Trial Outcomes & Findings for Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer (NCT NCT00374322)
NCT ID: NCT00374322
Last Updated: 2014-08-18
Results Overview
DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ; other second primary cancer (excluding squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast); death from any cause without a prior event. Par. who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Par. who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3166 participants
Primary outcome timeframe
From randomization until date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause (assessed up to 6 years; 1 year of treatment, 5 years of follow-up [median of 5.3 years for final analysis])
Results posted on
2014-08-18
Participant Flow
Women with early-stage ErbB2-overexpressing breast cancer who had not been previously treated with trastuzumab were enrolled in this Phase III study. Women who subsequently had no clinical or radiologic evidence of disease were enrolled after completion of primary neoadjuvant/adjuvant chemotherapy.
The study consisted of a Screening Period, a 1-year Treatment Period, and a Follow-up (FU) Period of up to 5 years after the date of study drug withdrawal/completion, for disease status/survival. A total of 3161 eligible participants (par.) (of the 3166 enrolled) were randomized, out of which 3147 par. received at least one dose of study treatment.
Participant milestones
| Measure |
Lapatinib 1500 mg
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
|---|---|---|
|
Overall Study
STARTED
|
1579
|
1582
|
|
Overall Study
Received >=1 Dose of Study Treatment
|
1571
|
1576
|
|
Overall Study
COMPLETED
|
322
|
278
|
|
Overall Study
NOT COMPLETED
|
1257
|
1304
|
Reasons for withdrawal
| Measure |
Lapatinib 1500 mg
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
92
|
90
|
|
Overall Study
Protocol Violation
|
8
|
3
|
|
Overall Study
Withdrawal by Subject
|
235
|
167
|
|
Overall Study
Sponsor Terminated Study
|
866
|
990
|
|
Overall Study
Physician Decision
|
36
|
32
|
|
Overall Study
Par. Consented to Survival FU Only
|
3
|
1
|
|
Overall Study
Sponsor Decision
|
2
|
3
|
|
Overall Study
FU by a Non-Principal Investigator (PI)
|
2
|
3
|
|
Overall Study
Seen in FU by a Non-Primary Investigator
|
1
|
0
|
|
Overall Study
Severe Toxicity
|
1
|
0
|
|
Overall Study
Site Closed
|
2
|
2
|
|
Overall Study
Participant Changed Physician
|
1
|
0
|
|
Overall Study
Started Another Chemotherapy Regimen
|
0
|
1
|
|
Overall Study
Noncompliance with Study Requirements
|
0
|
1
|
|
Overall Study
Withdrew Consent During Follow-up
|
0
|
5
|
|
Overall Study
Did Not Receive Study Medication
|
8
|
6
|
Baseline Characteristics
Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer
Baseline characteristics by cohort
| Measure |
Lapatinib 1500 mg
n=1571 Participants
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
n=1576 Participants
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Total
n=3147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.7 Years
STANDARD_DEVIATION 9.89 • n=5 Participants
|
52.3 Years
STANDARD_DEVIATION 9.94 • n=7 Participants
|
52.0 Years
STANDARD_DEVIATION 9.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1571 Participants
n=5 Participants
|
1576 Participants
n=7 Participants
|
3147 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/ African Heritage
|
53 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
65 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
236 Participants
n=5 Participants
|
229 Participants
n=7 Participants
|
465 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
81 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
1126 Participants
n=5 Participants
|
1121 Participants
n=7 Participants
|
2247 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization until date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause (assessed up to 6 years; 1 year of treatment, 5 years of follow-up [median of 5.3 years for final analysis])Population: Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of randomized treatment (lapatinib or placebo). Data for the end-of-study analysis (conducted in 2013) are reported.
DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ; other second primary cancer (excluding squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast); death from any cause without a prior event. Par. who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Par. who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=1571 Participants
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
n=1576 Participants
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
|---|---|---|
|
Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])
Any recurrence or death
|
252 Participants
|
290 Participants
|
|
Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])
Censored, New Anti-cancer Agent/Radiotherapy
|
1 Participants
|
1 Participants
|
|
Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])
Censored, Follow-up Ended
|
1318 Participants
|
1285 Participants
|
SECONDARY outcome
Timeframe: From the date of randomization until death from any cause (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis])Population: ITT Population. Data for the primary analysis (conducted in 2011) are reported.
Overall Survival (OS) is defined as the time from randomization until death from any cause. Data are presented as the number of participants who died. For participants who did not die, time to death was censored at the last date the participant was known to be alive.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=1571 Participants
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
n=1576 Participants
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
|---|---|---|
|
Number of Participants Who Died (Overall Survival)
Censored, Follow-up Ended
|
1456 Participants
|
1450 Participants
|
|
Number of Participants Who Died (Overall Survival)
Died
|
115 Participants
|
126 Participants
|
SECONDARY outcome
Timeframe: From the date of randomization until the date of the first occurrence of an objective disease recurrence or contralateral breast cancer (assessed up to 6 years; 1 year of treatment and 5.3 years of follow-up [median of 5 years for final analysis])Population: ITT Population. Data for the primary analysis (conducted in 2011) are reported.
Recurrence is defined as experiencing a recurrence of initial disease or contralateral breast cancer after randomization. Time to first recurrence is defined as the interval between the date of randomization and the date of the first occurrence of an objective disease recurrence or contralateral breast cancer. Time to first recurrence included the first occurrence at one of the following sites as an event: local recurrence following mastectomy; local recurrence in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ (DCIS).
