only).
Tumor response was assessed using RECIST version 1.0 to determine the OR rate, or the percentage of participants with either confirmed CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The OR rate was calculated as \[number of participants meeting the above criteria divided by the number analyzed\] multiplied by 100.
Outcome measures
| Measure |
Pertuzumab + Trastuzumab (Cohorts 1 and 2)
n=29 Participants
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
|
|---|---|
|
Cohort 3: Percentage of Participants With a Confirmed Best Overall Response of CR or PR According to RECIST Version 1.0 During Single-Agent Treatment With Pertuzumab
|
3.4 percentage of participants
Interval 0.4 to 12.8
|
SECONDARY outcome
Timeframe: Up to approximately 7.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)Population: All Treated Population (Cohort 3 only).
Tumor response was assessed using RECIST version 1.0 to determine the CBR rate, or the percentage of participants with either confirmed CR or PR, or SD lasting at least 6 months. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The CBR rate was calculated as \[number of participants meeting the above criteria divided by the number analyzed\] multiplied by 100.
Outcome measures
| Measure |
Pertuzumab + Trastuzumab (Cohorts 1 and 2)
n=29 Participants
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
|
|---|---|
|
Cohort 3: Percentage of Participants With a Confirmed Best Overall Response of CR, PR, or SD According to RECIST Version 1.0 During Single-Agent Treatment With Pertuzumab
|
10.3 percentage of participants
Interval 3.9 to 21.6
|
SECONDARY outcome
Timeframe: Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)Population: All Treated Population (Cohorts 1 and 2 only).
Tumor response was assessed using RECIST version 1.0 to determine OR and CBR rates. Duration of OR was defined as time from initial response of CR or PR to time of disease progression or death. Duration of CBR was defined similarly as time from initial response of CR or PR, or SD lasting at least 6 months, to time of disease progression or death. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Participants without progression or death following confirmed CR or PR were censored at the last tumor assessment. Duration of response was estimated using Kaplan-Meier analysis and expressed in weeks.
Outcome measures
| Measure |
Pertuzumab + Trastuzumab (Cohorts 1 and 2)
n=66 Participants
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
|
|---|---|
|
Cohorts 1 and 2: Duration of Response According to RECIST Version 1.0
Clinical benefit response
|
50.14 weeks
Interval 12.4 to 183.7
|
|
Cohorts 1 and 2: Duration of Response According to RECIST Version 1.0
Objective response
|
40.1 weeks
Interval 12.0 to 413.0
|
SECONDARY outcome
Timeframe: Up to approximately 21 months (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression; final analysis using February 2008 cutoff date)Population: All Treated Population (Cohorts 1 and 2 only).
Tumor response was assessed using RECIST version 1.0 to determine the OR rate. Time to response was defined as the time from first dose to the time of initial response of CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. Participants with disease progression were censored at the time of progression, and those with neither disease progression nor OR were censored at the last tumor assessment. Time to response was estimated using Kaplan-Meier analysis and expressed in weeks.
Outcome measures
| Measure |
Pertuzumab + Trastuzumab (Cohorts 1 and 2)
n=66 Participants
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
|
|---|---|
|
Cohorts 1 and 2: Time to Objective Response According to RECIST Version 1.0
|
11.14 weeks
Interval 4.9 to 37.3
|
SECONDARY outcome
Timeframe: Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)Population: All Treated Population (Cohorts 1 and 2 only).
Tumor response was assessed using RECIST version 1.0 to assess for disease progression, defined as at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. The percentage of participants with disease progression was calculated as \[number of participants meeting the above criteria divided by the number analyzed\] multiplied by 100.
Outcome measures
| Measure |
Pertuzumab + Trastuzumab (Cohorts 1 and 2)
n=66 Participants
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
|
|---|---|
|
Cohorts 1 and 2: Percentage of Participants With Disease Progression According to RECIST Version 1.0
|
93.9 percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)Population: All Treated Population (Cohorts 1 and 2 only).
Tumor response was assessed using RECIST version 1.0 to assess for disease progression, defined as at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. TTP was defined as the time from first dose to the time of first documented disease progression. Participants who withdrew from the study without documented progression were censored at the last tumor assessment. TTP was estimated using Kaplan-Meier analysis and expressed in weeks.
Outcome measures
| Measure |
Pertuzumab + Trastuzumab (Cohorts 1 and 2)
n=66 Participants
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
|
|---|---|
|
Cohorts 1 and 2: Time to Progression (TTP) According to RECIST Version 1.0
|
23.2 weeks
Interval 4.0 to 244.0
|
SECONDARY outcome
Timeframe: Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)Population: All Treated Population (Cohorts 1 and 2 only).
Tumor response was assessed using RECIST version 1.0 to assess for disease progression, defined as at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. PFS was defined as the time from first dose to the time of disease progression or death. Participants without progression or death were censored at the last tumor assessment. PFS was estimated using Kaplan-Meier analysis and expressed in weeks.
Outcome measures
| Measure |
Pertuzumab + Trastuzumab (Cohorts 1 and 2)
n=66 Participants
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
|
|---|---|
|
Cohorts 1 and 2: Progression-Free Survival (PFS) According to RECIST Version 1.0
|
24.0 weeks
Interval 18.0 to 34.0
|
SECONDARY outcome
Timeframe: Up to approximately 4.5 years (during treatment; then every 4 months until death, withdrawn consent, loss to follow-up, or 3 years after last dose; final analysis using November 2010 cutoff date)Population: All Treated Population (Cohorts 1 and 2 only).
Participants were followed for survival data during and after treatment for a maximum of 3 years after the last dose until death, withdrawal of consent, or loss to follow-up. The percentage of participants who died was calculated as \[number of participants with event divided by the number analyzed\] multiplied by 100.
