Trial Outcomes & Findings for A Study in Cancer Patients to Evaluate the Effect of Lapatinib on the QTc Interval (NCT NCT01328054)
NCT ID: NCT01328054
Last Updated: 2016-06-08
Results Overview
A Holter monitor is an ambulatory portable device used for continuously monitoring the cardiovascular system. Three replicate electrocardiograms (ECGs) were collected at 30, 15, and 0 minutes prior to the administration of study treatment (trt) on Days 1 and 3 and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 2 and 4. The 3 readings at each time point (TP) were averaged prior to any analysis. BL is the average of the pre-dose QTcF values (triplicate) taken on Day 1 for PBO and on Day 3 for LAP. Mean change from BL was calculated by subtracting the BL values from individual QTcF for each TP. BL adjusted mean difference in absolute QTcF between LAB and PBO (trt difference) with the corresponding 90% confidence interval (CI) was estimated for each TP (pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, and 24-hr post-dose). Trt difference analysis was performed by a repeated measures analysis of variance adjusted for trt group, TP, and trt group\*TP interaction.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
58 participants
Primary outcome timeframe
Baseline (BL) (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours (hr) post-dose on Day 2 for placebo (PBO). Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib (LAP).
Results posted on
2016-06-08
Participant Flow
All participants (par.) underwent screening assessments within 14 days prior to the start of study treatment to determine their eligibility for enrollment. Study treatment was administered over a period of 5 days, and an End of Study visit was conducted on Day 8-11.
Participant milestones
| Measure |
Placebo
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
Participants received three doses of lapatinib 2000 milligrams (mg) (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Placebo on Day 1 and Day 2 (2 Days)
STARTED
|
57
|
0
|
|
Placebo on Day 1 and Day 2 (2 Days)
COMPLETED
|
57
|
0
|
|
Placebo on Day 1 and Day 2 (2 Days)
NOT COMPLETED
|
0
|
0
|
|
Lapatinib on Day 3 and Day 4 (2 Days)
STARTED
|
0
|
58
|
|
Lapatinib on Day 3 and Day 4 (2 Days)
COMPLETED
|
0
|
53
|
|
Lapatinib on Day 3 and Day 4 (2 Days)
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
Participants received three doses of lapatinib 2000 milligrams (mg) (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Lapatinib on Day 3 and Day 4 (2 Days)
Adverse Event
|
0
|
2
|
|
Lapatinib on Day 3 and Day 4 (2 Days)
Physician Decision
|
0
|
1
|
|
Lapatinib on Day 3 and Day 4 (2 Days)
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
A Study in Cancer Patients to Evaluate the Effect of Lapatinib on the QTc Interval
Baseline characteristics by cohort
| Measure |
Placebo and Lapatinib 2000 mg
n=58 Participants
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|
|
Age, Continuous
|
55.1 Years
STANDARD_DEVIATION 12.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
missing
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (BL) (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours (hr) post-dose on Day 2 for placebo (PBO). Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib (LAP).Population: Evaluable Population: all participants in the All-Treated Subjects (ATS) Population who met the criteria for dosing compliance, ECG acquisition, and Baseline ECG acquisition. The ATS Population is comprised of all participants who received at least one dose of study medication (placebo or lapatinib).
A Holter monitor is an ambulatory portable device used for continuously monitoring the cardiovascular system. Three replicate electrocardiograms (ECGs) were collected at 30, 15, and 0 minutes prior to the administration of study treatment (trt) on Days 1 and 3 and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 2 and 4. The 3 readings at each time point (TP) were averaged prior to any analysis. BL is the average of the pre-dose QTcF values (triplicate) taken on Day 1 for PBO and on Day 3 for LAP. Mean change from BL was calculated by subtracting the BL values from individual QTcF for each TP. BL adjusted mean difference in absolute QTcF between LAB and PBO (trt difference) with the corresponding 90% confidence interval (CI) was estimated for each TP (pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, and 24-hr post-dose). Trt difference analysis was performed by a repeated measures analysis of variance adjusted for trt group, TP, and trt group\*TP interaction.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
n=37 Participants
Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Treatment Difference in Duration of Cardiac Ventricular Depolarization and Repolarization Interval (QT) in Fridericia-corrected QT Interval (QTcF) Values Between Placebo and Lapatinib 2000mg
Pre-dose
|
-3.71 Milliseconds
Standard Error 1.53
|
2.60 Milliseconds
Standard Error 1.53
|
|
Treatment Difference in Duration of Cardiac Ventricular Depolarization and Repolarization Interval (QT) in Fridericia-corrected QT Interval (QTcF) Values Between Placebo and Lapatinib 2000mg
1 hour
|
0.66 Milliseconds
Standard Error 1.46
|
7.09 Milliseconds
Standard Error 1.47
|
|
Treatment Difference in Duration of Cardiac Ventricular Depolarization and Repolarization Interval (QT) in Fridericia-corrected QT Interval (QTcF) Values Between Placebo and Lapatinib 2000mg
2 hour
|
0.49 Milliseconds
Standard Error 1.23
|
8.20 Milliseconds
Standard Error 1.24
|
|
Treatment Difference in Duration of Cardiac Ventricular Depolarization and Repolarization Interval (QT) in Fridericia-corrected QT Interval (QTcF) Values Between Placebo and Lapatinib 2000mg
3 hour
|
2.78 Milliseconds
Standard Error 1.48
|
9.19 Milliseconds
Standard Error 1.48
|
|
Treatment Difference in Duration of Cardiac Ventricular Depolarization and Repolarization Interval (QT) in Fridericia-corrected QT Interval (QTcF) Values Between Placebo and Lapatinib 2000mg
4 hour
|
3.18 Milliseconds
Standard Error 1.73
|
9.78 Milliseconds
Standard Error 1.73
|
|
Treatment Difference in Duration of Cardiac Ventricular Depolarization and Repolarization Interval (QT) in Fridericia-corrected QT Interval (QTcF) Values Between Placebo and Lapatinib 2000mg
6 hour
|
-4.50 Milliseconds
Standard Error 1.82
|
1.36 Milliseconds
Standard Error 1.83
|
|
Treatment Difference in Duration of Cardiac Ventricular Depolarization and Repolarization Interval (QT) in Fridericia-corrected QT Interval (QTcF) Values Between Placebo and Lapatinib 2000mg
8 hour
|
-5.09 Milliseconds
Standard Error 1.93
|
-0.18 Milliseconds
Standard Error 1.95
|
|
Treatment Difference in Duration of Cardiac Ventricular Depolarization and Repolarization Interval (QT) in Fridericia-corrected QT Interval (QTcF) Values Between Placebo and Lapatinib 2000mg
10 hour
|
-4.53 Milliseconds
Standard Error 1.98
|
4.22 Milliseconds
Standard Error 1.99
|
|
Treatment Difference in Duration of Cardiac Ventricular Depolarization and Repolarization Interval (QT) in Fridericia-corrected QT Interval (QTcF) Values Between Placebo and Lapatinib 2000mg
12 hour
|
-1.49 Milliseconds
Standard Error 1.96
|
4.27 Milliseconds
Standard Error 1.96
|
|
Treatment Difference in Duration of Cardiac Ventricular Depolarization and Repolarization Interval (QT) in Fridericia-corrected QT Interval (QTcF) Values Between Placebo and Lapatinib 2000mg
24 hour
|
-1.25 Milliseconds
Standard Error 1.52
|
2.51 Milliseconds
Standard Error 1.55
|
SECONDARY outcome
Timeframe: Baseline (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 2 for placebo. Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib.Population: Evaluable Population. Only participants available at the specified time point (represented as n=X, X in the category title) were analyzed.
A Holter monitor is an ambulatory portable device for continuously monitoring the cardiovascular system. Change from Baseline in QT interval, QTc interval, QTcB interval, QTcI interval, RR interval, PR interval, and QRS duration at each time point for lapatinib was assessed in comparison with time-matched placebo. Three replicate ECGs were collected at 30, 15, and 0 minutes prior to the administration of study treatment on Days 1 and 3 and pre-dose and 1, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Days 2 and 4. The three readings at each time point were averaged prior to any analysis. Baseline is the average of the pre-dose ECGs (triplicate) taken on Day 1 for placebo and Day 3 for lapatinib. Change from Baseline was calculated by subtracting the Baseline values from individual post-Baseline values for each time point.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
n=37 Participants
Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QT interval (predose), n=37, 37
|
-6.24 Milliseconds
Standard Deviation 16.788
|
1.05 Milliseconds
Standard Deviation 17.033
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QT interval (1 hour), n=37, 37
|
0.10 Milliseconds
Standard Deviation 15.320
|
7.69 Milliseconds
Standard Deviation 18.870
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QT interval (2 hour), n=37, 37
|
1.24 Milliseconds
Standard Deviation 15.055
|
10.66 Milliseconds
Standard Deviation 16.315
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QT interval (3 hour), n=37, 37
|
2.14 Milliseconds
Standard Deviation 14.798
|
11.09 Milliseconds
Standard Deviation 18.805
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QT interval (4 hour), n=37, 37
|
1.14 Milliseconds
Standard Deviation 16.741
|
10.09 Milliseconds
Standard Deviation 20.062
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QT interval (6 hour), n=37, 36
|
-17.77 Milliseconds
Standard Deviation 21.240
|
-6.97 Milliseconds
Standard Deviation 20.888
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QT interval (8 hour), n=37, 36
|
-13.51 Milliseconds
Standard Deviation 20.997
|
-6.88 Milliseconds
Standard Deviation 25.718
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QT interval (10 hour), n=37, 37
|
-15.99 Milliseconds
Standard Deviation 19.617
|
-3.68 Milliseconds
Standard Deviation 21.191
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QT interval (12 hour), n=37, 37
|
-11.28 Milliseconds
Standard Deviation 18.576
|
-1.58 Milliseconds
Standard Deviation 21.615
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QT interval (24 hour), n=37, 35
|
-4.10 Milliseconds
Standard Deviation 15.152
|
0.54 Milliseconds
Standard Deviation 17.928
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcI interval (predose), n=37, 37
|
-6.40 Milliseconds
Standard Deviation 13.133
|
2.24 Milliseconds
Standard Deviation 12.930
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcI interval (1 hour), n=37, 37
|
-1.45 Milliseconds
Standard Deviation 10.925
|
6.00 Milliseconds
Standard Deviation 13.053
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcI interval (2 hour), n=37, 37
|
-1.40 Milliseconds
Standard Deviation 12.037
|
8.42 Milliseconds
Standard Deviation 13.054
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcI interval (3 hour), n=37, 37
|
-0.05 Milliseconds
Standard Deviation 12.015
|
8.76 Milliseconds
Standard Deviation 14.227
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcI interval (4 hour), n=37, 37
|
0.32 Milliseconds
Standard Deviation 13.786
|
8.00 Milliseconds
Standard Deviation 15.274
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcI interval (6 hour), n=37, 36
|
-11.53 Milliseconds
Standard Deviation 15.688
|
-3.86 Milliseconds
Standard Deviation 14.987
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcI interval (8 hour), n=37, 36
|
-10.13 Milliseconds
Standard Deviation 14.223
|
-4.65 Milliseconds
Standard Deviation 17.336
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcI interval (10 hour), n=37, 37
|
-11.70 Milliseconds
Standard Deviation 16.374
|
-0.26 Milliseconds
Standard Deviation 16.461
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcI interval (12 hour), n=37, 37
|
-6.22 Milliseconds
Standard Deviation 17.752
|
0.35 Milliseconds
Standard Deviation 15.458
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcI interval (24 hour), n=37, 35
|
-4.71 Milliseconds
Standard Deviation 9.677
|
2.03 Milliseconds
Standard Deviation 13.715
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcB interval (predose), n=37, 37
|
-2.18 Milliseconds
Standard Deviation 10.942
|
4.07 Milliseconds
Standard Deviation 9.271
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTc B interval (1 hour), n=37, 37
|
1.07 Milliseconds
Standard Deviation 8.061
|
7.37 Milliseconds
Standard Deviation 8.978
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcB interval (2 hour), n=37, 37
|
0.11 Milliseconds
Standard Deviation 8.918
|
7.43 Milliseconds
Standard Deviation 8.626
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcB interval (3 hour), n=37, 37
|
3.13 Milliseconds
Standard Deviation 8.954
|
8.77 Milliseconds
Standard Deviation 8.846
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcB interval (4 hour), n=37, 37
|
4.38 Milliseconds
Standard Deviation 10.786
|
10.14 Milliseconds
Standard Deviation 9.334
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcB interval (6 hour), n=37, 36
|
3.11 Milliseconds
Standard Deviation 10.275
|
7.08 Milliseconds
Standard Deviation 12.382
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcB interval (8 hour), n=37, 36
|
-0.29 Milliseconds
Standard Deviation 11.117
|
3.97 Milliseconds
Standard Deviation 10.481
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcB interval (10 hour), n=37, 37
|
1.93 Milliseconds
Standard Deviation 9.871
|
9.25 Milliseconds
Standard Deviation 13.060
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcB interval (12 hour), n=37, 37
|
4.21 Milliseconds
Standard Deviation 10.238
|
8.08 Milliseconds
Standard Deviation 11.379
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QTcB interval (24 hour), n=37, 35
|
0.42 Milliseconds
Standard Deviation 8.756
|
5.38 Milliseconds
Standard Deviation 7.752
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
RR interval (predose), n=37, 37
|
-19.19 Milliseconds
Standard Deviation 78.141
|
-9.68 Milliseconds
Standard Deviation 74.332
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
RR interval (1 hour), n=37, 37
|
-5.38 Milliseconds
Standard Deviation 65.333
|
3.14 Milliseconds
Standard Deviation 78.012
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
RR interval (2 hour), n=37, 37
|
2.71 Milliseconds
Standard Deviation 72.996
|
16.07 Milliseconds
Standard Deviation 63.665
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
RR interval (3 hour), n=37, 37
|
-5.38 Milliseconds
Standard Deviation 67.323
|
12.50 Milliseconds
Standard Deviation 67.526
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
RR interval (4 hour), n=37, 37
|
-13.43 Milliseconds
Standard Deviation 64.043
|
2.90 Milliseconds
Standard Deviation 78.299
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
RR interval (6 hour), n=37, 36
|
-85.20 Milliseconds
Standard Deviation 93.003
|
-61.77 Milliseconds
Standard Deviation 83.279
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
RR interval (8 hour), n=37, 36
|
-54.95 Milliseconds
Standard Deviation 92.426
|
-41.60 Milliseconds
Standard Deviation 90.545
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
RR interval (10 hour), n=37, 37
|
-74.17 Milliseconds
Standard Deviation 82.639
|
-49.38 Milliseconds
Standard Deviation 75.999
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
RR interval (12 hour), n=37, 37
|
-63.20 Milliseconds
Standard Deviation 79.552
|
-38.38 Milliseconds
Standard Deviation 74.737
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
RR interval (24 hour), n=37, 35
|
-19.69 Milliseconds
Standard Deviation 67.199
|
-17.15 Milliseconds
Standard Deviation 69.927
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
PR interval (predose), n=37, 37
|
-1.87 Milliseconds
Standard Deviation 9.162
|
3.48 Milliseconds
Standard Deviation 6.000
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
PR interval (1 hour), n=37, 37
|
-0.20 Milliseconds
Standard Deviation 7.026
|
4.90 Milliseconds
Standard Deviation 8.492
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
PR interval (2 hour), n=37, 37
|
0.90 Milliseconds
Standard Deviation 6.563
|
4.98 Milliseconds
Standard Deviation 8.952
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
PR interval (3 hour), n=37, 37
|
0.25 Milliseconds
Standard Deviation 7.839
|
4.86 Milliseconds
Standard Deviation 7.668
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
PR interval (4 hour), n=37, 37
|
-0.40 Milliseconds
Standard Deviation 7.321
|
4.05 Milliseconds
Standard Deviation 7.713
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
PR interval (6 hour), n=37, 36
|
-3.05 Milliseconds
Standard Deviation 9.165
|
0.32 Milliseconds
Standard Deviation 8.815
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
PR interval (8 hour), n=37, 36
|
-2.72 Milliseconds
Standard Deviation 6.993
|
0.10 Milliseconds
Standard Deviation 9.325
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
PR interval (10 hour), n=37, 37
|
-4.77 Milliseconds
Standard Deviation 6.892
|
-0.23 Milliseconds
Standard Deviation 8.743
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
PR interval (12 hour), n=37, 37
|
-2.97 Milliseconds
Standard Deviation 7.071
|
1.81 Milliseconds
Standard Deviation 9.503
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
PR interval (24 hour), n=37, 35
|
-1.61 Milliseconds
Standard Deviation 7.433
|
0.94 Milliseconds
Standard Deviation 6.388
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QRS interval (predose), n=37, 37
|
0.88 Milliseconds
Standard Deviation 3.562
|
0.46 Milliseconds
Standard Deviation 3.860
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QRS interval (1 hour), n=37, 37
|
1.45 Milliseconds
Standard Deviation 3.766
|
0.67 Milliseconds
Standard Deviation 4.164
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QRS interval (2 hour), n=37, 37
|
1.08 Milliseconds
Standard Deviation 3.290
|
0.66 Milliseconds
Standard Deviation 3.851
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QRS interval (3 hour), n=37, 37
|
0.89 Milliseconds
Standard Deviation 3.896
|
1.03 Milliseconds
Standard Deviation 4.786
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QRS interval (4 hour), n=37, 37
|
1.17 Milliseconds
Standard Deviation 3.612
|
1.83 Milliseconds
Standard Deviation 4.617
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QRS interval (6 hour), n=37, 36
|
0.88 Milliseconds
Standard Deviation 3.839
|
1.65 Milliseconds
Standard Deviation 4.212
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QRS interval (8 hour), n=37, 36
|
0.80 Milliseconds
Standard Deviation 3.500
|
1.47 Milliseconds
Standard Deviation 5.417
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QRS interval (10 hour), n=37, 37
|
0.70 Milliseconds
Standard Deviation 3.574
|
1.48 Milliseconds
Standard Deviation 5.042
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QRS interval (12 hour), n=37, 37
|
0.13 Milliseconds
Standard Deviation 3.634
|
1.92 Milliseconds
Standard Deviation 3.992
|
|
Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points
QRS interval (24 hour), n=37, 35
|
1.07 Milliseconds
Standard Deviation 3.890
|
0.97 Milliseconds
Standard Deviation 3.461
|
SECONDARY outcome
Timeframe: Baseline (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 2 for placebo. Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib.Population: Evaluable Population. Only participants available at the specified time point (represented as n=X, X in the category title) were analyzed.
The number of participants with 12-lead Holter ECG findings of normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) are reported. Abnormal ECG findings or change in ECG morphological patterns were based on the ECG interpretations provided by the ECG core lab. Three replicate 12-lead Holter ECGs were collected at -30, -15, and 0 minutes prior to the administration of study treatment on Days 1 (Baseline for placebo) and 3 (Baseline for lapatinib) and pre-dose and 1, 2, 3, 4, 6, 8, 10,12, and 24 hours post dose on Days 2 and 4. The three readings at each time point were averaged prior to any analysis. Baseline is the pre-dose ECGs (triplicate) taken on Day 1 for placebo and on Day 3 for lapatinib.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
n=37 Participants
Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
8 hour (NL), n=31, 27
|
31 Participants
|
27 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
-30 minutes (NL), n=35, 32
|
35 Participants
|
32 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
-30 minutes (Abn NCS), n=35, 32
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
-30 minutes (Abn CS), n=35, 32
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
-15 minutes (NL), n=34, 32
|
34 Participants
|
32 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
-15 minutes (Abn NCS), n=34, 32
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
-15 minutes (Abn CS), n=34, 32
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
0 minutes (NL), n=34, 32
|
34 Participants
|
32 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
0 minutes (Abn NCS), n=34, 32
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
0 minutes (Abn CS), n=34, 32
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
Pre dose (NL), n=33, 31
|
33 Participants
|
31 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
Pre dose (Abn NCS), n=33, 31
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
Pre dose (Abn CS), n=33, 31
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
1 hour (NL), n=33, 30
|
33 Participants
|
30 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
1 hour (Abn NCS), n=33, 30
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
1 hour (Abn CS), n=33, 30
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
2 hour (NL), n=31, 28
|
31 Participants
|
28 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
2 hour (Abn NCS), n=31, 28
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
2 hour (Abn CS), n=31, 28
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
3 hour (NL), n=31, 27
|
31 Participants
|
27 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
3 hour (Abn NCS), n=31, 27
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
3 hour (Abn CS), n=31, 27
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
4 hour (NL), n=34, 28
|
34 Participants
|
28 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
4 hour (Abn NCS), n=34, 28
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
4 hour (Abn CS), n=34, 28
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
6 hour (NL), n=31, 27
|
31 Participants
|
27 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
6 hour (Abn NCS), n=31, 27
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
6 hour (Abn CS), n=31, 27
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
8 hour (Abn NCS), n=31, 27
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
8 hour (Abn CS), n=31, 27
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
10 hour (NL), n=32, 31
|
32 Participants
|
31 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
10 hour (Abn NCS), n=32, 31
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
10 hour (Abn CS), n=32, 31
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
12 hour (NL), n=31, 29
|
31 Participants
|
29 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
12 hour (Abn NCS), n=31, 29
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
12 hour (Abn CS), n=31, 29
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
24 hour (NL), n=0, 27
|
0 Participants
|
27 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
24 hour (Abn NCS), n=0, 27
|
0 Participants
|
0 Participants
|
|
Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points
24 hour (Abn CS), n=0, 27
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 2 for placebo. Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib.Population: Pharmacodynamic (PD) Population: all participants from the All Treated Subjects Population (ATS) who completed the ECG acquisition via Holter monitoring of at least one time point on Days 1, 2, 3 and 4.
Abnormal ECG findings or change in ECG morphological patterns were based on the ECG interpretations provided by the ECG core lab. Three replicate Holter ECGs were collected at 30, 15, and 0 minutes prior to the administration of study treatment on Days 1 (Baseline for placebo) and 3 (Baseline for lapatinib) and pre-dose and 1, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Days 2 and 4. The three readings at each time point were averaged prior to any analysis. Baseline is the pre-dose ECGs (triplicate) taken on Day 1 for placebo and Day 3 for lapatinib. The number of participants with the worst-case post-Baseline 12-lead Holter ECG findings with significant ST, T wave, and U wave abnormalities were analyzed.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
n=52 Participants
Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Number of Participants With the Worst-case Post-Baseline 12-lead Holter ECG Findings With Significant ST, T Wave, and U Wave Abnormalities
|
11 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From the start of study treatment until follow-up (within approximately 28 days following the last dose of study medication [up to end of Study Week 4])Population: ATS Population
An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect, or is an important medical eventsthat jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, new primary cancers, liver events, cardiac dysfunction, pneumonitis, and laboratory abnormalities.
Outcome measures
| Measure |
Placebo
n=57 Participants
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
n=58 Participants
Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Any SAEs
|
0 Participants
|
4 Participants
|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Any AE
|
16 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: Baseline; Day 5 and end of study visit on Day 8-11Population: ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.
Blood samples were collected for the measurement of albumin and hemoglobin at Baseline; Days 5 and 8-11. Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.
Outcome measures
| Measure |
Placebo
n=58 Participants
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Mean Albumin, and Hemoglobin at the Indicated Time Points
Albumin (Baseline), n=58
|
38.8 Grams per liter (g/L)
Standard Deviation 3.83
|
—
|
|
Mean Albumin, and Hemoglobin at the Indicated Time Points
Albumin (Day 5), n=49
|
35.5 Grams per liter (g/L)
Standard Deviation 4.42
|
—
|
|
Mean Albumin, and Hemoglobin at the Indicated Time Points
Albumin (Day 8-11), n=55
|
37.5 Grams per liter (g/L)
Standard Deviation 3.94
|
—
|
|
Mean Albumin, and Hemoglobin at the Indicated Time Points
Hemoglobin (Baseline), n=58
|
123.7 Grams per liter (g/L)
Standard Deviation 15.45
|
—
|
|
Mean Albumin, and Hemoglobin at the Indicated Time Points
Hemoglobin (Day 5), n=48
|
114.8 Grams per liter (g/L)
Standard Deviation 15.63
|
—
|
|
Mean Albumin, and Hemoglobin at the Indicated Time Points
Hemoglobin (Day 8-11), n=55
|
117.6 Grams per liter (g/L)
Standard Deviation 15.51
|
—
|
SECONDARY outcome
Timeframe: Baseline; Day 5 and end of study visit on Day 8-11Population: ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.
Blood samples were collected for the measurement of ALP, ALT, and AST at Baseline; Days 5 and 8-11. Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.
Outcome measures
| Measure |
Placebo
n=58 Participants
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at the Indicated Time Points
ALP (baseline), n=58
|
116.9 International units per liter (IU/L)
Standard Deviation 90.91
|
—
|
|
Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at the Indicated Time Points
ALP (Day 5), n=49
|
111.2 International units per liter (IU/L)
Standard Deviation 97.55
|
—
|
|
Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at the Indicated Time Points
ALP (Day 8-11), n=55
|
116.7 International units per liter (IU/L)
Standard Deviation 107.50
|
—
|
|
Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at the Indicated Time Points
ALT (baseline), n=58
|
25.9 International units per liter (IU/L)
Standard Deviation 17.09
|
—
|
|
Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at the Indicated Time Points
ALT (Day 5), n=49
|
23.1 International units per liter (IU/L)
Standard Deviation 14.85
|
—
|
|
Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at the Indicated Time Points
ALT (Day 8-11), n=55
|
24.2 International units per liter (IU/L)
Standard Deviation 16.98
|
—
|
|
Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at the Indicated Time Points
AST (baseline), n=58
|
29.7 International units per liter (IU/L)
Standard Deviation 16.09
|
—
|
|
Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at the Indicated Time Points
AST (Day 5), n=48
|
26.9 International units per liter (IU/L)
Standard Deviation 14.16
|
—
|
|
Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at the Indicated Time Points
AST (Day 8-11), n=55
|
30.3 International units per liter (IU/L)
Standard Deviation 16.46
|
—
|
SECONDARY outcome
Timeframe: Baseline; Day 5 and end of study visit on Day 8-11Population: ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.
Blood samples were collected for the measurement of direct bilirubin, total bilirubin, and creatinine at Baseline; Days 5 and 8-11; Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.
Outcome measures
| Measure |
Placebo
n=58 Participants
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Mean Direct Bilirubin, Total Bilirubin, and Creatinine at the Indicated Time Points
Direct Bilirubin (Baseline), n=58
|
2.683 Micromoles per liter (µmol/L)
Standard Deviation 1.6678
|
—
|
|
Mean Direct Bilirubin, Total Bilirubin, and Creatinine at the Indicated Time Points
Direct Bilirubin (Day 5), n=46
|
3.123 Micromoles per liter (µmol/L)
Standard Deviation 2.0490
|
—
|
|
Mean Direct Bilirubin, Total Bilirubin, and Creatinine at the Indicated Time Points
Direct Bilirubin (Day 8-11), n=54
|
2.502 Micromoles per liter (µmol/L)
Standard Deviation 1.4749
|
—
|
|
Mean Direct Bilirubin, Total Bilirubin, and Creatinine at the Indicated Time Points
Bilirubin (Baseline), n=58
|
10.496 Micromoles per liter (µmol/L)
Standard Deviation 4.3620
|
—
|
|
Mean Direct Bilirubin, Total Bilirubin, and Creatinine at the Indicated Time Points
Bilirubin (Day 5), n=49
|
13.450 Micromoles per liter (µmol/L)
Standard Deviation 6.2571
|
—
|
|
Mean Direct Bilirubin, Total Bilirubin, and Creatinine at the Indicated Time Points
Bilirubin (Day 8-11), n=55
|
9.980 Micromoles per liter (µmol/L)
Standard Deviation 4.8786
|
—
|
|
Mean Direct Bilirubin, Total Bilirubin, and Creatinine at the Indicated Time Points
Creatinine (Baseline), n=58
|
73.448 Micromoles per liter (µmol/L)
Standard Deviation 23.6266
|
—
|
|
Mean Direct Bilirubin, Total Bilirubin, and Creatinine at the Indicated Time Points
Creatinine (Day 5), n=49
|
77.124 Micromoles per liter (µmol/L)
Standard Deviation 27.9006
|
—
|
|
Mean Direct Bilirubin, Total Bilirubin, and Creatinine at the Indicated Time Points
Creatinine (Day 8-11), n=55
|
74.192 Micromoles per liter (µmol/L)
Standard Deviation 25.0945
|
—
|
SECONDARY outcome
Timeframe: Baseline; Day 5 and end of study visit on Day 8-11Population: ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.
Blood samples were collected for the measurement of calcium, chloride, CO2, potassium, sodium, magnesium and urea at Baseline; at Days 5 and 8-11. Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.
Outcome measures
| Measure |
Placebo
n=58 Participants
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
Calcium (Baseline), n=57
|
2.344 Millimoles per liter (mmol/L)
Standard Deviation 0.1176
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
Calcium (Day 5), n=49
|
2.231 Millimoles per liter (mmol/L)
Standard Deviation 0.1148
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
Calcium (Day 8-11), n=55
|
2.303 Millimoles per liter (mmol/L)
Standard Deviation 0.1336
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
Chloride (Baseline), n=58
|
103.6 Millimoles per liter (mmol/L)
Standard Deviation 3.42
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
Chloride (Day 5), n=49
|
104.4 Millimoles per liter (mmol/L)
Standard Deviation 2.76
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
Chloride (Day 8-11), n=55
|
104.7 Millimoles per liter (mmol/L)
Standard Deviation 3.03
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
CO2 (Baseline), n=57
|
26.965 Millimoles per liter (mmol/L)
Standard Deviation 2.7449
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
CO2 (Day 5), n=49
|
26.053 Millimoles per liter (mmol/L)
Standard Deviation 3.1032
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
CO2 (Day 8-11), n=55
|
26.345 Millimoles per liter (mmol/L)
Standard Deviation 2.9390
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
Potassium (Baseline), n=58
|
4.05 Millimoles per liter (mmol/L)
Standard Deviation 0.337
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
Potassium (Day 5), n=49
|
3.84 Millimoles per liter (mmol/L)
Standard Deviation 0.425
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
Potassium (Day 8-11), n=55
|
3.98 Millimoles per liter (mmol/L)
Standard Deviation 0.372
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
Sodium (Baseline), n=58
|
138.8 Millimoles per liter (mmol/L)
Standard Deviation 2.42
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
Sodium (Day 5), n=49
|
138.5 Millimoles per liter (mmol/L)
Standard Deviation 2.34
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
Sodium (Day 8-11), n=55
|
139.0 Millimoles per liter (mmol/L)
Standard Deviation 2.55
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
Magnesium (Baseline), n=58
|
0.835 Millimoles per liter (mmol/L)
Standard Deviation 0.0906
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
Magnesium (Day 5, n=49)
|
0.769 Millimoles per liter (mmol/L)
Standard Deviation 0.1420
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
Magnesium (Day 8-11), n=55
|
0.795 Millimoles per liter (mmol/L)
Standard Deviation 0.1088
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
Urea (Baseline), n=58
|
5.273 Millimoles per liter (mmol/L)
Standard Deviation 1.9485
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
Urea (Day 5), n=49
|
5.078 Millimoles per liter (mmol/L)
Standard Deviation 1.7032
|
—
|
|
Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points
Urea (Day 8-11), n=55
|
5.095 Millimoles per liter (mmol/L)
Standard Deviation 1.7922
|
—
|
SECONDARY outcome
Timeframe: Baseline; Day 5 and end of study visit on Day 8-11Population: ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.
Blood samples were collected for the measurement of total neutrophils (ANC), platelets, and leukocyte count at Baseline; Days 5 and 8-11. Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.
Outcome measures
| Measure |
Placebo
n=58 Participants
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Mean Total Neutrophils (ANC [Absolute Neutrophil Count]), Platelets and Leukocyte Count at the Indicated Time Points
ANC (Baseline), n=58
|
23.959 10^9 cells per liter (GI/L)
Standard Deviation 30.0190
|
—
|
|
Mean Total Neutrophils (ANC [Absolute Neutrophil Count]), Platelets and Leukocyte Count at the Indicated Time Points
ANC (Day 5), n=48
|
25.802 10^9 cells per liter (GI/L)
Standard Deviation 30.8866
|
—
|
|
Mean Total Neutrophils (ANC [Absolute Neutrophil Count]), Platelets and Leukocyte Count at the Indicated Time Points
ANC (Day 8-11), n=55
|
23.848 10^9 cells per liter (GI/L)
Standard Deviation 29.8574
|
—
|
|
Mean Total Neutrophils (ANC [Absolute Neutrophil Count]), Platelets and Leukocyte Count at the Indicated Time Points
Platelets (Baseline), n=58
|
262.6 10^9 cells per liter (GI/L)
Standard Deviation 90.29
|
—
|
|
Mean Total Neutrophils (ANC [Absolute Neutrophil Count]), Platelets and Leukocyte Count at the Indicated Time Points
Platelets (Day 5), n=48
|
239.3 10^9 cells per liter (GI/L)
Standard Deviation 86.90
|
—
|
|
Mean Total Neutrophils (ANC [Absolute Neutrophil Count]), Platelets and Leukocyte Count at the Indicated Time Points
Platelets (Day 8-11), n=55
|
263.7 10^9 cells per liter (GI/L)
Standard Deviation 92.44
|
—
|
|
Mean Total Neutrophils (ANC [Absolute Neutrophil Count]), Platelets and Leukocyte Count at the Indicated Time Points
Leukocytes (Baseline), n=58
|
6.686 10^9 cells per liter (GI/L)
Standard Deviation 2.5192
|
—
|
|
Mean Total Neutrophils (ANC [Absolute Neutrophil Count]), Platelets and Leukocyte Count at the Indicated Time Points
Leukocytes (Day 5), n=48
|
6.227 10^9 cells per liter (GI/L)
Standard Deviation 2.3865
|
—
|
|
Mean Total Neutrophils (ANC [Absolute Neutrophil Count]), Platelets and Leukocyte Count at the Indicated Time Points
Leukocytes (Day 8-11), n=55
|
7.198 10^9 cells per liter (GI/L)
Standard Deviation 3.6319
|
—
|
SECONDARY outcome
Timeframe: Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post-dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post-dose)Population: ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.
Blood pressure measurements included SBP and DBP and were obtained at Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post dose). Baseline is defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Placebo
n=58 Participants
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Systolic BP (Day 2-Pre dose), n=58
|
-3.5 Millimeter of mercury (mmHg)
Standard Deviation 13.19
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Systolic BP (Day 2-4 hour post dose), n=58
|
-2.1 Millimeter of mercury (mmHg)
Standard Deviation 13.21
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Systolic BP (Day 2-8 hour post dose), n=58
|
-7.0 Millimeter of mercury (mmHg)
Standard Deviation 13.71
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Systolic BP (Day 2-12 hour post dose), n=58
|
-4.2 Millimeter of mercury (mmHg)
Standard Deviation 14.62
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Systolic BP (Day 2-24 hour post dose), n=58
|
-2.2 Millimeter of mercury (mmHg)
Standard Deviation 11.29
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Systolic BP (Day 4-Pre dose), n=56
|
-9.4 Millimeter of mercury (mmHg)
Standard Deviation 14.55
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Systolic BP (Day 4-4 hour post dose), n=55
|
-8.7 Millimeter of mercury (mmHg)
Standard Deviation 12.75
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Systolic BP (Day 4-8 hour post dose), n=55
|
-8.3 Millimeter of mercury (mmHg)
Standard Deviation 14.15
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Systolic BP (Day 4-12 hour post dose), n=54
|
-8.8 Millimeter of mercury (mmHg)
Standard Deviation 13.26
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Systolic BP (Day 4-24 hour post dose), n=54
|
-4.8 Millimeter of mercury (mmHg)
Standard Deviation 11.54
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Diastolic BP (Day 2-Pre dose), n=58
|
-4.2 Millimeter of mercury (mmHg)
Standard Deviation 8.34
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Diastolic BP (Day 2-4 hour post dose), n=58
|
-4.6 Millimeter of mercury (mmHg)
Standard Deviation 8.13
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Diastolic BP (Day 2-8 hour post dose), n=58
|
-8.2 Millimeter of mercury (mmHg)
Standard Deviation 9.13
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Diastolic BP (Day 2-12 hour post dose), n=58
|
-6.3 Millimeter of mercury (mmHg)
Standard Deviation 8.77
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Diastolic BP (Day 2-24 hour post dose), n=58
|
-2.9 Millimeter of mercury (mmHg)
Standard Deviation 7.27
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Diastolic BP (Day 4-Pre dose), n=56
|
-8.6 Millimeter of mercury (mmHg)
Standard Deviation 8.06
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Diastolic BP (Day 4-4 hour post dose), n=55
|
-7.3 Millimeter of mercury (mmHg)
Standard Deviation 8.49
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Diastolic BP (Day 4-8 hour post dose), n=55
|
-7.4 Millimeter of mercury (mmHg)
Standard Deviation 10.12
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Diastolic BP (Day 4-12 hour post dose), n=54
|
-8.1 Millimeter of mercury (mmHg)
Standard Deviation 9.29
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Diastolic BP (Day 4-24 hour post dose), n=54
|
-5.0 Millimeter of mercury (mmHg)
Standard Deviation 8.14
|
—
|
SECONDARY outcome
Timeframe: Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post dosePopulation: ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.
Heart rate were measured at Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post dose. Baseline is defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Placebo
n=58 Participants
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Day 2-Pre dose, n=57
|
3.9 Beats per minute
Standard Deviation 9.82
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Day 2-4 hour post dose, n=58
|
-1.7 Beats per minute
Standard Deviation 9.10
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Day 2-8 hour post dose, n=58
|
3.2 Beats per minute
Standard Deviation 9.96
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Day 2-12 hour post dose, n=58
|
3.3 Beats per minute
Standard Deviation 10.02
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Day 2-24 hour post dose, n=58
|
0.8 Beats per minute
Standard Deviation 9.78
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Day 4-Pre dose, n=56
|
3.5 Beats per minute
Standard Deviation 10.88
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Day 4-4 hour post dose, n=55
|
-2.0 Beats per minute
Standard Deviation 10.89
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Day 4-8 hour post dose, n=55
|
2.5 Beats per minute
Standard Deviation 11.12
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Day 4-12 hour post dose, n=54
|
3.2 Beats per minute
Standard Deviation 11.09
|
—
|
|
Change From Baseline in Heart Rate at the Indicated Time Points
Day 4-24 hour post dose, n=54
|
1.8 Beats per minute
Standard Deviation 8.75
|
—
|
SECONDARY outcome
Timeframe: BL;Day 1 (at pre-dose);Day 2 (at pre-dose, 4, 8, 12 and 24 hr post dose);Day 4 (at pre-dose, 4, 8, 12 and 24 hr post dose);End of Study visit (Day 8-11); and Follow-up (within approx 28 days following last dose of study trt [up to end of Study Week 4])Population: ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.
The number of participants with the 12-lead ECG findings normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) are reported. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee. A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at Baseline; on Day 1 (at pre-dose); on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post-last- dose); on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post-last-dose); at the End of Study visit (Day 8-11); and at the post-treatment Follow-up visit (if applicable).
Outcome measures
| Measure |
Placebo
n=58 Participants
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Baseline (Abn CS), n=58
|
0 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 8-11 (NL), n=50
|
29 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Baseline (NL), n=58
|
36 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Baseline (Abn NCS), n=58
|
22 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 1 (NL), n=58
|
35 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 1 (Abn NCS), n=58
|
23 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 1 (Abn CS), n=58
|
0 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 2 (Pre dose) (NL), n=58
|
32 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 2 (Pre dose) (Abn NCS), n=58
|
26 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 2 (Pre dose) (Abn CS), n=58
|
0 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 2 (4 hours post dose) (NL), n=58
|
34 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 2 (4 hours post dose) (Abn NCS), n=58
|
24 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 2 (4 hours post dose) (Abn CS), n=58
|
0 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 2 (8 hours post dose) (NL), n=58
|
30 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 2 (8 hours post dose) (Abn NCS), n=58
|
28 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 2 (8 hours post dose) (Abn CS), n=58
|
0 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 2 (12 hours post dose) (NL), n=58
|
31 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 2 (12 hours post dose) (Abn NCS), n=58
|
27 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 2 (12 hours post dose) (Abn CS), n=58
|
0 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 2 (24 hours post dose) (NL), n=58
|
34 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 2 (24 hours post dose) (Abn NCS), n=58
|
24 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 2 (24 hours post dose) (Abn CS), n=58
|
0 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 4 (Pre dose) (NL), n=56
|
31 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 4 (Pre dose) (Abn NCS), n=56
|
25 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 4 (Pre dose) (Abn CS), n=56
|
0 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 4 (4 hours post dose) (NL), n=55
|
26 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 4 (4 hours post dose) (Abn NCS), n=55
|
29 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 4 (4 hours post dose) (Abn CS), n=55
|
0 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 4 (8 hours post dose) (NL), n=55
|
25 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 4 (8 hours post dose) (Abn NCS), n=55
|
30 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 4 (8 hours post dose) (Abn CS), n=55
|
0 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 4 (12 hours post dose) (NL), n=55
|
27 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 4 (12 hours post dose) (Abn NCS), n=55
|
28 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 4 (12 hours post dose) (Abn CS), n=55
|
0 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 4 (24 hours post dose) (NL), n=54
|
28 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 4 (24 hours post dose) (Abn NCS), n=54
|
26 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 4 (24 hours post dose) (Abn CS), n=54
|
0 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 8-11 (Abn NCS), n=50
|
21 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Day 8-11 (Abn CS), n=50
|
0 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Follow-up (NL), n=2
|
1 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Follow-up (Abn NCS), n=2
|
1 Participants
|
—
|
|
Number of Participants With 12-lead ECG Findings at Indicated Time Points
Follow-up (Abn CS), n=2
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose; on Day 2 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-last-dose), and on Day 4 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-last-dose)Population: Pharmacokinetic (PK) Population: all participants in the ATS Population for whom at least one PK sample was obtained and analyzed. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.
AUC is defined as the area under the lapatinib concentration-time curve as a measure of drug exposure. AUC(0-t) and AUC(0-24) were determined from the plasma concentration-time data using the linear trapezoidal rule for increased concentrations and the logarithmic trapezoidal rule for decreased concentrations. For PK analysis, one blood sample was collected on Day 1 for placebo Baseline. The 24 hour blood sample on Day 2 also served for lapatinib Baseline. Pre-dose blood samples were collected 30 minutes prior to the administration of study medication on Day 2 (placebo) and Day 4 (lapatinib). Serial blood samples were collected on Day 2 (for placebo) and on Day 4 (for lapatinib) at the following post-last-dose time points 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Mean Area Under the Plasma Drug Concentration-time Curve (AUC) From Time Zero (Pre-dose) to the Last Time of Quantifiable Concentration (AUC[0-t]) and From Time Zero (Pre-dose) to 24 Hours Post Dose (AUC[0-24]) for Lapatinib
AUC[0-t]), n=56
|
56000 Nanograms hour per milliliter
Geometric Coefficient of Variation 73.4
|
—
|
|
Mean Area Under the Plasma Drug Concentration-time Curve (AUC) From Time Zero (Pre-dose) to the Last Time of Quantifiable Concentration (AUC[0-t]) and From Time Zero (Pre-dose) to 24 Hours Post Dose (AUC[0-24]) for Lapatinib
AUC[0-24]), n=54
|
59200 Nanograms hour per milliliter
Geometric Coefficient of Variation 60.2
|
—
|
SECONDARY outcome
Timeframe: Day1 pre-dose; on Day 2 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose), and on Day 4 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose)Population: PK Population
The first occurrence of Cmax and C24 was determined directly from the raw concentration-time data. For PK analysis, one blood sample was collected on Day 1 for placebo Baseline. The 24 hour blood sample on Day 2 also served for lapatinib Baseline. Pre-dose blood samples were collected 30 minutes prior to the administration of study medication on Day 2 (placebo) and Day 4 (lapatinib). Serial blood samples were collected on Day 2 (for placebo) and on Day 4 (for lapatinib) at the following post-last-dose time points 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Mean Maximum Plasma Concentration (Cmax) and Observed Plasma Concentration at 24 Hours Post-dose (C24) of Lapatinib
Cmax, n=56
|
3920 Nanograms per mL
Geometric Coefficient of Variation 50.8
|
—
|
|
Mean Maximum Plasma Concentration (Cmax) and Observed Plasma Concentration at 24 Hours Post-dose (C24) of Lapatinib
C24, n=54
|
1410 Nanograms per mL
Geometric Coefficient of Variation 88.1
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose; on Day 2 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose), and on Day 4 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose)Population: PK Population
For each participant, the time at which Cmax was observed (tmax) was determined directly from the raw concentration-time data. For each participant, the time prior to the first quantifiable (non-zero) concentration (tlag) was determined directly from the raw concentration-time data. Since all participants received 2 doses of study medication prior to the collection of the first (pre-dose) blood sample on Day 4, tlag was expected to be zero. For PK analysis, one blood sample was collected on Day 1 for placebo Baseline. The 24 hour blood sample on Day 2 also served for lapatinib Baseline. Pre-dose blood samples were collected 30 minutes prior to the administration of study medication on Day 2 (placebo) and Day 4 (lapatinib). Serial blood samples were collected on Day 2 (for placebo) and on Day 4 (for lapatinib) at the following post-last-dose time points 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Median Time to Cmax (Tmax) and the Time Prior to the First Quantifiable (Non-zero) Lapatinib Plasma Concentration (Tlag) Following the Last (3rd) Lapatinib Dose
tmax
|
3.55 Hours
Interval 0.0 to 24.1
|
—
|
|
Median Time to Cmax (Tmax) and the Time Prior to the First Quantifiable (Non-zero) Lapatinib Plasma Concentration (Tlag) Following the Last (3rd) Lapatinib Dose
tlag
|
0 Hours
Interval 0.0 to 0.0
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Lapatinib 2000 mg
Serious events: 4 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=57 participants at risk
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
n=58 participants at risk
Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
Other adverse events
| Measure |
Placebo
n=57 participants at risk
Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
|
Lapatinib 2000 mg
n=58 participants at risk
Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
15.5%
9/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Cardiac disorders
Conduction disorder
|
1.8%
1/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
0.00%
0/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
1/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
3.4%
2/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
3.4%
2/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
2/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
29.3%
17/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
5.2%
3/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Gastrointestinal disorders
Nausea
|
7.0%
4/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
8.6%
5/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Gastrointestinal disorders
Proctalgia
|
1.8%
1/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
5.2%
3/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
General disorders
Chest pain
|
1.8%
1/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
General disorders
Fatigue
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
10.3%
6/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
General disorders
Oedema peripheral
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
5.2%
3/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
3.4%
2/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Infections and infestations
Cellulitis
|
1.8%
1/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
0.00%
0/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Infections and infestations
Oral herpes
|
1.8%
1/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
0.00%
0/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.8%
1/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
0.00%
0/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
5.2%
3/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
3.4%
2/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
5.2%
3/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
5.2%
3/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
3.4%
2/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
6.9%
4/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
3.4%
2/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
1/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
3.4%
2/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Nervous system disorders
Dizziness
|
1.8%
1/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
3.4%
2/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Nervous system disorders
Headache
|
1.8%
1/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Nervous system disorders
Syncope
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
3.4%
2/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
5.2%
3/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
3.4%
2/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
5.2%
3/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
1.7%
1/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Vascular disorders
Hypertension
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
3.4%
2/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
|
Vascular disorders
Hypotension
|
0.00%
0/57 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
3.4%
2/58 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until the follow-up visit (up to 28 days after the last dose of lapatinib [up to end of Study Week 4]).
The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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