Outcome measures
| Measure |
Lapatinib 1500 mg
n=1571 Participants
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
n=1576 Participants
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
|---|---|---|
|
Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence)
6 Months
|
1.3 Percentage of participants
|
2.8 Percentage of participants
|
|
Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence)
1Year
|
3.7 Percentage of participants
|
5.4 Percentage of participants
|
|
Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence)
18 Months
|
5.6 Percentage of participants
|
8.2 Percentage of participants
|
|
Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence)
2 Years
|
7.7 Percentage of participants
|
9.9 Percentage of participants
|
|
Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence)
3 Years
|
10.6 Percentage of participants
|
12.6 Percentage of participants
|
|
Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence)
4 Years
|
13.3 Percentage of participants
|
15.8 Percentage of participants
|
|
Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence)
5 Years
|
NA Percentage of participants
There was not sufficient follow-up to allow reasonable estimation of recurrence rates at time points beyond 5 years, when this analysis was carried out at the primary time point.
|
24.9 Percentage of participants
|
SECONDARY outcome
Timeframe: From the date of randomization until the date of the first occurrence of a distant recurrence (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis])Population: ITT Population. Data for the primary analysis (conducted in 2011) are reported.
Distant recurrence (metastatic disease) is defined as a tumor in any area of the body not including those defined as local or regional recurrence. Sites of distant recurrence include: skin, subcutaneous tissue, and lymph nodes (excluding those described for local and regional recurrence); bone marrow; skeletal; lungs and pleural; ascites and pleural effusions; liver and other viscera; and central nervous system (CNS). Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a distant recurrence.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=1571 Participants
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
n=1576 Participants
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
|---|---|---|
|
Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence)
6 Months
|
0.9 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence)
1Year
|
2.9 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence)
18 Months
|
4.3 Percentage of participants
|
6.0 Percentage of participants
|
|
Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence)
2 Years
|
5.9 Percentage of participants
|
7.2 Percentage of participants
|
|
Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence)
3 Years
|
8.1 Percentage of participants
|
9.1 Percentage of participants
|
|
Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence)
4 Years
|
9.3 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence)
5 Years
|
NA Percentage of participants
There was not sufficient follow-up to allow reasonable estimation of recurrence rates at time points beyond 5 years, when this analysis was carried out at the primary time point.
|
14.2 Percentage of participants
|
SECONDARY outcome
Timeframe: From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis])Time to CNS recurrence is defined as the interval between the date of randomization and the date of the occurrence of a CNS recurrence if noted as part of the participant's first recurrence. Time to CNS recurrence was not calculated; data are presented as the number of participants with CNS recurrence in the subsequent outcome measure table.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis])Population: ITT Population. Data for the end-of-study analysis (conducted in 2013) are reported.
The number of participants experiencing a CNS recurrence was summarized.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=1571 Participants
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
n=1576 Participants
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
|---|---|---|
|
Number of Participants With CNS Recurrence
|
15 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years)Modified disease recurrence=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause. The date of the event=the earliest date of the occurrence of any of the following events: local recurrence following mastectomy; local recurrence in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including DCIS; death from any cause without a prior event. MDFS was not calculated; data are presented as the number of participants with any recurrence of the initial disease, contralateral breast cancer, or death (disease-free survival) in the subsequent outcome measure table.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years)Population: ITT Population. Data for the end-of-study analysis (conducted in 2013) are reported.
DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence and contralateral breast cancer, including ductal carcinoma in situ; or death from any cause without a prior event. Participants who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Participants who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=1571 Participants
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
n=1576 Participants
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
|---|---|---|
|
Number of Participants With Any Recurrence of the Initial Disease, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])
|
184 Participants
|
231 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)Population: ITT Population (primary analysis \[conducted in 2011\]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed.
The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The PCS score is a summary score representing overall physical health, which is derived from the 8 domain scores. As with each domain score, the PCS score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the last observation carried forward (LOCF) method. The scores were analyzed using an analysis of covariance (ANCOVA) model, adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=1092 Participants
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
n=1283 Participants
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
|---|---|---|
|
Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS)
Month 6, n=1092, 1283
|
-0.78 Scores on a scale
Standard Error 0.217
|
-0.44 Scores on a scale
Standard Error 0.211
|
|
Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS)
Month 12, n=1007, 1204
|
-0.84 Scores on a scale
Standard Error 0.251
|
-0.54 Scores on a scale
Standard Error 0.242
|
|
Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS)
Follow-up, Month 6, n= 983, 1074
|
-0.53 Scores on a scale
Standard Error 0.287
|
-0.87 Scores on a scale
Standard Error 0.281
|
|
Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS)
Follow-up, Month 12, n= 940, 988
|
-0.88 Scores on a scale
Standard Error 0.290
|
-0.82 Scores on a scale
Standard Error 0.289
|
|
Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS)
Follow-up, Month 18, n=834, 889
|
-0.61 Scores on a scale
Standard Error 0.350
|
-0.89 Scores on a scale
Standard Error 0.346
|
|
Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS)
Follow-up, Month 24, n=807, 824
|
-0.99 Scores on a scale
Standard Error 0.412
|
-0.66 Scores on a scale
Standard Error 0.417
|
|
Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS)
Early inv. product discontinuation, n=289, 120
|
-4.39 Scores on a scale
Standard Error 0.712
|
-4.00 Scores on a scale
Standard Error 0.886
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)Population: ITT Population (primary analysis \[conducted in 2011\]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed.
The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The MCS score is a summary score representing overall mental health, which is derived from the 8 domain scores. As with each domain score, the MCS score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the LOCF method. The scores were analyzed using an ANCOVA model adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=1092 Participants
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
n=1283 Participants
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
|---|---|---|
|
Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS)
Month 6, n=1092, 1283
|
-2.34 Scores on a scale
Standard Error 0.306
|
-1.74 Scores on a scale
Standard Error 0.297
|
|
Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS)
Month 12, n=1007, 1204
|
-2.74 Scores on a scale
Standard Error 0.332
|
-2.29 Scores on a scale
Standard Error 0.322
|
|
Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS)
Follw-up, Month 6, n=983, 1074
|
-2.22 Scores on a scale
Standard Error 0.368
|
-1.87 Scores on a scale
Standard Error 0.361
|
|
Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS)
Follow-up, Month 12, n= 940, 988
|
-3.08 Scores on a scale
Standard Error 0.393
|
-2.76 Scores on a scale
Standard Error 0.392
|
|
Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS)
Follow-up, Month 18, n=834, 889
|
-2.38 Scores on a scale
Standard Error 0.480
|
-2.08 Scores on a scale
Standard Error 0.475
|
|
Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS)
Follow-up, Month 24, n=807, 824
|
-2.78 Scores on a scale
Standard Error 0.547
|
-3.05 Scores on a scale
Standard Error 0.554
|
|
Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS)
Early inv. product discontinuation, n=289, 120
|
-6.65 Scores on a scale
Standard Error 0.985
|
-8.11 Scores on a scale
Standard Error 1.221
|
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)Population: ITT Population (primary analysis \[conducted in 2011\]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed.
The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) perceptions, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). Each domain is scored from 0 (poorer health) to 100 (better health); higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the LOCF method. The scores were analyzed using an ANCOVA model, adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=1132 Participants
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
n=1345 Participants
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
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|---|---|---|
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Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
RP, Follow-up, Month 18, n=851, 909
|
-1.72 Scores on a scale
Standard Error 0.410
|
-1.68 Scores on a scale
Standard Error 0.405
|
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Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
GH, Follow-up, Month 24, n=813, 835
|
-1.29 Scores on a scale
Standard Error 0.471
|
-1.02 Scores on a scale
Standard Error 0.476
|
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Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
PF, Month 6, n=1132, 1345
|
-0.52 Scores on a scale
Standard Error 0.235
|
-0.65 Scores on a scale
Standard Error 0.227
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
PF, Month 12, n=1025, 1234
|
-0.59 Scores on a scale
Standard Error 0.269
|
-0.91 Scores on a scale
Standard Error 0.260
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
PF, Follow-up, Month 6, n=997, 1097
|
-0.45 Scores on a scale
Standard Error 0.296
|
-0.81 Scores on a scale
Standard Error 0.289
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
PF, Follow-up, Month 12, n=955, 1013
|
-1.11 Scores on a scale
Standard Error 0.317
|
-1.40 Scores on a scale
Standard Error 0.316
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
PF, Follow-up, Month 18, n=851, 913
|
-0.80 Scores on a scale
Standard Error 0.363
|
-1.10 Scores on a scale
Standard Error 0.358
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
PF, Follow-up, Month 24, n=818, 845
|
-1.06 Scores on a scale
Standard Error 0.438
|
-1.17 Scores on a scale
Standard Error 0.442
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
PF, Early inv. Product discontinuation, n=304, 128
|
-4.30 Scores on a scale
Standard Error 0.755
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-4.43 Scores on a scale
Standard Error 0.928
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
RP, Month 6, n=1130, 1335
|
-1.37 Scores on a scale
Standard Error 0.276
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-0.87 Scores on a scale
Standard Error 0.267
|
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Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
RP, Month 12, n=1023, 1230
|
-1.52 Scores on a scale
Standard Error 0.303
|
-0.83 Scores on a scale
Standard Error 0.293
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
RP, Follow-up, Month 6, n=997, 1094
|
-1.14 Scores on a scale
Standard Error 0.328
|
-1.45 Scores on a scale
Standard Error 0.322
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
RP, Follow-up, Month 12, n=955, 1009
|
-1.78 Scores on a scale
Standard Error 0.344
|
-1.47 Scores on a scale
Standard Error 0.343
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
RP, Follow-up, Month 24, n=818, 842
|
-1.77 Scores on a scale
Standard Error 0.486
|
-1.54 Scores on a scale
Standard Error 0.491
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
RP, Early inv. product discontinuation, n=303, 127
|
-6.96 Scores on a scale
Standard Error 0.882
|
-7.09 Scores on a scale
Standard Error 1.087
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
BP, Month 6, n=1130, 1331
|
-1.58 Scores on a scale
Standard Error 0.304
|
-1.31 Scores on a scale
Standard Error 0.295
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
BP, Month 12, n=1024, 1229
|
-1.75 Scores on a scale
Standard Error 0.338
|
-1.62 Scores on a scale
Standard Error 0.326
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
BP, Follow-up, Month 6, n=995, 1094
|
-1.13 Scores on a scale
Standard Error 0.376
|
-1.35 Scores on a scale
Standard Error 0.368
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
BP, Follow-up, Month 12, n=954, 1007
|
-1.06 Scores on a scale
Standard Error 0.383
|
-1.19 Scores on a scale
Standard Error 0.382
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
BP, Follow-up, Month 18, n=847, 909
|
-0.69 Scores on a scale
Standard Error 0.461
|
-1.07 Scores on a scale
Standard Error 0.455
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
BP, Follow-up, Month 24, n=817, 840
|
-1.69 Scores on a scale
Standard Error 0.547
|
-1.41 Scores on a scale
Standard Error 0.553
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
BP, Early inv. product discontinuation, n=302, 126
|
-4.92 Scores on a scale
Standard Error 0.950
|
-4.97 Scores on a scale
Standard Error 1.164
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
GH, Month 6, n=1124, 1319
|
-1.01 Scores on a scale
Standard Error 0.244
|
-0.34 Scores on a scale
Standard Error 0.236
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
GH, Month 12, n=1020, 1221
|
-1.33 Scores on a scale
Standard Error 0.275
|
-0.70 Scores on a scale
Standard Error 0.266
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
GH, Follow-up, Month 6, n=994, 1085
|
-1.25 Scores on a scale
Standard Error 0.314
|
-1.34 Scores on a scale
Standard Error 0.308
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
GH, Follow-up, Month 12, n=951, 1002
|
-1.93 Scores on a scale
Standard Error 0.330
|
-1.48 Scores on a scale
Standard Error 0.329
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
GH, Follow-up, Month 18, n=844, 902
|
-1.28 Scores on a scale
Standard Error 0.397
|
-1.28 Scores on a scale
Standard Error 0.392
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
SF, Follow-up, Month 18, n=850, 912
|
-1.96 Scores on a scale
Standard Error 0.462
|
-2.01 Scores on a scale
Standard Error 0.456
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
SF, Follow-up, Month 24, n=819, 843
|
-2.94 Scores on a scale
Standard Error 0.526
|
-2.75 Scores on a scale
Standard Error 0.532
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
SF, Early inv. product discontinuation, n=305, 127
|
-7.05 Scores on a scale
Standard Error 1.017
|
-7.94 Scores on a scale
Standard Error 1.247
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
RE, Month 6, n=1124, 1328
|
-1.80 Scores on a scale
Standard Error 0.335
|
-1.69 Scores on a scale
Standard Error 0.325
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
RE, Month 12, n=1023, 1226
|
-1.99 Scores on a scale
Standard Error 0.357
|
-1.99 Scores on a scale
Standard Error 0.345
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
RE, Follow-up, Month 6, n=996, 1091
|
-1.87 Scores on a scale
Standard Error 0.393
|
-1.88 Scores on a scale
Standard Error 0.385
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
RE, Follow-up, Month 12, n=955, 1004
|
-2.88 Scores on a scale
Standard Error 0.425
|
-2.72 Scores on a scale
Standard Error 0.425
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
RE, Follow-up,Month 18, n=851, 905
|
-2.47 Scores on a scale
Standard Error 0.509
|
-2.50 Scores on a scale
Standard Error 0.503
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
RE, Follow-up,Month 24, n=818, 839
|
-2.75 Scores on a scale
Standard Error 0.582
|
-2.95 Scores on a scale
Standard Error 0.589
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
RE, Early inv. product discontinuation, n=303, 126
|
-6.85 Scores on a scale
Standard Error 1.020
|
-8.00 Scores on a scale
Standard Error 1.258
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
MH, Month 6, n=1124, 1332
|
-1.96 Scores on a scale
Standard Error 0.303
|
-1.46 Scores on a scale
Standard Error 0.293
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
MH, Month 12, n=1021, 1225
|
-2.38 Scores on a scale
Standard Error 0.333
|
-2.11 Scores on a scale
Standard Error 0.322
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
MH, Follow-up, Month 6, n=993, 1090
|
-1.92 Scores on a scale
Standard Error 0.367
|
-1.70 Scores on a scale
Standard Error 0.360
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
MH, Follow-up, Month 12, n=953, 1006
|
-2.47 Scores on a scale
Standard Error 0.390
|
-2.47 Scores on a scale
Standard Error 0.389
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
MH, Follow-up, Month 18, n=848, 906
|
-1.91 Scores on a scale
Standard Error 0.469
|
-1.58 Scores on a scale
Standard Error 0.464
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
MH, Follow-up, Month 24, n=817, 837
|
-2.16 Scores on a scale
Standard Error 0.545
|
-2.54 Scores on a scale
Standard Error 0.552
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
MH, Early inv. product discontinuation, n=303, 125
|
-5.96 Scores on a scale
Standard Error 0.964
|
-7.87 Scores on a scale
Standard Error 1.187
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
GH, Early inv. product discontinuation, n=299, 124
|
-5.12 Scores on a scale
Standard Error 0.775
|
-6.30 Scores on a scale
Standard Error 0.965
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
VT, Month 6, n=1126, 1332
|
-2.30 Scores on a scale
Standard Error 0.283
|
-1.83 Scores on a scale
Standard Error 0.274
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
VT, Month 12, n=1022, 1225
|
-2.49 Scores on a scale
Standard Error 0.309
|
-1.88 Scores on a scale
Standard Error 0.299
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
VT, Follow-up, Month 6, n=993, 1090
|
-1.55 Scores on a scale
Standard Error 0.335
|
-1.61 Scores on a scale
Standard Error 0.328
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
VT, Follow-up, Month 12, n=953, 1006
|
-2.45 Scores on a scale
Standard Error 0.355
|
-2.01 Scores on a scale
Standard Error 0.354
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
VT, Follow-up, Month 18, n=848, 906
|
-1.53 Scores on a scale
Standard Error 0.426
|
-1.25 Scores on a scale
Standard Error 0.421
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
VT, Follow-up, Month 24, n=817, 837
|
-2.03 Scores on a scale
Standard Error 0.501
|
-1.96 Scores on a scale
Standard Error 0.507
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
VT, Early inv. product discontinuation, n=303, 125
|
-5.54 Scores on a scale
Standard Error 0.867
|
-5.78 Scores on a scale
Standard Error 1.067
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
SF, Month 6, n=1138, 1347
|
-2.34 Scores on a scale
Standard Error 0.299
|
-1.42 Scores on a scale
Standard Error 0.289
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
SF, Month 12, n=1025, 1234
|
-2.63 Scores on a scale
Standard Error 0.333
|
-2.05 Scores on a scale
Standard Error 0.322
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
SF, Follow-up, Month 6, n=997, 1098
|
-1.80 Scores on a scale
Standard Error 0.371
|
-1.51 Scores on a scale
Standard Error 0.363
|
|
Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
SF, Follow-up, Month 12, n=957, 1011
|
-2.47 Scores on a scale
Standard Error 0.383
|
-2.17 Scores on a scale
Standard Error 0.382
|
SECONDARY outcome
Timeframe: At Baseline and every 3 months thereafter up to Month 12/Early Withdrawal VisitPopulation: Safety Population (SP): all randomized participants (par.) who received \>=1 dose of randomized treatment. Only those par. available (n=X, X in the category titles) at the specified time points were analyzed. Different par. may have been analyzed for different parameters, so the overall number of par. analyzed reflects everyone in the SP.
The hematology parameters assessed were: basophils (Bs) in giga (10\^9) per liter (GI/L) and in percentage (%), eosinophils (Eo) in GI/L and %, hematocrit, hemoglobin, lymphocytes (Lmph) in GI/L and %, monocytes (Mono) in GI/L and %, platelet count, Red Blood Cell (RBC) count, total neutrophil count (TNC) in GI/L and %, and White Blood Cell (WBC) count. The Baseline (BL) value is the last available pre-treatment result recorded. "Any post-Baseline value" was based on results recorded at any scheduled or unscheduled post-Baseline visits. The prevalence of values lying outside the reference (ref.) range (high or low) is presented for BL and "any post-Baseline" (APBL) visit. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=1573 Participants
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
n=1574 Participants
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
|---|---|---|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Bs (GI/L), BL, ref. range high, n=1555, 1563
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Bs (GI/L), BL, ref. range low, n=1555, 1563
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Bs (GI/L), APBL, ref. range high, n=1466, 1537
|
7 Participants
|
7 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Bs (GI/L), APBL, ref. range low, n=1466, 1537
|
7 Participants
|
2 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Eo (GI/L), BL, ref. range high, n=1557, 1562
|
34 Participants
|
35 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Eo (GI/L), BL, ref. range low, n=1557, 1562
|
242 Participants
|
184 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Eo (GI/L), APBL, ref. range high, n=1466, 1537
|
84 Participants
|
75 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Eo (GI/L), APBL, ref. range low, n=1466, 1537
|
322 Participants
|
370 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Hematocrit, BL, ref. range high, n=1560, 1563
|
20 Participants
|
30 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Hematocrit, BL, ref. range low, n=1560, 1563
|
72 Participants
|
96 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Hematocrit, APBL, ref. range high, n=1474, 1538
|
46 Participants
|
65 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Hematocrit, APBL, ref. range low, n=1474, 1538
|
196 Participants
|
145 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Hemoglobin, BL, ref. range high, n=1560, 1563
|
8 Participants
|
16 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Hemoglobin, BL, ref. range low, n=1560, 1563
|
148 Participants
|
160 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Hemoglobin, APBL, ref. range high, n=1474, 1538
|
32 Participants
|
34 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Hemoglobin, APBL, ref. range low, n=1474, 1538
|
295 Participants
|
212 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Lmph (GI/L), BL, ref. range high, n=1557, 1562
|
5 Participants
|
1 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Lmph (GI/L), BL, ref. range low, n=1557, 1562
|
80 Participants
|
89 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Lmph (GI/L), APBL, ref. range high, n=1468, 1538
|
12 Participants
|
11 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Lmph (GI/L), APBL, ref. range low, n=1468, 1538
|
106 Participants
|
100 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Mono (GI/L), BL, ref. range high, n=1557, 1562
|
2 Participants
|
4 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Mono (GI/L), BL, ref. range low, n=1557, 1562
|
236 Participants
|
239 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Mono (GI/L), APBL, ref. range high, n=1466, 1538
|
7 Participants
|
7 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Mono (GI/L), APBL, ref. range low, n=1466, 1538
|
425 Participants
|
431 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Platelet count, BL, ref. range high, n=1553, 1559
|
34 Participants
|
33 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Platelet count, BL, ref. range low, n=1553, 1559
|
21 Participants
|
15 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Platelet count, APBL, ref. range high, n=1473, 153
|
95 Participants
|
56 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Platelet count, APBL, ref. range low, n=1473, 1538
|
40 Participants
|
37 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
RBC count, BL, ref. range high, n=1559, 1563
|
10 Participants
|
18 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
RBC count, BL, ref. range low, n=1559, 1563
|
144 Participants
|
148 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
RBC count, APBL, ref. range high, n=1474, 1538
|
25 Participants
|
36 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
RBC count, APBL, ref. range low, n=1474, 1538
|
270 Participants
|
207 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
TNC (GI/L), BL, ref. range high, n=1557, 1563
|
17 Participants
|
15 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
TNC (GI/L), BL, ref. range low, n=1557, 1563
|
47 Participants
|
41 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
TNC (GI/L), APBL, ref. range high, n=1469, 1538
|
38 Participants
|
53 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
TNC (GI/L), APBL, ref. range low, n=1469, 1538
|
115 Participants
|
161 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
WBC count, BL, ref. range high, n=1559, 1563
|
18 Participants
|
14 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
WBC count, BL, ref. range low, n=1559, 1563
|
142 Participants
|
104 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
WBC count, APBL, ref. range high, n=1471, 1537
|
42 Participants
|
57 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
WBC count, APBL, ref. range low, n=1471, 1537
|
191 Participants
|
198 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Bs (%), BL, ref. range high, n=64, 55
|
8 Participants
|
4 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Bs (%), BL, ref. range low, n=64, 55
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Bs (%), APBL, ref. range high, n=131, 131
|
17 Participants
|
18 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Bs (%), APBL, ref. range low, n=131, 131
|
4 Participants
|
1 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Eo (%), BL, ref. range high, n=65, 55
|
7 Participants
|
9 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Eo (%), BL, ref. range low, n=65, 55
|
2 Participants
|
1 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Eo (%), APBL, ref. range high, n=135, 132
|
16 Participants
|
20 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Eo (%), APBL, ref. range low, n=135, 132
|
9 Participants
|
4 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Lmph (%), BL, ref. range high, n=68, 57
|
4 Participants
|
3 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Lmph (%), BL, ref. range low, n=68, 57
|
10 Participants
|
10 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Lmph (%), APBL, ref. range high, n=152, 143
|
14 Participants
|
18 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Lmph (%), APBL, ref. range low, n=152, 143
|
19 Participants
|
16 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Mono (%), BL, ref. range high, n=67, 54
|
13 Participants
|
11 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Mono (%), BL, ref. range low, n=67, 54
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Mono (%), APBL, ref. range high, n=137, 139
|
28 Participants
|
11 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Mono (%), APBL, ref. range low, n=137, 139
|
6 Participants
|
4 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
TNC (%), BL, ref. range high, n=68, 58
|
7 Participants
|
2 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
TNC (%), BL, ref. range low, n=68, 58
|
5 Participants
|
4 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
TNC (%), APBL, ref. range high, n=150, 145
|
9 Participants
|
10 Participants
|
|
Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
TNC (%), APBL, ref. range low, n=150, 145
|
19 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: At Baseline and every 6 weeks thereafter up to Month 12/Early Withdrawal VisitPopulation: Safety Population (primary analysis \[conducted in 2011\]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed. Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.
The clinical chemistry parameters assessed were: alanine amino transferase (ALT), albumin, alkaline phosphatase (ALP), aspartate amino transferase (AST), bicarbonate, blood urea nitrogen (BUN), bone alkaline phosphatase (Bone ALP), calcium, chloride, creatinine, creatinine clearance (Cr. Clearance), creatinine clearance estimated (Cr. Clrnc. est.), glucose, potassium, sodium, total bilirubin (Total Bln), total protein, urea, and uric acid. The Baseline (BL) value is the last available pre-treatment result recorded. "Any post-Baseline" value was based on results recorded at scheduled or unscheduled post-Baseline visits. The prevalence of values lying outside the reference (ref.) range (high or low) was presented for BL and "any post-Baseline" (APBL) visit. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=1573 Participants
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
n=1574 Participants
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
|---|---|---|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
ALT, BL, ref. range high, n=1569, 1569
|
55 Participants
|
78 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
ALT, BL, ref. range low, n=1569, 1569
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
ALT, APBL, ref. range high, n=1478, 1542
|
271 Participants
|
141 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
ALT, APBL, ref. range low, n=1478, 1542
|
3 Participants
|
5 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Albumin, BL, ref. range high, n=1568, 1568
|
36 Participants
|
41 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Albumin, BL, ref. range low, n=1568, 1568
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Albumin, APBL, ref. range high, n=1475, 1542
|
51 Participants
|
70 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Albumin, APBL, ref. range low, n=1475, 1542
|
11 Participants
|
8 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
ALP, BL, ref. range high, n=1569, 1569
|
68 Participants
|
66 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
ALP, BL, ref. range low, n=1569, 1569
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
ALP, APBL, ref. range high, n=1477, 1542
|
213 Participants
|
155 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
ALP, APBL, ref. range low, n=1477, 1542
|
4 Participants
|
5 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
AST, BL, ref. range high, n=1569, 1565
|
49 Participants
|
59 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
AST, BL, ref. range low, n=1569, 1565
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
AST, APBL, ref. range high, n=1478, 1541
|
260 Participants
|
139 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
AST, APBL, ref. range low, n=1478, 1541
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Bicarbonate, BL, ref. range high, n=36, 33
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Bicarbonate, BL, ref. range low, n=36, 33
|
4 Participants
|
3 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Bicarbonate, APBL, ref. range high, n=60, 71
|
3 Participants
|
2 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Bicarbonate, APBL, ref. range low, n=60, 71
|
4 Participants
|
9 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
BUN, BL, ref. range high, n=63, 56
|
8 Participants
|
4 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
BUN, BL, ref. range low, n=63, 56
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
BUN, APBL, ref. range high, n=161, 155
|
15 Participants
|
17 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
BUN, APBL, ref. range low, n=161, 155
|
6 Participants
|
4 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Bone ALP, BL, ref. range high, n=230, 219
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Bone ALP, BL, ref. range low, n=230, 219
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Bone ALP, APBL, ref. range high, n=188, 160
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Bone ALP, APBL, ref. range low, n=188, 160
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Calcium, BL, ref. range high, n=1568, 1565
|
17 Participants
|
36 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Calcium, BL, ref. range low, n=1568, 1565
|
16 Participants
|
14 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Calcium, APBL, ref. range high, n=1476, 1542
|
56 Participants
|
84 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Calcium, APBL, ref. range low, n=1476, 1542
|
66 Participants
|
79 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Chloride, BL, ref. range high, n=52, 46
|
2 Participants
|
2 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Chloride, BL, ref. range low, n=52, 46
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Chloride, APBL, ref. range high, n=102, 108
|
10 Participants
|
5 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Chloride, APBL, ref. range low, n=102, 108
|
2 Participants
|
5 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Creatinine, BL, ref. range high, n=1569, 1569
|
5 Participants
|
4 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Creatinine, BL, ref. range low, n=1569, 1569
|
7 Participants
|
8 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Creatinine, APBL, ref. range high, n=1479, 1542
|
16 Participants
|
13 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Creatinine, APBL, ref. range low, n=1479, 1542
|
22 Participants
|
27 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Cr. Clearance, BL, ref. range high, n=4, 9
|
2 Participants
|
2 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Cr. Clearance, BL, ref. range low, n=4, 9
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Cr. Clearance, APBL, ref. range high, n=11, 10
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Cr. Clearance, APBL, ref. range low, n=11, 10
|
2 Participants
|
2 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Cr. Clrnc. est., BL, ref. range high, n=373, 388
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Cr. Clrnc. est., BL, ref. range low, n=373, 388
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Cr. Clrnc. est., APBL, ref. range high, n=380, 418
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Cr. Clrnc. est., APBL, ref. range low, n=380, 418
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Glucose, BL, ref. range high, n=1566, 1569
|
170 Participants
|
143 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Glucose, BL, ref. range low, n=1566, 1569
|
31 Participants
|
32 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Glucose, APBL, ref. range high, n=1475, 1541
|
245 Participants
|
329 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Glucose, APBL, ref. range low, n=1475, 1541
|
94 Participants
|
94 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Potassium, BL, ref. range high, n=1567, 1565
|
13 Participants
|
13 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Potassium, BL, ref. range low, n=1567, 1565
|
21 Participants
|
11 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Potassium, APBL, ref. range high, n=1476, 1542
|
28 Participants
|
54 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Potassium, APBL, ref. range low, n=1476, 1542
|
54 Participants
|
44 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Sodium, BL, ref. range high, n=1568, 1568
|
9 Participants
|
4 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Sodium, BL, ref. range low, n=1568, 1568
|
7 Participants
|
9 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Sodium, APBL, ref. range high, n=1477, 1542
|
29 Participants
|
27 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Sodium, APBL, ref. range low, n=1477, 1542
|
24 Participants
|
30 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Total Bln., BL, ref. range high, n=1569, 1569
|
14 Participants
|
19 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Total Bln., BL, ref. range low, n=1569, 1569
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Total Bln., APBL, ref. range high, n=1478, 1542
|
152 Participants
|
46 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Total Bln., APBL, ref. range low, n=1478, 1542
|
4 Participants
|
3 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Total Protein, BL, ref. range high, n=1566, 1568
|
3 Participants
|
9 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Total Protein, BL, ref. range low, n=1566, 1568
|
4 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Total Protein, APBL, ref. range high, n=1476, 1542
|
27 Participants
|
38 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Total Protein, APBL, ref. range low, n=1476, 1542
|
11 Participants
|
13 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Urea, BL, ref. range high, n=1560, 1566
|
18 Participants
|
19 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Urea, BL, ref. range low, n=1560, 1566
|
17 Participants
|
24 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Urea, APBL, ref. range high, n=1465, 1535
|
35 Participants
|
48 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Urea, APBL, ref. range low, n=1465, 1535
|
45 Participants
|
48 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Uric acid, BL, ref. range high, n=37, 26
|
7 Participants
|
5 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Uric acid, BL, ref. range low, n=37, 26
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Uric acid, APBL, ref. range high, n=73, 76
|
10 Participants
|
12 Participants
|
|
Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Uric acid, APBL, ref. range low, n=73, 76
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study treatment up to 12 monthsPopulation: Safety Population. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported.
Non-laboratory toxicities are defined as adverse events (AEs). The number of partcipants with any treatment-emergent AE of the indicated toxicity grade are summarized. Toxicity grading was according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 as follows: Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life threatening; Grade 5=death. The events that were not given a toxicity grade are categorized as "Not Applicable."
Outcome measures
| Measure |
Lapatinib 1500 mg
n=1573 Participants
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
n=1574 Participants
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
|---|---|---|
|
Number of Participants With Non-laboratory Toxicities of the Indicated Toxicity Grades
Grade 1
|
414 Participants
|
558 Participants
|
|
Number of Participants With Non-laboratory Toxicities of the Indicated Toxicity Grades
Grade 2
|
674 Participants
|
505 Participants
|
|
Number of Participants With Non-laboratory Toxicities of the Indicated Toxicity Grades
Grade 3
|
333 Participants
|
104 Participants
|
|
Number of Participants With Non-laboratory Toxicities of the Indicated Toxicity Grades
Grade 4
|
21 Participants
|
15 Participants
|
|
Number of Participants With Non-laboratory Toxicities of the Indicated Toxicity Grades
Grade 5
|
3 Participants
|
3 Participants
|
|
Number of Participants With Non-laboratory Toxicities of the Indicated Toxicity Grades
Not Applicable
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From the date of randomization up to 12 monthsPopulation: Safety Population (SP). Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported.
A cardiac event is classified as a primary cardiac endpoint (PCE) or a secondary cardiac endpoint (SCE). PCE is defined as: cardiac death (cardiac death due to heart failure, myocardial infarction, or arrhythmia;or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event); severe symptomatic congestive heart failure (CHF) (as per New York Heart Association \[NYHA\] Class III or IV and an absolute decrease in left ventricular ejection fraction \[LVEF\] of more than 10 percentage points from Baseline and to a left ventricular ejection fraction \[LVEF\] value below 50%). SCE is defined as asymptomatic or mildly symptomatic cardiac events (NYHA Class I or II) and a significant decrease in LVEF, defined as an absolute decrease in LVEF of more than 10 percentage points from Baseline and to an LVEF value below 50%.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=1573 Participants
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
n=1574 Participants
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
|---|---|---|
|
Number of Participants Experiencing Primary or Secondary Cardiac Events
PCE, Cardiac death
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Primary or Secondary Cardiac Events
PCE, Severe symptomatic CHF
|
2 Participants
|
3 Participants
|
|
Number of Participants Experiencing Primary or Secondary Cardiac Events
SCE
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Screening and Month 12/Early Withdrawal VisitPopulation: SP. Only those participants (par.) available at the specified time points were analyzed. Two par. were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
12-lead ECG measurements were taken at Screening and at study conclusion/withdrawal. The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as classified by the investigator, were summarized. Participants with missing values were categorized as missing. Data for the primary analysis (conducted in 2011) are reported.
Outcome measures
| Measure |
Lapatinib 1500 mg
n=1543 Participants
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
n=1549 Participants
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
|---|---|---|
|
Number of Participants With the Indicated Electrocardiogram (ECG) Findings
Screening, normal, n=1543, 1549
|
1203 Participants
|
1197 Participants
|
|
Number of Participants With the Indicated Electrocardiogram (ECG) Findings
Screening, abnormal CS, n=1543, 1549
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Electrocardiogram (ECG) Findings
Screening, abnormal NCS, n=1543, 1549
|
339 Participants
|
351 Participants
|
|
Number of Participants With the Indicated Electrocardiogram (ECG) Findings
Screening, missing, n=1543, 1549
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Electrocardiogram (ECG) Findings
Conclusion/ Withdrawal, normal, n=1243, 1306
|
960 Participants
|
979 Participants
|
|
Number of Participants With the Indicated Electrocardiogram (ECG) Findings
Conclusion/ Withdrawal, abnormal CS, n=1243, 1306
|
5 Participants
|
3 Participants
|
|
Number of Participants With the Indicated Electrocardiogram (ECG) Findings
Conclusion/ Withdrawal, abnormal NCS, n=1243, 1306
|
276 Participants
|
323 Participants
|
|
Number of Participants With the Indicated Electrocardiogram (ECG) Findings
Conclusion/ Withdrawal, missing, n=1243, 1306
|
2 Participants
|
1 Participants
|
Adverse Events
Lapatinib 1500 mg
Serious events: 99 serious events
Other events: 1443 other events
Deaths: 0 deaths
Placebo
Serious events: 78 serious events
Other events: 1175 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lapatinib 1500 mg
n=1573 participants at risk
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
n=1574 participants at risk
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
|---|---|---|
|
Infections and infestations
Erysipelas
|
0.51%
8/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Cellulitis
|
0.32%
5/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Pneumonia
|
0.19%
3/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.13%
2/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Appendicitis
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Gastroenteritis
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Herpes zoster
|
0.13%
2/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Abscess
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Breast cellulitis
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Bronchopneumonia
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Cystitis
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Device related infection
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Gastroenteritis viral
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Implant site cellulitis
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Influenza
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Sepsis
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Sinusitis
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Streptococcal sepsis
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Urinary tract infection
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Wound infection
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.13%
2/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.13%
2/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.13%
2/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.13%
2/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Contralataral breast cancer
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac neoplasm unspecified
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papilloma of breast
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinaom metastatic
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyosarcoma
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.45%
7/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.19%
3/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Enteritis
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.13%
2/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.13%
2/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Vomiting
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.13%
2/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Haematochezia
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.19%
3/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.19%
3/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Cardiac disorders
Myocardial infarction
|
0.13%
2/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Cardiac disorders
Pericardial effusion
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Investigations
Ejection fraction decreased
|
0.32%
5/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.38%
6/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Investigations
Alanine aminotransferase increased
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Investigations
Blood bilirubin abnormal
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Investigations
Transaminases increased
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Injury, poisoning and procedural complications
Road tracffic accident
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.13%
2/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Nervous system disorders
Convulsion
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Nervous system disorders
Headache
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Nervous system disorders
Syncope
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.13%
2/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Hepatobiliary disorders
Cytolytic hepatitis
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Hepatobiliary disorders
Hepatitis
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.13%
2/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Reproductive system and breast disorders
Breast disorder
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Reproductive system and breast disorders
Breast mass
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Reproductive system and breast disorders
Ovarian enlargement
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
General disorders
Asthenia
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.13%
2/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
General disorders
Death
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Vascular disorders
Capillary leak syndrome
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Vascular disorders
Thrombosis
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Psychiatric disorders
Depression
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Psychiatric disorders
Suicide attempt
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Psychiatric disorders
Suicidal ideation
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.13%
2/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Immune system disorders
Drug hypersensitivity
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Immune system disorders
Hypersensitivity
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.13%
2/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Ear and labyrinth disorders
Vertigo
|
0.06%
1/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.00%
0/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Endocrine disorders
Thyroiditis subacute
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
Other adverse events
| Measure |
Lapatinib 1500 mg
n=1573 participants at risk
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
Placebo
n=1574 participants at risk
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
60.7%
955/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
16.3%
256/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
58.6%
922/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
15.4%
243/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Nausea
|
17.7%
279/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
11.4%
179/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
General disorders
Fatigue
|
16.0%
251/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
12.8%
202/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Nervous system disorders
Headache
|
8.9%
140/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
11.8%
185/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.0%
220/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
2.9%
45/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.4%
69/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
7.2%
113/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
130/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
3.1%
49/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
75/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
6.5%
103/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Vomiting
|
6.6%
104/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
4.5%
71/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
106/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
3.6%
57/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
105/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
3.6%
56/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.6%
135/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
1.6%
25/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Infections and infestations
Paronychia
|
9.8%
154/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.32%
5/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
8.3%
131/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
1.0%
16/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.3%
99/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
2.3%
36/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Eye disorders
Stomatitis
|
6.2%
98/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
1.9%
30/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.5%
118/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.51%
8/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
5.3%
83/1573 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
0.06%
1/1574 • Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
|
Additional Information
GSK Response Center
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Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER