Trial Outcomes & Findings for ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib (NCT NCT00272987)
NCT ID: NCT00272987
Last Updated: 2023-04-28
Results Overview
Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to lapatinib, trastuzumab and paclitaxel is calculated as the number of weeks between the start and end of treatment.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
63 participants
Primary outcome timeframe
From the date of the first dose of the investigational product to end of study, up to approx. 14 years
Results posted on
2023-04-28
Participant Flow
Female participants (par.) with histologically confirmed invasive breast cancer (Stage IV disease) whose tumors overexpressed the ErbB2 protein, documented by either Immunohistochemistry (IHC) or fluorescence in situ hybridisation (FISH), were eligible for inclusion in this study.
Participants who met inclusion criteria were sequentially enrolled into three cohorts and received the open-label triple combination of paclitaxel, trastuzumab and lapatinib. The planned randomized phase of the study was terminated following the poor recruitment rate in the Open-label Phase.
Participant milestones
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
14
|
20
|
|
Overall Study
COMPLETED
|
20
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
11
|
Reasons for withdrawal
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
|
Overall Study
Sponsor Terminated study
|
0
|
1
|
1
|
|
Overall Study
Disease progression
|
1
|
1
|
2
|
|
Overall Study
Non-compliant- study visits, trtmnts, req. surgery
|
2
|
1
|
4
|
|
Overall Study
Death
|
1
|
0
|
0
|
Baseline Characteristics
ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib
Baseline characteristics by cohort
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=29 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.5 Years
STANDARD_DEVIATION 11.08 • n=93 Participants
|
56.1 Years
STANDARD_DEVIATION 11.92 • n=4 Participants
|
52.2 Years
STANDARD_DEVIATION 13.00 • n=27 Participants
|
52.7 Years
STANDARD_DEVIATION 11.84 • n=483 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
63 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
7 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
22 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
49 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: From the date of the first dose of the investigational product to end of study, up to approx. 14 yearsPopulation: Safety Population: all participants who were randomized and received at least one dose of investigational product.
Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to lapatinib, trastuzumab and paclitaxel is calculated as the number of weeks between the start and end of treatment.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=29 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Extent of Exposure to Lapatinib, Trastuzumab and Paclitaxel by Mean/Standard Deviation
Lapatinib
|
70.9 Weeks
Standard Deviation 115.44
|
93.1 Weeks
Standard Deviation 147.92
|
82.5 Weeks
Standard Deviation 135.79
|
|
Extent of Exposure to Lapatinib, Trastuzumab and Paclitaxel by Mean/Standard Deviation
Trastuzumab
|
60.7 Weeks
Standard Deviation 72.07
|
72.2 Weeks
Standard Deviation 88.66
|
62.3 Weeks
Standard Deviation 75.52
|
|
Extent of Exposure to Lapatinib, Trastuzumab and Paclitaxel by Mean/Standard Deviation
Paclitaxel
|
26.9 Weeks
Standard Deviation 16.88
|
29.4 Weeks
Standard Deviation 23.00
|
23.8 Weeks
Standard Deviation 14.87
|
PRIMARY outcome
Timeframe: From the date of the first dose of the investigational product to end of study, up to approx. 14 yearsPopulation: Safety Population: all participants who were randomized and received at least one dose of investigational product.
Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to lapatinib, trastuzumab and paclitaxel is calculated as the number of weeks between the start and end of treatment.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=29 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Extent of Exposure to Lapatinib, Trastuzumab and Paclitaxel by Median/Min-Max
Lapatinib
|
33.0 Weeks
Interval 3.0 to 615.0
|
38.5 Weeks
Interval 2.0 to 547.0
|
32.5 Weeks
Interval 1.0 to 574.0
|
|
Extent of Exposure to Lapatinib, Trastuzumab and Paclitaxel by Median/Min-Max
Trastuzumab
|
33.0 Weeks
Interval 2.0 to 343.0
|
37.0 Weeks
Interval 2.0 to 271.0
|
31.5 Weeks
Interval 1.0 to 245.0
|
|
Extent of Exposure to Lapatinib, Trastuzumab and Paclitaxel by Median/Min-Max
Paclitaxel
|
22.0 Weeks
Interval 2.0 to 86.0
|
23.5 Weeks
Interval 2.0 to 94.0
|
22.0 Weeks
Interval 1.0 to 63.0
|
PRIMARY outcome
Timeframe: From the date of the first dose of investigational product until 30 days after the last dose of investigational product, up to approx. 14 yearsPopulation: Safety Population: all participants who were randomized and received at least one dose of investigational product.
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=29 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Any AEs
|
29 Participants
|
14 Participants
|
20 Participants
|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Any SAEs
|
14 Participants
|
6 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From the date of the first dose of investigational product until last patient last visit, up to approximately 14 yearsPopulation: Safety Population: all participants who were randomized and received at least one dose of investigational product.
Number of participants who died due to any cause throughout the study including off-treatment deaths (on-treatment deaths are reported for the All-Cause Mortality in the AE section).
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=29 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Number of Participants Who Died Due to Any Cause
|
12 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From the date of the first dose of investigational product until 30 days after the last dose of investigational product, up to approx. 3.5 yearsPopulation: Safety Population. Only the participants with at least one event of diarrhea were analyzed.
Events of diarrhea are characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. Participants could have been counted in more than one category.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=28 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=13 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=13 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Number of Events of Diarrhea With the Indicated Characteristics
Any Event
|
358 Events of diarrhea
|
90 Events of diarrhea
|
37 Events of diarrhea
|
|
Number of Events of Diarrhea With the Indicated Characteristics
Serious
|
4 Events of diarrhea
|
0 Events of diarrhea
|
0 Events of diarrhea
|
|
Number of Events of Diarrhea With the Indicated Characteristics
Related to investigational product
|
347 Events of diarrhea
|
75 Events of diarrhea
|
26 Events of diarrhea
|
|
Number of Events of Diarrhea With the Indicated Characteristics
Leading to withdrawal from study
|
2 Events of diarrhea
|
1 Events of diarrhea
|
1 Events of diarrhea
|
|
Number of Events of Diarrhea With the Indicated Characteristics
Fatal
|
0 Events of diarrhea
|
0 Events of diarrhea
|
0 Events of diarrhea
|
PRIMARY outcome
Timeframe: From the date of the first dose of investigational product until 30 days after the last dose of investigational product, up to approx. 3.5 yearsPopulation: Safety Population. Only the participants with at least one event of rash were analyzed.