Outcome measures
| Measure |
Pertuzumab + Trastuzumab (Cohorts 1 and 2)
n=66 Participants
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
|
|---|---|
|
Cohorts 1 and 2: Percentage of Participants Who Died
|
30.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 4.5 years (during treatment; then every 4 months until death, withdrawn consent, loss to follow-up, or 3 years after last dose; final analysis using November 2010 cutoff date)Population: All Treated Population (Cohorts 1 and 2 only).
Participants were followed for survival data during and after treatment for a maximum of 3 years after the last dose until death, withdrawal of consent, or loss to follow-up. OS was defined as the time from first dose to the time of death from any cause. Participants who did not experience death were censored at the last known alive date. OS was estimated using Kaplan-Meier and expressed in months.
Outcome measures
| Measure |
Pertuzumab + Trastuzumab (Cohorts 1 and 2)
n=66 Participants
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
|
|---|---|
|
Cohorts 1 and 2: Overall Survival (OS)
|
38.5 months
Interval 32.0 to
The value could not be calculated due to insufficient follow-up at the time the analysis was conducted.
|
Adverse Events
Pertuzumab + Trastuzumab (Cohorts 1 and 2)
Serious events: 12 serious events
Other events: 62 other events
Deaths: 0 deaths
Pertuzumab +/- Trastuzumab (Cohort 3)
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pertuzumab + Trastuzumab (Cohorts 1 and 2)
n=66 participants at risk
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
|
Pertuzumab +/- Trastuzumab (Cohort 3)
n=29 participants at risk
Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
3.4%
1/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Nervous system disorders
Osmotic demyelination syndrome
|
0.00%
0/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
3.4%
1/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Infections and infestations
Cellulitis
|
1.5%
1/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Infections and infestations
Device related infection
|
1.5%
1/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Infections and infestations
Pneumonia
|
1.5%
1/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
2/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Cardiac disorders
Palpitations
|
1.5%
1/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Gastrointestinal disorders
Haematemesis
|
1.5%
1/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
General disorders
Performance status decreased
|
1.5%
1/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.5%
1/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.5%
1/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Nervous system disorders
Loss of consciousness
|
1.5%
1/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Surgical and medical procedures
Toe amputation
|
1.5%
1/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Vascular disorders
Deep vein thrombosis
|
1.5%
1/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Nervous system disorders
Dizziness
|
1.5%
1/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Psychiatric disorders
Paranoia
|
1.5%
1/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Infections and infestations
Pneumonia pneumococcal
|
1.5%
1/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
Other adverse events
| Measure |
Pertuzumab + Trastuzumab (Cohorts 1 and 2)
n=66 participants at risk
Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
|
Pertuzumab +/- Trastuzumab (Cohort 3)
n=29 participants at risk
Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
63.6%
42/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
55.2%
16/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Gastrointestinal disorders
Nausea
|
28.8%
19/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
41.4%
12/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Gastrointestinal disorders
Vomiting
|
13.6%
9/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
34.5%
10/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Gastrointestinal disorders
Constipation
|
13.6%
9/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
10.3%
3/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.1%
8/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
6.9%
2/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.6%
5/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
13.8%
4/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.5%
3/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
10.3%
3/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
4/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
6.9%
2/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Gastrointestinal disorders
Stomatitis
|
9.1%
6/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Gastrointestinal disorders
Haemorroids
|
6.1%
4/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
6.9%
2/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
General disorders
Fatigue
|
36.4%
24/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
27.6%
8/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
General disorders
Asthenia
|
13.6%
9/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
20.7%
6/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
General disorders
Pyrexia
|
9.1%
6/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
6.9%
2/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
General disorders
Chest pain
|
7.6%
5/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
6.9%
2/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
General disorders
Chills
|
6.1%
4/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
10.3%
3/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
General disorders
Mucosal inflammation
|
9.1%
6/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
3.4%
1/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
General disorders
Influenza like illness
|
4.5%
3/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
10.3%
3/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
General disorders
Oedema peripheral
|
7.6%
5/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.2%
12/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
13.8%
4/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.2%
12/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
4/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
24.1%
7/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
15.2%
10/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
3.4%
1/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
6/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
10.3%
3/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.6%
5/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
10.3%
3/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.3%
18/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
17.2%
5/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.6%
9/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
13.8%
4/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
12.1%
8/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
6.9%
2/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.6%
5/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
3.4%
1/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
7.6%
5/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
6.1%
4/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.5%
1/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
6.9%
2/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Nervous system disorders
Headache
|
22.7%
15/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
13.8%
4/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Nervous system disorders
Dizziness
|
13.6%
9/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
10.3%
3/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Nervous system disorders
Paraesthesia
|
12.1%
8/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Nervous system disorders
Hypoaesthesia
|
6.1%
4/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
12/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
13.8%
4/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
6/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
10.3%
3/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.5%
3/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
10.3%
3/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.1%
4/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Infections and infestations
Nasopharyngitis
|
12.1%
8/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
3.4%
1/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.5%
3/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
10.3%
3/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Infections and infestations
Localised infection
|
7.6%
5/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
0.00%
0/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Infections and infestations
Rhinitis
|
6.1%
4/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
3.4%
1/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Infections and infestations
Urinary tract infection
|
6.1%
4/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
3.4%
1/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
11/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
20.7%
6/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Psychiatric disorders
Insomnia
|
6.1%
4/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
3.4%
1/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Investigations
Weight decreased
|
0.00%
0/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
13.8%
4/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
|
Cardiac disorders
Left ventricular dysfunction
|
1.5%
1/66 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
6.9%
2/29 • Up to approximately 9.5 years (from Day 1 until treatment discontinuation)
Analysis Population Description: All Treated Population.
|
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