Events of rash are characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. Participants could have been counted in more than one category.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=24 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=8 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=15 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Number of Events of Rash With the Indicated Characteristics
Any Event
|
69 Events of rash
|
23 Events of rash
|
20 Events of rash
|
|
Number of Events of Rash With the Indicated Characteristics
Serious
|
2 Events of rash
|
0 Events of rash
|
0 Events of rash
|
|
Number of Events of Rash With the Indicated Characteristics
Related to investigational product
|
55 Events of rash
|
12 Events of rash
|
7 Events of rash
|
|
Number of Events of Rash With the Indicated Characteristics
Leading to withdrawal from study
|
3 Events of rash
|
0 Events of rash
|
0 Events of rash
|
|
Number of Events of Rash With the Indicated Characteristics
Fatal
|
0 Events of rash
|
0 Events of rash
|
0 Events of rash
|
PRIMARY outcome
Timeframe: Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 yearsPopulation: Safety Population: all participants who were randomized and received at least one dose of investigational product.
Blood samples for clinical laboratory evaluation were taken at Baseline prior to the administration of investigational product and thereafter at each scheduled visit. Haematology parameters included haemoglobin, total white blood cell count (WBC), neutrophils, lymphocytes and platelets. Hematology data was summarized by the National Cancer Institute's Common toxicity criteria for adverse events (NCI CTCAE) toxicity grade (Version 3.0). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=29 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Haemaglobin, Grade 1
|
19 Participants
|
11 Participants
|
11 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Haemaglobin, Grade 2
|
7 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Haemaglobin, Grade 3
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Haemaglobin, Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Platelets, Grade 1
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Platelets, Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Platelets, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Platelets, Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Total WBC, Grade 1
|
10 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Total WBC, Grade 2
|
8 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Total WBC, Grade 3
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Total WBC, Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Neutrophils, Grade 1
|
7 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Neutrophils, Grade 2
|
7 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Neutrophils, Grade 3
|
3 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Neutrophils, Grade 4
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Lymphocytes, Grade 1
|
5 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Lymphocytes, Grade 2
|
10 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Lymphocytes, Grade 3
|
5 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters
Lymphocytes, Grade 4
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 yearsPopulation: Safety Population. Only those participants available at the specified time points were analyzed.
Blood samples for clinical laboratory evaluation were taken at Baseline prior to the administration of investigational product and thereafter at each scheduled visit. Clinical chemistry parameters included values \> upper limit of normal (ULN)=Hyper; values \< lower limit of normal (LLN)=Hypo of sodium (Hypernatraemia and Hyponatraemia), potassium (Hyperkalaemia and Hypokalaemia), calcium (Hypercalcaemia and Hypocalcaemia), glucose (Hyperglycaemia and Hyperglycaemia), creatinine (if \>2 milligram per deciliter \[mg/dL\]), aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phophatase, total bilirubin (if available bilirubin fractionation is recommended if the total bilirubin is \> twice of ULN), and albumin. Clinical chemistry data was summarized by National Cancer Institute's Common toxicity criteria for adverse events (NCI CTCAE) toxicity grade (Version 3.0). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=29 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypocalcaemia, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hyperkalaemia, Grade 1
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hyperkalaemia, Grade 2
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hyperkalaemia, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hyperkalaemia, Grade 4
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypokalaemia, Grade 1
|
11 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypokalaemia, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypokalaemia, Grade 3
|
6 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypokalaemia, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypercalcaemia, Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypercalcaemia, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypercalcaemia, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypercalcaemia, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypocalcaemia, Grade 1
|
10 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypocalcaemia, Grade 2
|
7 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypocalcaemia, Grade 3
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hyperglycaemia, Grade 1
|
15 Participants
|
9 Participants
|
6 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hyperglycaemia, Grade 2
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hyperglycaemia, Grade 3
|
5 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hyperglycaemia, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypoglycemia, Grade 1
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypoglycemia, Grade 2
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypoglycemia, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypoglycemia, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Albumin, Grade 1
|
5 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Albumin, Grade 2
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Albumin, Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Albumin, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Total Bilirubin, Grade 1
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Total Bilirubin, Grade 2
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Total Bilirubin, Grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Total Bilirubin, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Creatinine, Grade 1
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Creatinine, Grade 2
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Creatinine, Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Creatinine, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Alkaline Phophatase, Grade 1
|
14 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Alkaline Phophatase, Grade 2
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Alkaline Phophatase, Grade 3
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Alkaline Phophatase, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
ALT, Grade 1
|
7 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
ALT, Grade 2
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
ALT, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
ALT, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
AST, Grade 1
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
AST, Grade 2
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
AST, Grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
AST, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypernatraemia, Grade 1
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypernatraemia, Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypernatraemia, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hypernatraemia, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hyponatraemia, Grade 1
|
8 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hyponatraemia, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hyponatraemia, Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters
Hyponatraemia, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the date of the first dose of investigational product until 30 days after the last dose of investigational product, up to approx. 3.5 yearsPopulation: Safety Population. Only the participants with at least one of event of hepatotoxicity were analyzed.
Events of hepatotoxicity are characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. Participants could have been counted in more than one category.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=6 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=2 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Number of Events of Hepatotoxicity With the Indicated Characteristics
Any Event
|
6 Events of hepatotoxicity
|
—
|
2 Events of hepatotoxicity
|
|
Number of Events of Hepatotoxicity With the Indicated Characteristics
Serious
|
0 Events of hepatotoxicity
|
—
|
0 Events of hepatotoxicity
|
|
Number of Events of Hepatotoxicity With the Indicated Characteristics
Related to investigational product
|
5 Events of hepatotoxicity
|
—
|
0 Events of hepatotoxicity
|
|
Number of Events of Hepatotoxicity With the Indicated Characteristics
Leading to withdrawal from study
|
0 Events of hepatotoxicity
|
—
|
0 Events of hepatotoxicity
|
|
Number of Events of Hepatotoxicity With the Indicated Characteristics
Fatal
|
0 Events of hepatotoxicity
|
—
|
0 Events of hepatotoxicity
|
PRIMARY outcome
Timeframe: Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 yearsPopulation: Safety Population: all participants who were randomized and received at least one dose of investigational product. Only those participants available at the specified time points were analyzed.
Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=29 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 120
|
13.3 Millimeter of mercury (mmHg)
Standard Deviation 19.86
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 124
|
7.3 Millimeter of mercury (mmHg)
Standard Deviation 8.50
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 128
|
-11.0 Millimeter of mercury (mmHg)
Standard Deviation 9.90
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 132
|
-10.5 Millimeter of mercury (mmHg)
Standard Deviation 10.61
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 136
|
-4.0 Millimeter of mercury (mmHg)
Standard Deviation 18.38
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 140
|
4.5 Millimeter of mercury (mmHg)
Standard Deviation 23.33
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 148
|
25.0 Millimeter of mercury (mmHg)
Standard Deviation NA
NA: Data not available as the sample size is 1.
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Withdrawal/Study Conclusion
|
0.5 Millimeter of mercury (mmHg)
Standard Deviation 16.13
|
-1.3 Millimeter of mercury (mmHg)
Standard Deviation 15.64
|
7.0 Millimeter of mercury (mmHg)
Standard Deviation 20.28
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, 30 Day Follow-up
|
2.4 Millimeter of mercury (mmHg)
Standard Deviation 19.18
|
-3.9 Millimeter of mercury (mmHg)
Standard Deviation 17.03
|
13.8 Millimeter of mercury (mmHg)
Standard Deviation 19.25
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 4
|
-2.5 Millimeter of mercury (mmHg)
Standard Deviation 10.36
|
-3.9 Millimeter of mercury (mmHg)
Standard Deviation 10.50
|
-4.8 Millimeter of mercury (mmHg)
Standard Deviation 11.10
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 8
|
-0.6 Millimeter of mercury (mmHg)
Standard Deviation 11.41
|
-8.9 Millimeter of mercury (mmHg)
Standard Deviation 11.54
|
-1.2 Millimeter of mercury (mmHg)
Standard Deviation 12.46
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 12
|
-0.3 Millimeter of mercury (mmHg)
Standard Deviation 10.19
|
-6.2 Millimeter of mercury (mmHg)
Standard Deviation 10.37
|
-4.2 Millimeter of mercury (mmHg)
Standard Deviation 12.87
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 16
|
-3.4 Millimeter of mercury (mmHg)
Standard Deviation 12.98
|
-3.2 Millimeter of mercury (mmHg)
Standard Deviation 8.42
|
-4.4 Millimeter of mercury (mmHg)
Standard Deviation 15.18
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 20
|
-3.0 Millimeter of mercury (mmHg)
Standard Deviation 12.65
|
-1.6 Millimeter of mercury (mmHg)
Standard Deviation 9.53
|
-9.1 Millimeter of mercury (mmHg)
Standard Deviation 13.65
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 24
|
-1.2 Millimeter of mercury (mmHg)
Standard Deviation 11.30
|
-1.8 Millimeter of mercury (mmHg)
Standard Deviation 6.56
|
-5.2 Millimeter of mercury (mmHg)
Standard Deviation 13.08
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 28
|
-1.8 Millimeter of mercury (mmHg)
Standard Deviation 14.27
|
-2.1 Millimeter of mercury (mmHg)
Standard Deviation 8.15
|
-2.0 Millimeter of mercury (mmHg)
Standard Deviation 5.05
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 32
|
-2.2 Millimeter of mercury (mmHg)
Standard Deviation 13.70
|
-6.3 Millimeter of mercury (mmHg)
Standard Deviation 10.24
|
-4.7 Millimeter of mercury (mmHg)
Standard Deviation 6.51
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 36
|
-7.2 Millimeter of mercury (mmHg)
Standard Deviation 6.48
|
-3.3 Millimeter of mercury (mmHg)
Standard Deviation 6.40
|
-10.7 Millimeter of mercury (mmHg)
Standard Deviation 11.02
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 40
|
-9.3 Millimeter of mercury (mmHg)
Standard Deviation 11.36
|
-0.7 Millimeter of mercury (mmHg)
Standard Deviation 13.76
|
-8.0 Millimeter of mercury (mmHg)
Standard Deviation 19.80
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 44
|
-9.0 Millimeter of mercury (mmHg)
Standard Deviation 6.59
|
-2.3 Millimeter of mercury (mmHg)
Standard Deviation 10.33
|
-19.5 Millimeter of mercury (mmHg)
Standard Deviation 6.36
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 48
|
-3.9 Millimeter of mercury (mmHg)
Standard Deviation 7.57
|
-0.2 Millimeter of mercury (mmHg)
Standard Deviation 8.13
|
-34.0 Millimeter of mercury (mmHg)
Standard Deviation NA
NA: Data not available as the sample size is 1
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 76
|
-4.8 Millimeter of mercury (mmHg)
Standard Deviation 5.00
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 80
|
-3.5 Millimeter of mercury (mmHg)
Standard Deviation 5.58
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 84
|
-5.8 Millimeter of mercury (mmHg)
Standard Deviation 9.50
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 52
|
-7.4 Millimeter of mercury (mmHg)
Standard Deviation 13.46
|
-3.0 Millimeter of mercury (mmHg)
Standard Deviation 12.33
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 56
|
-5.1 Millimeter of mercury (mmHg)
Standard Deviation 8.62
|
-3.4 Millimeter of mercury (mmHg)
Standard Deviation 7.99
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 88
|
-9.3 Millimeter of mercury (mmHg)
Standard Deviation 11.48
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 92
|
-3.8 Millimeter of mercury (mmHg)
Standard Deviation 5.26
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 60
|
-3.6 Millimeter of mercury (mmHg)
Standard Deviation 11.56
|
-6.3 Millimeter of mercury (mmHg)
Standard Deviation 6.24
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 64
|
-7.7 Millimeter of mercury (mmHg)
Standard Deviation 12.27
|
-5.3 Millimeter of mercury (mmHg)
Standard Deviation 8.54
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 68
|
-11.0 Millimeter of mercury (mmHg)
Standard Deviation 6.40
|
-3.5 Millimeter of mercury (mmHg)
Standard Deviation 7.78
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 72
|
3.0 Millimeter of mercury (mmHg)
Standard Deviation 9.26
|
-16.0 Millimeter of mercury (mmHg)
Standard Deviation NA
NA: Data not available as the sample size is 1.
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 4
|
0.5 Millimeter of mercury (mmHg)
Standard Deviation 16.29
|
-7.2 Millimeter of mercury (mmHg)
Standard Deviation 20.70
|
-3.9 Millimeter of mercury (mmHg)
Standard Deviation 22.76
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 8
|
4.6 Millimeter of mercury (mmHg)
Standard Deviation 12.35
|
-8.6 Millimeter of mercury (mmHg)
Standard Deviation 22.25
|
-2.7 Millimeter of mercury (mmHg)
Standard Deviation 24.73
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 12
|
3.2 Millimeter of mercury (mmHg)
Standard Deviation 18.46
|
-6.9 Millimeter of mercury (mmHg)
Standard Deviation 17.09
|
-9.3 Millimeter of mercury (mmHg)
Standard Deviation 23.54
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 16
|
0.8 Millimeter of mercury (mmHg)
Standard Deviation 18.10
|
-6.6 Millimeter of mercury (mmHg)
Standard Deviation 15.26
|
-7.9 Millimeter of mercury (mmHg)
Standard Deviation 24.43
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 20
|
1.7 Millimeter of mercury (mmHg)
Standard Deviation 17.80
|
-11.5 Millimeter of mercury (mmHg)
Standard Deviation 14.69
|
-13.8 Millimeter of mercury (mmHg)
Standard Deviation 25.15
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 24
|
2.9 Millimeter of mercury (mmHg)
Standard Deviation 13.87
|
-1.8 Millimeter of mercury (mmHg)
Standard Deviation 11.81
|
-7.8 Millimeter of mercury (mmHg)
Standard Deviation 26.06
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 28
|
2.3 Millimeter of mercury (mmHg)
Standard Deviation 19.10
|
-5.7 Millimeter of mercury (mmHg)
Standard Deviation 20.38
|
-5.2 Millimeter of mercury (mmHg)
Standard Deviation 10.71
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 32
|
3.2 Millimeter of mercury (mmHg)
Standard Deviation 23.11
|
-16.4 Millimeter of mercury (mmHg)
Standard Deviation 10.03
|
-6.3 Millimeter of mercury (mmHg)
Standard Deviation 5.51
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 36
|
1.6 Millimeter of mercury (mmHg)
Standard Deviation 15.85
|
-8.7 Millimeter of mercury (mmHg)
Standard Deviation 12.19
|
-26.7 Millimeter of mercury (mmHg)
Standard Deviation 37.75
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 40
|
-2.2 Millimeter of mercury (mmHg)
Standard Deviation 24.44
|
-3.4 Millimeter of mercury (mmHg)
Standard Deviation 9.62
|
-34.0 Millimeter of mercury (mmHg)
Standard Deviation 38.18
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 44
|
2.7 Millimeter of mercury (mmHg)
Standard Deviation 14.47
|
-3.8 Millimeter of mercury (mmHg)
Standard Deviation 9.83
|
-38.0 Millimeter of mercury (mmHg)
Standard Deviation 32.53
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 48
|
6.5 Millimeter of mercury (mmHg)
Standard Deviation 18.76
|
-6.7 Millimeter of mercury (mmHg)
Standard Deviation 11.18
|
-84.0 Millimeter of mercury (mmHg)
Standard Deviation NA
NA: Data not available as the sample size is 1.
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 52
|
7.7 Millimeter of mercury (mmHg)
Standard Deviation 14.47
|
-3.8 Millimeter of mercury (mmHg)
Standard Deviation 24.78
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 56
|
8.4 Millimeter of mercury (mmHg)
Standard Deviation 13.53
|
-8.2 Millimeter of mercury (mmHg)
Standard Deviation 18.74
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 60
|
9.3 Millimeter of mercury (mmHg)
Standard Deviation 22.07
|
-17.0 Millimeter of mercury (mmHg)
Standard Deviation 9.31
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 64
|
3.5 Millimeter of mercury (mmHg)
Standard Deviation 16.53
|
-11.3 Millimeter of mercury (mmHg)
Standard Deviation 11.24
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 68
|
0.1 Millimeter of mercury (mmHg)
Standard Deviation 10.71
|
-6.5 Millimeter of mercury (mmHg)
Standard Deviation 12.02
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 72
|
7.1 Millimeter of mercury (mmHg)
Standard Deviation 13.25
|
-20.0 Millimeter of mercury (mmHg)
Standard Deviation NA
NA: Data not available as the sample size is 1.
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 76
|
4.5 Millimeter of mercury (mmHg)
Standard Deviation 12.96
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 80
|
8.7 Millimeter of mercury (mmHg)
Standard Deviation 6.92
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 84
|
7.0 Millimeter of mercury (mmHg)
Standard Deviation 20.20
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 88
|
-2.7 Millimeter of mercury (mmHg)
Standard Deviation 16.32
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 92
|
10.4 Millimeter of mercury (mmHg)
Standard Deviation 16.59
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 96
|
-0.5 Millimeter of mercury (mmHg)
Standard Deviation 4.12
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 100
|
10.8 Millimeter of mercury (mmHg)
Standard Deviation 7.53
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 104
|
7.0 Millimeter of mercury (mmHg)
Standard Deviation 16.00
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 108
|
4.6 Millimeter of mercury (mmHg)
Standard Deviation 7.89
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 112
|
12.3 Millimeter of mercury (mmHg)
Standard Deviation 10.72
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 116
|
9.3 Millimeter of mercury (mmHg)
Standard Deviation 15.22
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 96
|
-7.3 Millimeter of mercury (mmHg)
Standard Deviation 6.29
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 100
|
-4.4 Millimeter of mercury (mmHg)
Standard Deviation 6.50
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 104
|
-4.6 Millimeter of mercury (mmHg)
Standard Deviation 9.10
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 108
|
-2.0 Millimeter of mercury (mmHg)
Standard Deviation 5.89
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 116
|
-8.5 Millimeter of mercury (mmHg)
Standard Deviation 9.33
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 120
|
-6.0 Millimeter of mercury (mmHg)
Standard Deviation 7.94
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 124
|
-6.0 Millimeter of mercury (mmHg)
Standard Deviation 6.00
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 128
|
-12.5 Millimeter of mercury (mmHg)
Standard Deviation 0.71
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 132
|
-14.5 Millimeter of mercury (mmHg)
Standard Deviation 4.95
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 136
|
-17.0 Millimeter of mercury (mmHg)
Standard Deviation 4.24
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 140
|
-7.5 Millimeter of mercury (mmHg)
Standard Deviation 10.61
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 144
|
0.0 Millimeter of mercury (mmHg)
Standard Deviation 0
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Week 148
|
1.0 Millimeter of mercury (mmHg)
Standard Deviation NA
NA: Data not available as the sample size is 1.
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, Withdrawal/Study Conclusion
|
-0.5 Millimeter of mercury (mmHg)
Standard Deviation 11.39
|
-0.4 Millimeter of mercury (mmHg)
Standard Deviation 12.08
|
2.1 Millimeter of mercury (mmHg)
Standard Deviation 8.64
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
DBP, 30 Day Follow-up
|
-0.8 Millimeter of mercury (mmHg)
Standard Deviation 11.96
|
0.8 Millimeter of mercury (mmHg)
Standard Deviation 11.62
|
3.2 Millimeter of mercury (mmHg)
Standard Deviation 9.98
|
|
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
SBP, Week 144
|
10.0 Millimeter of mercury (mmHg)
Standard Deviation 0
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 yearsPopulation: Safety Population. Safety Population: all participants who were randomized and received at least one dose of investigational product. Only those participants available at the specified time points were analyzed.
Heart rate was measured at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=29 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 4
|
-1.714 Beats per minute (BPM)
Standard Deviation 10.9099
|
-3.417 Beats per minute (BPM)
Standard Deviation 26.3593
|
3.333 Beats per minute (BPM)
Standard Deviation 12.1268
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 8
|
-5.667 Beats per minute (BPM)
Standard Deviation 14.7908
|
-3.231 Beats per minute (BPM)
Standard Deviation 16.8481
|
5.353 Beats per minute (BPM)
Standard Deviation 10.7642
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 12
|
-0.217 Beats per minute (BPM)
Standard Deviation 10.7109
|
-0.417 Beats per minute (BPM)
Standard Deviation 15.6812
|
-2.875 Beats per minute (BPM)
Standard Deviation 10.6074
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 16
|
-0.478 Beats per minute (BPM)
Standard Deviation 13.4667
|
2.625 Beats per minute (BPM)
Standard Deviation 15.1369
|
-1.917 Beats per minute (BPM)
Standard Deviation 10.9084
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 24
|
-0.476 Beats per minute (BPM)
Standard Deviation 16.7768
|
-5.300 Beats per minute (BPM)
Standard Deviation 15.1808
|
5.167 Beats per minute (BPM)
Standard Deviation 10.2843
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 28
|
-4.313 Beats per minute (BPM)
Standard Deviation 16.0155
|
-1.429 Beats per minute (BPM)
Standard Deviation 17.7281
|
3.600 Beats per minute (BPM)
Standard Deviation 8.5615
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 32
|
-4.933 Beats per minute (BPM)
Standard Deviation 16.6496
|
-0.500 Beats per minute (BPM)
Standard Deviation 11.1098
|
0.333 Beats per minute (BPM)
Standard Deviation 10.5987
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 36
|
-5.000 Beats per minute (BPM)
Standard Deviation 13.0128
|
4.857 Beats per minute (BPM)
Standard Deviation 18.4791
|
7.000 Beats per minute (BPM)
Standard Deviation 11.5326
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 40
|
-1.000 Beats per minute (BPM)
Standard Deviation 14.1614
|
-3.571 Beats per minute (BPM)
Standard Deviation 17.6149
|
-2.500 Beats per minute (BPM)
Standard Deviation 9.1924
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 44
|
-3.000 Beats per minute (BPM)
Standard Deviation 11.1624
|
-5.000 Beats per minute (BPM)
Standard Deviation 17.9778
|
-0.500 Beats per minute (BPM)
Standard Deviation 10.6066
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 48
|
-5.500 Beats per minute (BPM)
Standard Deviation 8.1955
|
-2.500 Beats per minute (BPM)
Standard Deviation 12.9422
|
-14.000 Beats per minute (BPM)
Standard Deviation NA
NA: Data not available as the sample size is 1
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 52
|
-1.889 Beats per minute (BPM)
Standard Deviation 14.4866
|
-2.000 Beats per minute (BPM)
Standard Deviation 11.8533
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 56
|
-2.000 Beats per minute (BPM)
Standard Deviation 13.4907
|
-2.000 Beats per minute (BPM)
Standard Deviation 15.2151
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 60
|
-2.600 Beats per minute (BPM)
Standard Deviation 13.3766
|
1.500 Beats per minute (BPM)
Standard Deviation 15.0222
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 64
|
-4.667 Beats per minute (BPM)
Standard Deviation 16.1245
|
0.000 Beats per minute (BPM)
Standard Deviation 15.3840
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 68
|
-8.286 Beats per minute (BPM)
Standard Deviation 21.1638
|
1.000 Beats per minute (BPM)
Standard Deviation 25.4558
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 72
|
-0.714 Beats per minute (BPM)
Standard Deviation 21.0295
|
19.000 Beats per minute (BPM)
Standard Deviation NA
NA: Data not available as the sample size is 1.
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 76
|
-0.500 Beats per minute (BPM)
Standard Deviation 16.6463
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 80
|
0.800 Beats per minute (BPM)
Standard Deviation 14.4810
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 84
|
9.200 Beats per minute (BPM)
Standard Deviation 21.1234
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 88
|
2.200 Beats per minute (BPM)
Standard Deviation 24.6110
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 92
|
-2.400 Beats per minute (BPM)
Standard Deviation 10.1390
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 96
|
-8.250 Beats per minute (BPM)
Standard Deviation 7.6322
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 100
|
-6.750 Beats per minute (BPM)
Standard Deviation 13.1751
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 104
|
-6.800 Beats per minute (BPM)
Standard Deviation 15.3525
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 108
|
-8.750 Beats per minute (BPM)
Standard Deviation 6.4485
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 112
|
-0.667 Beats per minute (BPM)
Standard Deviation 15.0444
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 116
|
-4.667 Beats per minute (BPM)
Standard Deviation 14.5717
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 120
|
-7.667 Beats per minute (BPM)
Standard Deviation 9.4516
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 124
|
-5.333 Beats per minute (BPM)
Standard Deviation 13.2035
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 128
|
1.000 Beats per minute (BPM)
Standard Deviation 21.2132
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 132
|
-4.000 Beats per minute (BPM)
Standard Deviation 14.1421
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 136
|
-4.000 Beats per minute (BPM)
Standard Deviation 15.5563
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 140
|
-3.500 Beats per minute (BPM)
Standard Deviation 16.2635
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 144
|
3.000 Beats per minute (BPM)
Standard Deviation NA
NA: Data not available as the sample size is 1.
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Week 148
|
6.000 Beats per minute (BPM)
Standard Deviation NA
NA: Data not available as the sample size is 1.
|
—
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Withdrawal/Study Conclusion
|
-1.435 Beats per minute (BPM)
Standard Deviation 19.3481
|
-7.900 Beats per minute (BPM)
Standard Deviation 19.3990
|
7.750 Beats per minute (BPM)
Standard Deviation 9.8814
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
30 Day Follow-up
|
0.560 Beats per minute (BPM)
Standard Deviation 13.1564
|
-7.889 Beats per minute (BPM)
Standard Deviation 17.3526
|
13.200 Beats per minute (BPM)
Standard Deviation 11.6060
|
PRIMARY outcome
Timeframe: Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 yearsPopulation: Safety Population: all participants who were randomized and received at least one dose of investigational product. Only those participants available at the specified time points were analyzed
Body temperature was measured at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=29 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 4
|
-0.229 Degree Celsius
Standard Deviation 0.5062
|
-0.242 Degree Celsius
Standard Deviation 0.3605
|
0.078 Degree Celsius
Standard Deviation 0.5976
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 8
|
0.011 Degree Celsius
Standard Deviation 0.5250
|
-0.154 Degree Celsius
Standard Deviation 0.4294
|
0.247 Degree Celsius
Standard Deviation 0.4652
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 12
|
0.021 Degree Celsius
Standard Deviation 0.4374
|
-0.567 Degree Celsius
Standard Deviation 0.4960
|
0.173 Degree Celsius
Standard Deviation 0.4636
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 16
|
-0.052 Degree Celsius
Standard Deviation 0.5814
|
-0.127 Degree Celsius
Standard Deviation 0.4880
|
0.121 Degree Celsius
Standard Deviation 0.5494
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 20
|
0.018 Degree Celsius
Standard Deviation 0.5712
|
-0.238 Degree Celsius
Standard Deviation 0.4138
|
0.300 Degree Celsius
Standard Deviation 0.3536
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 24
|
0.157 Degree Celsius
Standard Deviation 0.5006
|
-0.100 Degree Celsius
Standard Deviation 0.4138
|
0.017 Degree Celsius
Standard Deviation 0.5193
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 28
|
-0.094 Degree Celsius
Standard Deviation 0.4956
|
-0.529 Degree Celsius
Standard Deviation 0.4751
|
0.300 Degree Celsius
Standard Deviation 0.3536
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 32
|
-0.156 Degree Celsius
Standard Deviation 0.6077
|
-0.237 Degree Celsius
Standard Deviation 0.2134
|
0.000 Degree Celsius
Standard Deviation 0.2000
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 36
|
-0.215 Degree Celsius
Standard Deviation 0.5728
|
-0.129 Degree Celsius
Standard Deviation 0.3946
|
0.533 Degree Celsius
Standard Deviation 0.3786
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 40
|
0.045 Degree Celsius
Standard Deviation 0.4634
|
-0.314 Degree Celsius
Standard Deviation 0.1952
|
0.450 Degree Celsius
Standard Deviation 0.9192
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 44
|
-0.182 Degree Celsius
Standard Deviation 0.4729
|
-0.217 Degree Celsius
Standard Deviation 0.3920
|
0.250 Degree Celsius
Standard Deviation 0.0707
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 48
|
-0.109 Degree Celsius
Standard Deviation 0.4571
|
-0.200 Degree Celsius
Standard Deviation 0.1414
|
0.300 Degree Celsius
Standard Deviation NA
NA: Data not available as the sample size is 1.
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 52
|
-0.222 Degree Celsius
Standard Deviation 1.0616
|
-0.340 Degree Celsius
Standard Deviation 0.3286
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 56
|
0.111 Degree Celsius
Standard Deviation 0.6489
|
-0.240 Degree Celsius
Standard Deviation 0.6427
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 60
|
-0.070 Degree Celsius
Standard Deviation 0.5889
|
-0.225 Degree Celsius
Standard Deviation 0.2754
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 64
|
-0.080 Degree Celsius
Standard Deviation 0.4662
|
-0.150 Degree Celsius
Standard Deviation 0.1732
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 68
|
0.286 Degree Celsius
Standard Deviation 0.6744
|
-0.550 Degree Celsius
Standard Deviation 0.0707
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 72
|
0.057 Degree Celsius
Standard Deviation 0.7390
|
-0.400 Degree Celsius
Standard Deviation NA
NA: Data not available as the sample size is 1.
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 76
|
0.017 Degree Celsius
Standard Deviation 0.4834
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 80
|
-0.150 Degree Celsius
Standard Deviation 0.6442
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 84
|
0.067 Degree Celsius
Standard Deviation 0.5610
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 88
|
-0.267 Degree Celsius
Standard Deviation 0.4131
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 92
|
-0.200 Degree Celsius
Standard Deviation 0.8155
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 96
|
-0.125 Degree Celsius
Standard Deviation 0.4573
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 100
|
-0.100 Degree Celsius
Standard Deviation 0.9083
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 104
|
-0.160 Degree Celsius
Standard Deviation 0.7436
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 108
|
0.080 Degree Celsius
Standard Deviation 0.6099
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 112
|
0.050 Degree Celsius
Standard Deviation 0.5000
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 116
|
0.250 Degree Celsius
Standard Deviation 0.6403
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 120
|
0.200 Degree Celsius
Standard Deviation 0.4359
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 124
|
0.167 Degree Celsius
Standard Deviation 0.8083
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 128
|
0.200 Degree Celsius
Standard Deviation 1.4142
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 132
|
-0.150 Degree Celsius
Standard Deviation 1.2021
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 136
|
0.000 Degree Celsius
Standard Deviation 1.2728
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 140
|
0.450 Degree Celsius
Standard Deviation 1.3435
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 144
|
1.300 Degree Celsius
Standard Deviation NA
NA: Data not available as the sample size is 1.
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Week 148
|
0.700 Degree Celsius
Standard Deviation NA
NA: Data not available as the sample size is 1.
|
—
|
—
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
Withdrawal/Study Conclusion
|
-0.083 Degree Celsius
Standard Deviation 0.6833
|
-0.020 Degree Celsius
Standard Deviation 0.4367
|
0.237 Degree Celsius
Standard Deviation 0.5999
|
|
Change From Baseline in Body Temperature at the Indicated Time Points
30 Day Follow-up
|
-0.092 Degree Celsius
Standard Deviation 0.6238
|
-0.400 Degree Celsius
Standard Deviation 0.5074
|
0.140 Degree Celsius
Standard Deviation 0.5320
|
PRIMARY outcome
Timeframe: Baseline and every 8 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 yearsPopulation: Safety Population. Only the participants with at least one of event of LVEF decrease were analyzed.
Events of left ventricular ejection fraction (LVEF) decrease were based on the number of participants who had an actual event and was characterized as serious, related to investigational product, leading to withdrawal from the study and/or fatal.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=29 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Number of Participants With at Least 1 Event of Left Ventricular Ejection Fraction Decrease With the Indicated Characteristics
|
8 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 yearsPopulation: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.
The Eastern Cooperative Oncology Group (ECOG) performance status scales and grades/criteria are used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=29 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 96, Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 96, Grade 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 100, Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 100, Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 100, Grade 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 104, Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 104, Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 104, Grade 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 108, Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 108, Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 108, Grade 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 112, Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 112, Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 112, Grade 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 116, Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 116, Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Screening, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Screening, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Screening, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Day 1 pre-dose, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Day 1 pre-dose, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Day 1 pre-dose, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 4, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 4, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 4, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 8, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 8, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 8, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 12, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 12, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 12, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 16, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 16, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 16, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 20, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 20, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 20, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 24, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 24, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 24, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 28, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 28, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 28, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 32, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 32, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 32, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 36, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 36, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 36, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 40, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 40, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 40, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 44, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 44, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 44, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 48, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 48, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 48, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 52, Grade3
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 52, Grade4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 52, Grade5
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 56, Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 56, Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 56, Grade 5
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 60, Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 60, Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 60, Grade 5
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 64, Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 64, Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 64, Grade 5
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 68, Grade3
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 68, Grade4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 68, Grade5
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 72, Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 72, Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 72, Grade 5
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 76, Grade3
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 76, Grade4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 76, Grade5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 80, Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 80, Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 80, Grade 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 84, Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 84, Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 84, Grade 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 88, Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 88, Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 88, Grade 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 116, Grade 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 92, Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 92, Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 92, Grade 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 96, Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 120, Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 120, Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 120, Grade 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 124, Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 124, Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 124, Grade 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 128, Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 128, Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 128, Grade 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 132, Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 132, Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 132, Grade 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 136, Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 136, Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 136, Grade 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 140, Grade 3
|
2 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 140, Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 140, Grade 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 144, Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 144, Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 144, Grade 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 148, Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 148, Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Week 148, Grade 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Withdrawal/Study conclusion, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Withdrawal/Study conclusion, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Withdrawal/Study conclusion, Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: withdrawal/study completion, up to approx. 3.5 yearsPopulation: Safety Population: all participants who were randomized and received at least one dose of investigational product.
Number of participants who received any concomitant medication along with study drugs (lapatinib, trastuzumab and paclitaxel) were counted during the treatment period.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=29 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Number of Participants Who Received Any Concomitant Medications During the Study Period
|
29 Participants
|
14 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: From the date of the first dose of investigational product to end of study, up to approx. 7 yearsPopulation: Safety Population: all participants who were randomized and received at least one dose of investigational product.
OR is defined as the number of participants achieving either a CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST). The best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made \>=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=29 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Overall Response (OR): Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the Investigator
|
79.3 Percentage of participants
Interval 64.6 to 94.1
|
71.4 Percentage of participants
Interval 47.8 to 95.1
|
70.0 Percentage of participants
Interval 49.9 to 90.1
|
SECONDARY outcome
Timeframe: From the date of the first dose of investigational product until the first documented evidence of a PR or CR, up to approx. 7 yearsPopulation: Safety Population. Safety Population: all participants who were randomized and received at least one dose of investigational product. Only those participants with CR or PR were analyzed.
Time to Response was defined for subjects who had a confirmed CR or PR as the time from first dose until first documented evidence of partial or complete tumour response (whichever status was recorded first). CR is defined as the disappearance of all TLs \& non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=23 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=10 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=14 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Time to Response as Assessed by the Investigator
Week 8
|
15 Participants
|
8 Participants
|
8 Participants
|
|
Time to Response as Assessed by the Investigator
Week 12
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Time to Response as Assessed by the Investigator
Week 16
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Time to Response as Assessed by the Investigator
Week 20
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Time to Response as Assessed by the Investigator
Week 24
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Time to Response as Assessed by the Investigator
Week 28
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer, up to approx. 7 yearsPopulation: Safety Population. Safety Population: all participants who were randomized and received at least one dose of investigational product. Only those participants with CR or PR were analyzed.
DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (\>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL\[s\]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as \>=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=29 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Duration of Response (DoR), as Assessed by the Investigator
|
56.6 Weeks
Interval 27.6 to 117.7
|
59.0 Weeks
Interval 33.1 to 88.7
|
70.6 Weeks
Interval 31.4 to 103.1
|
SECONDARY outcome
Timeframe: From the date of the first dose of investigational product until the first documented evidence of a PR or CR or SD until the earlier of the date of disease progression or the date of death due to breast cancer, up to approx. 7 yearsPopulation: Safety Population. Safety Population: all participants who were randomized and received at least one dose of investigational product. Only those participants with CR, PR and SD for at least 24 weeks were analyzed.
Clinical benefit is defined as the percentage of participants achieving either a CR or PR or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least a 20% increase in the sum of the LD of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions), taking as reference, the smallest sum LD since the treatment started) for at least 24 weeks. This was based on confirmed responses from the investigator assessment of clinical benefit.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=29 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Percentage of Participants With Clinical Benefit (Complete Response (CR), Partial Response (PR), and Stable Disease [SD] for at Least 24 Weeks) as Assessed by Investigator
|
79.3 Percentage of Participants
Interval 64.6 to 94.1
|
71.4 Percentage of Participants
Interval 47.8 to 95.1
|
70.0 Percentage of Participants
Interval 49.9 to 90.1
|
SECONDARY outcome
Timeframe: From the date of the first dose of investigational product until the earlier of the date of disease progression or death due to any cause, up to approx. 7 yearsPopulation: Safety Population: all participants who were randomized and received at least one dose of investigational product. Only those participants with CR, PR and SD for at least 24 weeks were analyzed.
Progression-free survival is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. Disease progression was based on the investigator's assessments of the objective evidence (e.g., radiological scans and medical photographs). For participants who do not progress, or die, progression-free survival was censored at the time of the last investigator assessed radiological scan preceding the initiation of any alternative anti-cancer therapy. Progression-free survival was summarized using Kaplan-Meier curves.
Outcome measures
| Measure |
Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=29 Participants
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 Participants
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 Participants
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Progression-free Survival as Assessed by the Investigator
|
64.7 Weeks
Interval 33.1 to 117.0
|
55.0 Weeks
Interval 20.4 to 96.1
|
78.4 Weeks
Interval 31.9 to 111.0
|
Adverse Events
Cohort 1: Paclitaxel 80mg/Trastuzumab 4 mg/Lapatinib 1000mg
Serious events: 14 serious events
Other events: 29 other events
Deaths: 0 deaths
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Paclitaxel 80mg/Trastuzumab 4 mg/Lapatinib 1000mg
n=29 participants at risk
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 participants at risk
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 participants at risk
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Cardiac disorders
Left ventricular dysfunction
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
General disorders
Fatigue
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
General disorders
Mucosal inflammation
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
General disorders
Pyrexia
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Cellulitis streptococcal
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Clostridium difficile colitis
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Infectious colitis
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Investigations
Ejection fraction decreased
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
17.2%
5/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Renal and urinary disorders
Renal failure
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
Other adverse events
| Measure |
Cohort 1: Paclitaxel 80mg/Trastuzumab 4 mg/Lapatinib 1000mg
n=29 participants at risk
Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m\^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
|
Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg
n=14 participants at risk
Participants received an IV infusion of paclitaxel 70 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m\^2 after 2 cycles if 70 mg/m\^2 was tolerated.
|
Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg
n=20 participants at risk
Participants received an IV infusion of paclitaxel 80 mg/m\^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
|
|---|---|---|---|
|
General disorders
Mucosal inflammation
|
27.6%
8/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
42.9%
6/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
10.0%
2/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
28.6%
4/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
10.0%
2/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
General disorders
Oedema peripheral
|
17.2%
5/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
28.6%
4/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
37.9%
11/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
15.0%
3/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Leukopenia
|
17.2%
5/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.8%
4/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
20.0%
4/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Cardiac disorders
Left ventricular dysfunction
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Ear and labyrinth disorders
Ear pain
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
10.0%
2/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Eye disorders
Eye irritation
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Eye disorders
Lacrimation increased
|
10.3%
3/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
10.0%
2/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Eye disorders
Ocular hyperaemia
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Eye disorders
Vision blurred
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Eye disorders
Visual impairment
|
10.3%
3/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.2%
5/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
15.0%
3/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
13.8%
4/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
21.4%
3/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Constipation
|
24.1%
7/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
50.0%
7/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
25.0%
5/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
96.6%
28/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
92.9%
13/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
75.0%
15/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
24.1%
7/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
21.4%
3/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
10.0%
2/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Dysphagia
|
10.3%
3/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Flatulence
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
13.8%
4/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
15.0%
3/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Nausea
|
55.2%
16/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
78.6%
11/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
65.0%
13/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
10.0%
2/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Stomatitis
|
27.6%
8/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
21.4%
3/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
30.0%
6/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Toothache
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
58.6%
17/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
42.9%
6/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
20.0%
4/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
General disorders
Asthenia
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
General disorders
Chest pain
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
General disorders
Chills
|
13.8%
4/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
General disorders
Fatigue
|
72.4%
21/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
85.7%
12/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
65.0%
13/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
General disorders
Pain
|
13.8%
4/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
21.4%
3/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
20.0%
4/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
General disorders
Peripheral swelling
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
General disorders
Pyrexia
|
20.7%
6/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
35.7%
5/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
25.0%
5/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
10.0%
2/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Immune system disorders
Hypersensitivity
|
10.3%
3/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Immune system disorders
Seasonal allergy
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Bronchitis
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Candida infection
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Cellulitis
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Cystitis
|
10.3%
3/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Ear infection
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Fungal skin infection
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
10.0%
2/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Infection
|
10.3%
3/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Laryngitis
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Localised infection
|
17.2%
5/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Nail infection
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
10.0%
2/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Paronychia
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Pneumonia
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Sinusitis
|
10.3%
3/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
21.4%
3/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Skin infection
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
27.6%
8/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
42.9%
6/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
15.0%
3/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
17.2%
5/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
21.4%
3/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
10.0%
2/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Vaginal infection
|
10.3%
3/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
10.3%
3/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Investigations
Blood alkaline phosphatase increased
|
13.8%
4/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Investigations
Blood creatinine increased
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Investigations
Blood potassium decreased
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Investigations
Ejection fraction decreased
|
20.7%
6/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Investigations
Haemoglobin decreased
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
10.0%
2/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Investigations
Lymphocyte count decreased
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Investigations
Neutrophil count decreased
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Investigations
Weight decreased
|
24.1%
7/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
21.4%
3/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Investigations
Weight increased
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Investigations
White blood cell count decreased
|
10.3%
3/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
15.0%
3/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Investigations
White blood cell count increased
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
27.6%
8/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
15.0%
3/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
27.6%
8/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
17.2%
5/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
41.4%
12/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
21.4%
3/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
10.0%
2/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.3%
3/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
13.8%
4/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.7%
6/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
30.0%
6/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.2%
5/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
21.4%
3/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
15.0%
3/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.3%
3/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.3%
3/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
15.0%
3/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.8%
4/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
37.9%
11/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
21.4%
3/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
20.0%
4/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
17.2%
5/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
24.1%
7/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
21.4%
3/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
25.0%
5/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Nervous system disorders
Dizziness
|
17.2%
5/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
21.4%
3/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
20.0%
4/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Nervous system disorders
Dysgeusia
|
10.3%
3/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
10.0%
2/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Nervous system disorders
Headache
|
27.6%
8/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
35.7%
5/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
25.0%
5/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Nervous system disorders
Hypoaesthesia
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Nervous system disorders
Neuropathy peripheral
|
17.2%
5/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
42.9%
6/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
20.0%
4/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Nervous system disorders
Paraesthesia
|
24.1%
7/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
25.0%
5/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.7%
6/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
15.0%
3/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Nervous system disorders
Syncope
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Nervous system disorders
Toxic neuropathy
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Psychiatric disorders
Anxiety
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
21.4%
3/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
10.0%
2/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Psychiatric disorders
Confusional state
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Psychiatric disorders
Depression
|
10.3%
3/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
21.4%
3/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Psychiatric disorders
Insomnia
|
20.7%
6/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
50.0%
7/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
15.0%
3/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Renal and urinary disorders
Dysuria
|
10.3%
3/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Reproductive system and breast disorders
Breast pain
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
41.4%
12/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
21.4%
3/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
20.0%
4/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.2%
5/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
42.9%
6/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
20.0%
4/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
34.5%
10/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.7%
6/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
21.4%
3/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
31.0%
9/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
25.0%
5/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
10.3%
3/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
75.9%
22/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
57.1%
8/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
55.0%
11/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.2%
5/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
21.4%
3/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
15.0%
3/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
24.1%
7/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
42.9%
6/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
15.0%
3/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.7%
6/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
35.7%
5/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
15.0%
3/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
86.2%
25/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
64.3%
9/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
85.0%
17/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Surgical and medical procedures
Mastectomy
|
3.4%
1/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
10.0%
2/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Surgical and medical procedures
Prophylaxis
|
0.00%
0/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Vascular disorders
Flushing
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Vascular disorders
Hot flush
|
17.2%
5/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
14.3%
2/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
15.0%
3/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Vascular disorders
Hypotension
|
6.9%
2/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
0.00%
0/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
|
Vascular disorders
Lymphoedema
|
13.8%
4/29 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
7.1%
1/14 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
5.0%
1/20 • Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
|
Additional Information
Clinical Disclosure Office
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER