Study Of Adjuvant Lapatinib In High-Risk Head And Neck Cancer Subjects After Surgery

• ClinicalTrials.gov Identifier: NCT00424255
• Recruitment Status: Completed
• First Posted: January 19, 2007
• Results First Posted: February 11, 2014
• Last Update Posted: July 18, 2014
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Neoplasms, Head and Neck
• Interventions: Drug: Lapatinib; Radiation: Chemoradiation; Other: Placebo
• Enrollment: 688

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Period Title: Overall Study
Started	342	346
Completed	0	0
Not Completed	342	346
Reason Not Completed
Death	115	111
Lost to Follow-up	26	20
Protocol Violation	0	1
Withdrawal by Subject	34	38
Physician Decision	3	7
Cognitive Disturbance	1	0
Non-compliance by Participants	1	0
Fatigue	1	0
Disease Progression	0	2
Sponsor Terminated Study	161	167

Baseline Characteristics

Arm/Group Title		Placebo	Lapatinib 1500 mg	Total
Arm/Group Description		Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Total of all reporting groups
Overall Number of Baseline Participants		342	346	688
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	342 participants	346 participants	688 participants
		53.7 (9.85)	53.8 (8.38)	53.8 (9.14)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	342 participants	346 participants	688 participants
	Female	55 16.1%	60 17.3%	115 16.7%
	Male	287 83.9%	286 82.7%	573 83.3%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	342 participants	346 participants	688 participants
African American/African Heritage		1	0	1
Asian - Central/South Asian Heritage		61	53	114
Asian - East Asian Heritage		41	47	88
Asian - South East Asian Heritage		19	23	42
Asian - Mixed Race		0	1	1
White - Arabic/North African Heritage		1	3	4
White - White/Caucasian/European Heritage		219	219	438

Outcome Measures

1. Primary Outcome

Title	Disease Free Survival (DFS)
Description	DFS is defined as the time from randomization until the earliest date of disease recurrence (evidence of local, regional, or distant disease progression, second primary tumor) or death due to any cause. Disease recurrence was based on the assessments from the blinded, independent reviewer (radiological and clinical). Participants who initiated alternative anti-cancer therapy prior to disease recurrence or death were treated as censored at the last assessment prior to the time of this initiation. For participants whose disease did not recur or who did not die, DFS was censored at the time of the last independently assessed radiological scan (where initiation of alternative anti-cancer therapy had not commenced). Participants who missed two or more consecutive disease assessments were censored at the last assessment prior to the missed assessments. Participants considered to have malignant disease at Baseline were censored at the time of randomization.
Time Frame	From randomization until the earliest date of disease recurrence or death due to any cause (average of 101 study weeks)

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment, irrespective of whether they actually received study medication

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	342	346
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (54.6 to NA)	53.6 [2]; (45.8 to NA)

[1]

Because of an insufficient number of events, the median and the upper limit of the confidence interval were not reached.

[2]

Because of an insufficient number of events, the upper limit of the confidence interval was not reached.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lapatinib 1500 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2251
	Comments	The one-sided p-value is unstratified as there are too few events per stratum to perform a stratified test.
	Method	Non-stratified log-rank test
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lapatinib 1500 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4502
	Comments	The two-sided p-value is unstratified as there are too few events per stratum to perform a stratified test.
	Method	Non-stratified log-rank test
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Lapatinib 1500 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.43
	Estimation Comments	Hazard Ratios were estimated using a Pike estimator.

2. Secondary Outcome

Title	Overall Survival (OS)
Description	OS is defined as the time from randomization until death due to any cause. For participants who did not die, the time to death was censored at the time of last visit/contact.
Time Frame	From randomization until death due to any cause (average of 131 study weeks)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	342	346
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (NA to NA)	NA [2]; (58.8 to NA)

[1]

Because of an insufficient number of events, the median and the upper limit of the confidence interval were not reached.

[2]

Because of an insufficient number of events, the median and the confidence intervals were not reached.

3. Secondary Outcome

Title	Disease Specific Survival (DSS)
Description	DSS is defined as the time from randomization until death due to head and neck cancer. Participants whose death was not related to the disease under study were treated as competing risks at the time death occured. Participants who were alive were censored at the time of their last visit.
Time Frame	From randomization until death due to head and neck cancer (average of 131 study weeks)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	342	346
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (NA to NA)	NA [1]; (NA to NA)

[1]

Because of an insufficient number of events, the median and the confidence interval were not reached.

4. Secondary Outcome

Title	Time to Locoregional Recurrence (TTLR)
Description	TTLR is defined as the time from randomization until the first occurrence that local and/or regional recurrence is documented or the date of censor. Local relapse is defined as recurrent cancer in the primary tumor bed not clearly attributable to a second primary neoplasm. Regional relapse is defined as recurrent cancer in the neck not clearly attributable to a second primary neoplasm. All other events prior to locoregional recurrence were treated as competing risks at the time they occured. All other participants were treated as censored at the time of their last disease assessment. Participants with malignant disease at Baseline according to the independent review were censored at the time of randomization for the analysis of independently reviewed data.
Time Frame	From randomization until thefirst occurrence that local and/or regional recurrence is documented or the date of censor (average of 101 study weeks)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	342	346
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (NA to NA)	NA [2]; (NA to NA)

[1]

Because of an insufficient number of events, the median and confidence interval were not reached.

[2]

Because of an insufficient number of events, the median and the confidence interval were not reached.

5. Secondary Outcome

Title	Time to Distant Relapse (TTDR)
Description	TTDR is defined as the time from randomization until the first occurrence that distant relapse is documented. Distant relapse is defined as clear evidence of distant metastases (lung, bone, brain, etc.). Metastasis is defined as the spread of a cancer from one organ or part to another non-adjacent organ or part. All other events prior to a distant relapse were treated as competing risks at the time they occured. All other participants were treated as censored at the time of their last disease assessment. Participants with malignant disease at Baseline according to the independent review were censored at the time of randomization for the analysis of independently reviewed data.
Time Frame	From randomization until the first documented occurrence that distant relapse is documented (average of 101 study weeks)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	342	346
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (NA to NA)	NA [1]; (NA to NA)

[1]

Because of an insufficient number of events, the median and confidence interval were not reached.

6. Secondary Outcome

Title	Number of Participants With a Second Primary Tumor
Description	Participants who developed a second primary tumor at the time of the first recurrence or within 28 days of the first recurrence were measured. The criteria for a second primary tumor are as follows: a distinct lesion separated from the primary tumor site by >2 centimeters of normal epithelium; or a new cancer with different histology; or any cancer, regardless of site, occurring >=3 years after initial treatment. Participants with baseline disease were included in the denominator when calculating the percentage.
Time Frame	From randomization until development of second primary tumor or within 28 days of first recurrence (average of 101 study weeks)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	342	346
Measure Type: Number; Unit of Measure: Participants
	5	9

7. Secondary Outcome

Title	Extent of Exposure
Description	Extent of exposure is defined as the duration of treatment administered during the study. The mean duration of treatment is calculated as the number of days between the start of treatment and the end of treatment inclusive (i.e., treatment stop date minus treatment start date + 1). Participants were counted in a treatment phase (monotherapy, chemoradiotherapy, and maintenance) if they had received any dose in that phase. Participants randomized to placebo who received >=1 dose of lapatinib in error were included in the lapatinib arm.
Time Frame	From randomization until end of 1year maintenance treatment (average of 63 study weeks)

Outcome Measure Data

Analysis Population Description

Safety Population (SP): all participants (par.) who were randomized and took >=1 dose of study medication. Only par. available at the specified time points were analyzed (represented by n=X, X in the category titles). Different par. may have been analyzed for different parameters, so the overall number of par. analyzed reflects everyone in the SP.

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	336	349
Mean (Standard Deviation); Unit of Measure: Weeks
Monotherapy, n=332, 347	0.9 (0.32)	0.9 (0.27)
Chemoradiotherapy, n=327, 344	6.6 (1.29)	6.5 (1.58)
Maintenance, n=309, 321	41.5 (20.00)	41.1 (21.03)

8. Secondary Outcome

Title	Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Description	An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of non-serious AEs occurring at a frequency threshold of 5% and SAEs.
Time Frame	From the first dose of lapatinib/placebo until 5 days after the last dose (average of 141 study weeks)

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	336	349
Measure Type: Number; Unit of Measure: Participants
Any AE	328	344
Any SAE	133	169

9. Secondary Outcome

Title	Number of Participants With the Indicated Chemistry Toxicities by Maximum Toxicity Grade (G3 and G4) at the Worst-case On-therapy Visit
Description	Data are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI CTC version 3.0) toxicity grades. Data are reported as the number of participants who had a grade 3 (G3) or grade 4 (G4) toxicity for the indicated chemistry parameters, where G3 indicates a severe toxicity and G4 indicates a life-threatening toxicity. Clinical chemistry parameters included: albumin, alkaline phosphatase (AP), alanine amino transferase (ALT), aspartate amino transeferase (AST), total bilirubin (TB), calcium, carbon dioxide content/bicarbonate (CO2/HCO3), creatinine, glucose, potassium, and sodium. The worst-case on-therapy visit includes any scheduled or unscheduled post-Baseline visit.
Time Frame	From Baseline (within 8 weeks prior to randomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	336	349
Measure Type: Number; Unit of Measure: Participants
Albumin, Grade 3, n=330, 343	1	0
Albumin, Grade 4, n=330, 343	0	0
AP, Grade 3, n=333, 347	1	2
AP, Grade 4, n=333, 347	0	0
ALT, Grade 3, n=333, 348	9	3
ALT, Grade 4, n=333, 348	1	0
AST, Grade 3, n=333, 347	5	5
AST, Grade 4, n=333, 347	1	0
TB, Grade 3, n=333, 348	3	6
TB, Grade 4, n=333, 348	0	0
Hypercalcemia , Grade 3, n=333, 348	3	1
Hypercalcemia , Grade 4, n=333, 348	1	1
Hypocalcemia , Grade 3, n=333, 348	1	7
Hypocalcemia , Grade 4, n=333, 348	1	3
CO2/HCO3, Grade 3, n=187, 207	0	1
CO2/HCO3, Grade 4, n=187, 207	0	0
Creatinine, Grade 3, n=333, 348	3	9
Creatinine, Grade 4, n=333, 348	2	0
Hyperglycemia, Grade 3, n=332, 344	6	8
Hypergylcemia, Grade 4, n=332, 344	1	0
Hypoglycemia, Grade 3, n=332, 344	1	1
Hypogylcemia, Grade 4, n=332, 344	2	2
Hyperkalemia, Grade 3, n=333, 348	5	8
Hyperkalemia, Grade 4, n=333, 348	2	2
Hypokalemia, Grade 3, n=333, 348	17	35
Hypokalemia, Grade 4, n=333, 348	1	7
Hypernatremia, Grade 3, n=333, 348	0	0
Hypernatremia, Grade 4, n=333, 348	1	1
Hyponatremia, Grade 3, n=333, 348	59	85
Hyponatremia, Grade 4, n=333, 348	11	0

10. Secondary Outcome

Title	Number of Participants With the Indicated Hematological Toxicities by Maximum Toxicity Grade (G3 and G4) at the Worst-case On-therapy Visit
Description	Data are summarized using the NCI CTC version 3.0 toxicity grades. Data are reported as the number of participants who had a grade 3 (G3) or grade 4 (G4) toxicity for the indicated hematological parameters, where G3 indicates a severe toxicity and G4 indicates a life-threatening toxicity. The worst-case on-therapy visit includes any scheduled or unscheduled post-Baseline visit. Hematology parameter included: hemoglobin, total neutrophils (TN), platelet count (PC), and White Blood Cell (WBC) count.
Time Frame	From Baseline (within 8 weeks prior torandomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	336	349
Measure Type: Number; Unit of Measure: Participants
Hemoglobin, Grade 3, n=333, 348	10	13
Hemoglobin, Grade 4, n=333, 348	0	3
Lymphocytes, Grade 3, n=333, 348	203	208
Lymphocytes, Grade 4, n=333, 348	34	48
TN, Grade 3, n=333, 348	57	47
TN, Grade 4, n=333, 348	6	13
PC, Grade 3, n=333, 348	0	3
PC, Grade 4, n=333, 348	2	2
WBC, Grade 3, n=333, 348	70	72
WBC, Grade 4, n=333, 348	3	6

11. Secondary Outcome

Title	Number of Participants With On-therapy and Follow-up Late Radiation Morbidity Events
Description	Late radiation morbidity event data are summarized as the number of participants with late radiation morbidity events per system organ class (SOC). Late radiation effects are defined as those that first occur 90 days or more after the initiation of radiation therapy.
Time Frame	From 180 days after completion of radiation until the last follow-up/withdrawal visit (average of 64 study weeks)

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	336	349
Measure Type: Number; Unit of Measure: Participants
Gastrointestinal disorders	25	23
General disorders	8	13
Skin and subcutaneous tissue disorders	8	13
Musculoskeletal and connective tissue	13	6
Respiratory, thoracic and mediastinal	10	7
Injury, poisoning and procedural	13	3
Nervous system disorders	6	8
Endocrine disorders	4	3
Infections and infestations	3	4
Investigations	3	3
Vascular disorders	4	2
Blood and lymphatic system disorders	2	1
Ear and labyrinth disorders	2	1
Metabolism and nutrition disorders	0	1
Neoplasm benign, malignant and unspecified	1	0

12. Secondary Outcome

Title	Change From Baseline in Blood Pressure at the Indicated Time Points
Description	Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame	Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from investigational product (IP; up to Study Week 64)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	336	349
Mean (Standard Deviation); Unit of Measure: Millimeters of mercury (mmHg)
SBP, Week 1, n=312, 339	-0.29 (14.153)	1.24 (14.273)
SBP, Week 2, n=303, 327	-2.40 (13.815)	-1.56 (16.415)
SBP, Week 3, n=310, 319	-2.64 (14.784)	-1.62 (15.046)
SBP, Week 4, n=312, 319	-4.32 (15.414)	-2.63 (17.044)
SBP, Week 5, n=302, 303	-4.05 (15.490)	-3.09 (16.472)
SBP, Week 6, n=307, 307	-4.70 (15.571)	-4.07 (15.726)
SBP, Week 7, n=282, 289	-4.06 (14.774)	-4.86 (17.046)
SBP, End of CRT, n=304, 310	-4.79 (15.216)	-4.69 (16.692)
SBP, MW 8, n=280, 279	-2.80 (14.137)	-3.58 (15.030)
SBP, MW 16, n=257, 270	-2.86 (15.251)	-2.44 (15.718)
SBP, MW 24, n=234, 252	-3.44 (15.918)	-2.48 (15.793)
SBP, MW 32, n=212, 237	-1.71 (14.936)	-2.55 (15.470)
SBP, MW 40, n=202, 222	-1.76 (14.979)	-1.84 (17.358)
SBP, MW 48, n=199, 210	-1.57 (15.531)	-1.79 (15.700)
SBP, MW 56, n=188, 204	-1.53 (13.942)	-1.64 (15.878)
SBP, Withdrawal from IP, n=99, 84	-2.54 (15.746)	-1.38 (17.895)
DBP, Week 1, n=312, 339	-0.07 (9.214)	0.63 (9.719)
DBP, Week 2, n=303, 327	-0.81 (8.690)	-0.24 (9.933)
DBP, Week 3, n=310, 319	-0.46 (9.245)	-0.68 (9.704)
DBP, Week 4, n=312, 319	-2.54 (9.929)	-2.03 (9.797)
DBP, Week 5, n=302, 303	-1.38 (10.100)	-1.60 (9.679)
DBP, Week 6, n=307, 307	-1.85 (10.673)	-2.37 (9.514)
DBP, Week 7, n=282, 289	-1.73 (11.095)	-2.93 (9.402)
DBP, End of CRT, n=304, 310	-1.97 (10.224)	-2.11 (10.117)
DBP, MW 8, n=280, 279	-0.80 (9.598)	-1.17 (9.877)
DBP, MW 16, n=257, 270	-0.36 (9.980)	-0.98 (9.527)
DBP, MW 24, n=234, 252	-1.26 (9.956)	-1.65 (9.842)
DBP, MW 32, n=212, 237	-0.38 (9.677)	-1.34 (9.929)
DBP, MW 40, n=202, 222	-0.69 (9.809)	-0.69 (11.540)
DBP, MW 48, n=199, 210	0.34 (10.797)	-0.56 (10.057)
DBP, MW 56, n=188, 204	0.20 (9.721)	-0.47 (10.475)
DBP, Withdrawal from IP, n=99, 84	-0.27 (10.256)	-0.85 (11.806)

13. Secondary Outcome

Title	Change From Baseline in Heart Rate at the Indicated Time Points
Description	Heart rate (HR) was measured at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame	Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from IP (up to Study Week 64)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	336	349
Mean (Standard Deviation); Unit of Measure: Beats per minute
Week 1, n=312, 337	-0.18 (10.414)	-0.84 (10.710)
Week 2, n=303, 326	-0.99 (10.910)	-1.17 (10.258)
Week 3, n=306, 319	-0.45 (10.701)	-1.24 (9.766)
Week 4, n=307, 318	-0.86 (11.116)	-0.39 (11.645)
Week 5, n=298, 303	-0.68 (11.673)	-0.39 (11.588)
Week 6, n=306, 306	-0.73 (11.933)	-0.43 (10.947)
Week 7, n=279, 288	1.22 (11.491)	0.40 (11.184)
End of CRT, n=300, 310	0.33 (12.362)	0.54 (11.683)
MW 8, n=279, 277	-0.30 (10.684)	0.85 (10.632)
MW 16, n=256, 268	-1.10 (11.238)	-0.96 (11.129)
MW 24, n=235, 251	-0.98 (11.180)	-1.16 (9.793)
MW 32, n=213, 238	-1.43 (11.934)	-1.24 (10.549)
MW 40, n=203, 222	-2.72 (11.781)	-0.96 (10.556)
MW 48, n=200, 210	-2.56 (12.158)	-0.93 (11.659)
MW 56, n=189, 204	-3.08 (12.056)	-1.16 (11.331)
Withdrawal from IP, n=99, 83	0.02 (12.719)	-0.69 (11.822)

14. Secondary Outcome

Title	Change From Baseline in Body Temperature at the Indicated Time Points
Description	Body temperature was measured at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame	Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from IP (up to Study Week 64)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	336	349
Mean (Standard Deviation); Unit of Measure: Degrees Centigrade
Week 1, n=308, 331	-0.03 (0.420)	-0.01 (0.436)
Week 2, n=303, 321	-0.01 (0.492)	0.01 (0.410)
Week 3, n=308, 315	0.02 (0.504)	0.01 (0.431)
Week 4, n=306, 317	0.02 (0.511)	0.04 (0.494)
Week 5, n=300, 303	-0.00 (0.514)	0.03 (0.416)
Week 6, n=301, 302	0.06 (0.586)	0.02 (0.540)
Week 7, n=277, 288	0.02 (0.526)	0.06 (0.507)
End of CRT, n=297, 305	0.04 (0.545)	0.03 (0.469)
MW 8, n=274, 273	0.02 (0.529)	0.01 (0.442)
MW 16, n=253, 263	-0.02 (0.525)	-0.03 (0.400)
MW 24, n=227, 244	-0.03 (0.516)	0.04 (0.425)
MW 32, n=207, 235	-0.04 (0.559)	-0.02 (0.453)
MW 40, n=199, 219	-0.04 (0.542)	-0.00 (0.429)
MW 48, n=195, 205	-0.02 (0.645)	-0.01 (0.464)
MW 56, n=184, 200	-0.01 (0.563)	-0.02 (0.466)
Withdrawal from IP, n=97, 78	0.00 (0.562)	0.03 (0.419)

15. Secondary Outcome

Title	Change From Baseline in Body Weight at the Indicated Time Points
Description	Body weight was measured at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame	Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from IP (up to Study Week 64)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	336	349
Mean (Standard Deviation); Unit of Measure: Kilograms
Week 1, n=317, 343	0.28 (2.301)	-0.04 (2.263)
Week 2, n=314, 336	-0.39 (2.320)	-0.90 (2.747)
Week 3, n=319, 328	-1.01 (2.638)	-1.46 (2.889)
Week 4, n=316, 324	-1.74 (3.116)	-2.24 (3.352)
Week 5, n=307, 309	-2.46 (3.424)	-3.30 (3.803)
Week 6, n=314, 307	-3.22 (3.868)	-4.15 (3.912)
Week 7, n=290, 297	-4.21 (4.072)	-4.94 (4.266)
End of CRT, n=309, 311	-4.54 (4.566)	-5.36 (4.406)
MW 8, n=287, 287	-4.56 (5.851)	-5.67 (5.326)
MW 16, n=257, 275	-4.31 (6.521)	-5.64 (6.120)
MW 24, n=236, 252	-4.26 (7.251)	-5.15 (6.723)
MW 32, n=220, 241	-4.17 (7.685)	-4.73 (6.711)
MW 40, n=208, 224	-3.63 (7.889)	-4.24 (7.348)
MW 48, n=197, 212	-3.20 (7.951)	-3.44 (7.087)
MW 56, n=191, 206	-2.95 (8.427)	-3.47 (7.440)
Withdrawal from IP, n=106, 86	-4.21 (6.785)	-4.81 (7.649)

16. Secondary Outcome

Title	Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points
Description	A 12-lead ECG was recorded at Baseline, at the end of the CRT, at Maintenance Week 56, at withdrawal from IP, and at anytime post-baseline. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. The study investigator determined if an abnormal ECG finding was CS or NCS.
Time Frame	Baseline (BL; within 8 weeks prior to randomization [Day 1]), End of CRT, Maintenance Week 56, Withdrawal from IP, and at any time Post-Baseline (up to Study Week 64)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	336	349
Measure Type: Number; Unit of Measure: Participants
BL, Abnormal NCS, n=334, 349	82	78
BL, Abnormal CS, n=334, 349	1	0
End of CRT, Abnormal NCS, n=287, 292	76	71
End of CRT, Abnormal CS, n=287, 292	2	2
Maintenance Week 56, Abnormal NCS, n=166, 174	32	32
Maintenance Week 56, Abnormal CS, n=166, 174	2	0
Withdrawal from IP, Abnormal NCS, n=70, 59	16	12
Withdrawal from IP, Abnormal CS, n=70, 59	1	1
Anytime post-baseline, Abnormal NCS, n=307, 312	94	88
Anytime post-baseline, Abnormal CS, n=307, 312	4	3

17. Secondary Outcome

Title	Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value
Description	The Eastern Cooperative Oncology Group (ECOG) performance status scales and grades/criteria are used by doctors and researchers to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.
Time Frame	From Baseline (BL; within 8 weeks prior to randomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64)

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	336	349
Measure Type: Number; Unit of Measure: Participants
BL, ECOG 0, n=336, 349	173	179
BL, ECOG 1, n=336, 349	161	157
BL, ECOG 2, n=336, 349	2	13
Week 1, ECOG 0, n=319, 342	160	174
Week 1, ECOG 1, n=319, 342	156	159
Week 1, ECOG 2, n=319, 342	3	9
Week 1, ECOG 3, n=319, 342	0	0
Week 1, ECOG 4-5, n=319, 342	0	0
Week 2, ECOG 0, n=313, 333	142	149
Week 2, ECOG 1, n=313, 333	166	168
Week 2, ECOG 2, n=313, 333	5	16
Week 2, ECOG 3, n=313, 333	0	0
Week 2, ECOG 4-5, n=313, 333	0	0
Week 3, ECOG 0, n=310, 329	138	131
Week 3, ECOG 1, n=310, 329	169	183
Week 3, ECOG 2, n=310, 329	3	15
Week 3, ECOG 3, n=310, 329	0	0
Week 3, ECOG 4-5, n=310, 329	0	0
Week 4, ECOG 0, n=317, 327	115	111
Week 4, ECOG 1, n=317, 327	191	194
Week 4, ECOG 2, n=317, 327	11	21
Week 4, ECOG 3, n=317, 327	0	1
Week 4, ECOG 4-5, n=317, 327	0	0
Week 5, ECOG 0, n=307, 312	100	95
Week 5, ECOG 1, n=307, 312	191	183
Week 5, ECOG 2, n=307, 312	16	30
Week 5, ECOG 3, n=307, 312	0	4
Week 5, ECOG 4-5, n=307, 312	0	0
Week 6, ECOG 0, n=312, 309	97	88
Week 6, ECOG 1, n=312, 309	187	186
Week 6, ECOG 2, n=312, 309	26	32
Week 6, ECOG 3, n=312, 309	2	3
Week 6, ECOG 4-5, n=312, 309	0	0
Week 7, ECOG 0, n=284, 295	83	88
Week 7, ECOG 1, n=284, 295	175	176
Week 7, ECOG 2, n=284, 295	23	30
Week 7, ECOG 3, n=284, 295	3	1
Week 7, ECOG 4-5, n=284, 295	0	0
End of CRT, ECOG 0, n=307, 315	95	84
End of CRT, ECOG 1, n=307, 315	184	186
End of CRT, ECOG 2, n=307, 315	25	45
End of CRT, ECOG 3, n=307, 315	3	0
End of CRT, ECOG 4-5, n=307, 315	0	0
Maintenance week 8, ECOG 0, n=286, 290	132	128
Maintenance week 8, ECOG 1, n=286, 290	146	153
Maintenance week 8, ECOG 2, n=286, 290	7	9
Maintenance week 8, ECOG 3, n=286, 290	1	0
Maintenance week 8, ECOG 4-5, n=286, 290	0	0
Maintenance week 16, ECOG 0, n=260, 273	135	129
Maintenance week 16, ECOG 1, n=260, 273	124	138
Maintenance week 16, ECOG 2, n=260, 273	1	6
Maintenance week 16, ECOG 3, n=260, 273	0	0
Maintenance week 16, ECOG 4-5, n=260, 273	0	0
Maintenance week 24, ECOG 0, n=235, 251	122	127
Maintenance week 24, ECOG 1, n=235, 251	110	119
Maintenance week 24, ECOG 2, n=235, 251	3	5
Maintenance week 24, ECOG 3, n=235, 251	0	0
Maintenance week 24, ECOG 4-5, n=235, 251	0	0
Maintenance week 32, ECOG 0, n=218, 241	117	123
Maintenance week 32, ECOG 1, n=218, 241	99	115
Maintenance week 32, ECOG 2, n=218, 241	2	1
Maintenance week 32, ECOG 3, n=218, 241	0	2
Maintenance week 32, ECOG 4-5, n=218, 241	0	0
Maintenance week 40, ECOG 0, n=208, 227	118	130
Maintenance week 40, ECOG 1, n=208, 227	88	94
Maintenance week 40, ECOG 2, n=208, 227	2	2
Maintenance week 40, ECOG 3, n=208, 227	0	1
Maintenance week 40, ECOG 4-5, n=208, 227	0	0
Maintenance week 48, ECOG 0, n=205, 214	121	111
Maintenance week 48, ECOG 1, n=205, 214	81	102
Maintenance week 48, ECOG 2, n=205, 214	3	1
Maintenance week 48, ECOG 3, n=205, 214	0	0
Maintenance week 48, ECOG 4-5, n=205, 214	0	0
Maintenance week 56, ECOG 0, n=194, 211	107	111
Maintenance week 56, ECOG 1, n=194, 211	85	98
Maintenance week 56, ECOG 2, n=194, 211	2	2
Maintenance week 56, ECOG 3, n=194, 211	0	0
Maintenance week 56, ECOG 4-5, n=194, 211	0	0
Withdrawal from IP, ECOG 0, n=109, 92	44	38
Withdrawal from IP, ECOG 1, n=109, 92	50	40
Withdrawal from IP, ECOG 2, n=109, 92	12	11
Withdrawal from IP, ECOG 3, n=109, 92	2	1
Withdrawal from IP, ECOG 4-5, n=109, 92	1	2
Last assessment on therapy, ECOG 0, n=334, 348	153	154
Last assessment on therapy, ECOG 1, n=334, 348	158	165
Last assessment on therapy, ECOG 2, n=334, 348	19	22
Last assessment on therapy, ECOG 3, n=334, 348	3	5
Last assessment on therapy, ECOG 4-5, n=334, 348	1	2

18. Secondary Outcome

Title	Change From Baseline in Quality of Life Status as Assessed by the Functional Assessement of Cancer Therapy-Head and Neck (FACT-H&N) Questionnaire
Description	Change from Baseline in quality of life status was assessed using the FACT-H&N questionnaire, which is designed to measure multidimensional quality of life in participants with head and neck cancer. Change from Baseline was analyzed using parametric analysis of covariance (with the Baseline value as a covariate). The FACT-H&N questionnaire contains 39 items (27 general questions and 12 head and neck cancer-specific items) covering 4 dimensions and 1 subscale: physical well-being, social/family well-being, emotional well-being, functional well-being, and a head and neck cancer subscale. Possible subscale scores range from 0 to 36. Higher scores represent better quality of life. Data were adjusted for participant-reported quality of life scores at Baseline.
Time Frame	From randomization until the last follow-up/withdrawal visit (up to 62 study weeks)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants who had a Baseline and post-Baseline score at the specified time points were analyzed.

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	171	189
Least Squares Mean (Standard Error); Unit of Measure: scores on a scale
Physical Well-being, n=171, 188	0.4 (0.33)	-0.1 (0.31)
Social/Family Well-being, n=171, 189	-0.3 (0.36)	-1.7 (0.34)
Emotional Well-being, n=169, 187	1.0 (0.27)	0.0 (0.26)
Functional Well-being, n=168, 188	0.9 (0.39)	-0.4 (0.37)
Head and Neck Cancer subscale, n=168, 189	-1.2 (0.43)	-1.7 (0.40)

19. Secondary Outcome

Title	Change From Baseline in Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale
Description	Change from Baseline in quality of life status was assessed using the EQ-5D scale, a 5-item health status measure and a visual analog rating scale. Change from Baseline was analyzed using parametric analysis of covariance (with the Baseline value as a covariate). The EQ-5D is a generic measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. The EQ-5D covers health status in 5 domains (3 questions each): mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each item is scored as follows: 1, no problems; 2, some moderate problems; 3, extreme problems. The possible EQ-5D index utility values range from 0.594 to 1, and the thermometer score ranges from 0 to 100. Higher scores represent better quality of life. Data were adjusted for participant-reported quality of life scores at Baseline.
Time Frame	From randomization until the last follow-up/withdrawal visit (up to 62 study weeks)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants who had a Baseline and post-Baseline score at the specified time points were analyzed.

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	173	187
Least Squares Mean (Standard Error); Unit of Measure: scores on a scale
Utility score, n=172, 186	0.1 (0.01)	0.0 (0.01)
Thermometer score, n=173, 197	5.5 (1.29)	3.2 (1.25)

20. Secondary Outcome

Title	Number of Participants With the Indicated Biomarker Expression Status
Description	Biomarkers (which influence clinical response) assessed from tumor tissues included P16, Human Papilloma virus (HPV), and Epidermal Growth Factor Receptor (EGFR)/Epidermal Growth Factor Receptor 1 (ErbB1). Biomarker expression is presented as positive, negative, or unknown. Participants in the ErbB1-positive category include those with results of positive or strongly positive.
Time Frame	Baseline (BL; within 8 weeks prior to randomization [Day 1]) (up to Study Week 1)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	342	346
Measure Type: Number; Unit of Measure: Participants
P16, Positive	42	48
P16, Negative	282	271
P16, Unknown	18	27
Overall HPV, Positive	21	23
Overall HPV, Negative	284	276
Overall HPV, Unknown	37	47
ErbB1, Positive	330	338
ErbB1, Negative	12	8

21. Secondary Outcome

Title	Number of Participants With the Indicated Worst-case On-therapy Left Ventricular Ejection Fraction (LVEF) Change From Baseline
Description	LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart with each contraction. LVEF was assessed using echocardiogram (ECHO: a test of the action of the heart using ultrasound waves to produce a visual display, for the diagnosis or monitoring of heart disease ) and multigated acqusition scans (MUGA scan: a noninvasive diagnostic test used to evaluate the pumping function of the ventricles). Data from the ECHO and MUGA scans were combined, and the absolute change from Baseline (Abs) data are presented according to the following categories: No change or any increase, 0-<10% decrease, 10-19% decrease, >=20% decrease, >=10% decrease and >=the Lower Limit of Normal (LLN), >=10% decrease and below LLN, >=20% decrease and >=LLN, or >=20% decrease and below LLN. The relative percent change from Baseline (Rel) data are presented according to the following categories: >=20% decrease and >=LLN and >=20% decrease and below LLN.
Time Frame	From the end of the CRT until the last follow-up visit (average of 141 study weeks)

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants available at the specified time points were analyzed.

Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description:	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
Overall Number of Participants Analyzed	309	311
Measure Type: Number; Unit of Measure: Participants
Abs, No change/any increase	102	90
Abs, >0 to <10% decrease	138	131
Abs, 10 to 19% decrease	65	80
Abs, >=20% decrease	4	10
Abs, >=10% decrease and >=LLN	62	69
Abs, >=10% decrease and below LLN	7	21
Abs, >=20% decrease and >=LLN	3	5
Abs, >=20% decrease and below LLN	1	5
Rel, >=20% decrease and >=LLN	22	18
Rel, >=20% decrease and below LLN	3	14

Adverse Events

Time Frame	Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow up of treatment (average of 141 study weeks).
Adverse Event Reporting Description	SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants who were randomized and took at least one dose of study medication. Participants randomized to placebo who received >=1 dose of lapatinib in error were included in the lapatinib arm.
Arm/Group Title	Placebo	Lapatinib 1500 mg
Arm/Group Description	Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.	Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
All-Cause Mortality
	Placebo	Lapatinib 1500 mg
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Placebo	Lapatinib 1500 mg
	Affected / at Risk (%)	Affected / at Risk (%)
Total	133/336 (39.58%)	169/349 (48.42%)
Blood and lymphatic system disorders
Lymphopenia † 1	17/336 (5.06%)	18/349 (5.16%)
Neutropenia † 1	10/336 (2.98%)	10/349 (2.87%)
Anaemia † 1	2/336 (0.60%)	7/349 (2.01%)
Febrile neutropenia † 1	4/336 (1.19%)	5/349 (1.43%)
Leukopenia † 1	5/336 (1.49%)	4/349 (1.15%)
Thrombocytopenia † 1	3/336 (0.89%)	2/349 (0.57%)
Bone marrow failure † 1	0/336 (0.00%)	1/349 (0.29%)
Disseminated intravascular coagulation † 1	1/336 (0.30%)	0/349 (0.00%)
Haematotoxicity † 1	0/336 (0.00%)	1/349 (0.29%)
Cardiac disorders
Cardiac arrest † 1	2/336 (0.60%)	1/349 (0.29%)
Left ventricular dysfunction † 1	0/336 (0.00%)	2/349 (0.57%)
Acute myocardial infarction † 1	0/336 (0.00%)	1/349 (0.29%)
Atrial fibrillation † 1	1/336 (0.30%)	0/349 (0.00%)
Cardiac failure acute † 1	0/336 (0.00%)	1/349 (0.29%)
Cardio-respiratory arrest † 1	1/336 (0.30%)	0/349 (0.00%)
Diastolic dysfunction † 1	0/336 (0.00%)	1/349 (0.29%)
Intracardiac mass † 1	0/336 (0.00%)	1/349 (0.29%)
Palpitations † 1	0/336 (0.00%)	1/349 (0.29%)
Ventricular hypokinesia † 1	1/336 (0.30%)	0/349 (0.00%)
Cardiopulmonary failure † 1	0/336 (0.00%)	1/349 (0.29%)
Congenital, familial and genetic disorders
Aplasia † 1	0/336 (0.00%)	1/349 (0.29%)
Ear and labyrinth disorders
Hypoacusis † 1	1/336 (0.30%)	0/349 (0.00%)
Neurosensory hypoacusis † 1	0/336 (0.00%)	1/349 (0.29%)
Endocrine disorders
Hypothyroidism † 1	1/336 (0.30%)	0/349 (0.00%)
Eye disorders
Conjunctival haemorrhage † 1	0/336 (0.00%)	1/349 (0.29%)
Periorbital oedema † 1	0/336 (0.00%)	1/349 (0.29%)
Gastrointestinal disorders
Vomiting † 1	8/336 (2.38%)	12/349 (3.44%)
Dysphagia † 1	5/336 (1.49%)	11/349 (3.15%)
Nausea † 1	3/336 (0.89%)	7/349 (2.01%)
Diarrhoea † 1	3/336 (0.89%)	6/349 (1.72%)
Stomatitis † 1	5/336 (1.49%)	4/349 (1.15%)
Oesophageal stenosis † 1	1/336 (0.30%)	3/349 (0.86%)
Mouth haemorrhage † 1	1/336 (0.30%)	2/349 (0.57%)
Oral pain † 1	1/336 (0.30%)	1/349 (0.29%)
Anal fistula † 1	0/336 (0.00%)	1/349 (0.29%)
Constipation † 1	1/336 (0.30%)	0/349 (0.00%)
Dyspepsia † 1	0/336 (0.00%)	1/349 (0.29%)
Gastric perforation † 1	0/336 (0.00%)	1/349 (0.29%)
Gastrooesophagitis † 1	0/336 (0.00%)	1/349 (0.29%)
Haematemesis † 1	0/336 (0.00%)	1/349 (0.29%)
Oesophageal fistula † 1	1/336 (0.30%)	0/349 (0.00%)
Oesophagitis ulcerative † 1	0/336 (0.00%)	1/349 (0.29%)
Pancreatitis † 1	0/336 (0.00%)	1/349 (0.29%)
Pancreatitis acute † 1	1/336 (0.30%)	0/349 (0.00%)
Retroperitoneal haemorrhage † 1	1/336 (0.30%)	0/349 (0.00%)
Stomatitis haemorrhagic † 1	0/336 (0.00%)	1/349 (0.29%)
General disorders
Mucosal inflammation † 1	9/336 (2.68%)	17/349 (4.87%)
Pyrexia † 1	5/336 (1.49%)	6/349 (1.72%)
General physical health deterioration † 1	6/336 (1.79%)	4/349 (1.15%)
Asthenia † 1	3/336 (0.89%)	4/349 (1.15%)
Death † 1	1/336 (0.30%)	4/349 (1.15%)
Fatigue † 1	2/336 (0.60%)	2/349 (0.57%)
Impaired healing † 1	1/336 (0.30%)	1/349 (0.29%)
Malaise † 1	2/336 (0.60%)	0/349 (0.00%)
Medical device complication † 1	1/336 (0.30%)	1/349 (0.29%)
Catheter site discharge † 1	1/336 (0.30%)	0/349 (0.00%)
Catheter site related reaction † 1	0/336 (0.00%)	1/349 (0.29%)
Disease progression † 1	0/336 (0.00%)	1/349 (0.29%)
Face oedema † 1	0/336 (0.00%)	1/349 (0.29%)
Mucosal induration † 1	0/336 (0.00%)	1/349 (0.29%)
Non-cardiac chest pain † 1	0/336 (0.00%)	1/349 (0.29%)
Performance status decreased † 1	1/336 (0.30%)	0/349 (0.00%)
Sudden death † 1	0/336 (0.00%)	1/349 (0.29%)
Hepatobiliary disorders
Hyperbilirubinaemia † 1	1/336 (0.30%)	2/349 (0.57%)
Infections and infestations
Pneumonia † 1	4/336 (1.19%)	6/349 (1.72%)
Sepsis † 1	2/336 (0.60%)	4/349 (1.15%)
Wound infection † 1	0/336 (0.00%)	3/349 (0.86%)
Bronchopneumonia † 1	1/336 (0.30%)	1/349 (0.29%)
Erysipelas † 1	2/336 (0.60%)	0/349 (0.00%)
Gastroenteritis † 1	1/336 (0.30%)	1/349 (0.29%)
Lung abscess † 1	0/336 (0.00%)	2/349 (0.57%)
Lung infection † 1	1/336 (0.30%)	1/349 (0.29%)
Neutropenic sepsis † 1	1/336 (0.30%)	1/349 (0.29%)
Oral infection † 1	0/336 (0.00%)	2/349 (0.57%)
Abscess limb † 1	0/336 (0.00%)	1/349 (0.29%)
Abscess neck † 1	1/336 (0.30%)	0/349 (0.00%)
Bacteraemia † 1	0/336 (0.00%)	1/349 (0.29%)
Blister infected † 1	1/336 (0.30%)	0/349 (0.00%)
Catheter site infection † 1	0/336 (0.00%)	1/349 (0.29%)
Cellulitis † 1	1/336 (0.30%)	0/349 (0.00%)
Febrile infection † 1	0/336 (0.00%)	1/349 (0.29%)
Lobar pneumonia † 1	1/336 (0.30%)	0/349 (0.00%)
Lower respiratory tract infection † 1	1/336 (0.30%)	0/349 (0.00%)
Osteomyelitis † 1	1/336 (0.30%)	0/349 (0.00%)
Otitis media † 1	1/336 (0.30%)	0/349 (0.00%)
Paraoesophageal abscess † 1	0/336 (0.00%)	1/349 (0.29%)
Parotid abscess † 1	1/336 (0.30%)	0/349 (0.00%)
Perichondritis † 1	1/336 (0.30%)	0/349 (0.00%)
Pulmonary tuberculosis † 1	0/336 (0.00%)	1/349 (0.29%)
Pyelonephritis † 1	0/336 (0.00%)	1/349 (0.29%)
Respiratory tract infection † 1	0/336 (0.00%)	1/349 (0.29%)
Sepsis syndrome † 1	1/336 (0.30%)	0/349 (0.00%)
Septic shock † 1	1/336 (0.30%)	0/349 (0.00%)
Streptococcal sepsis † 1	1/336 (0.30%)	0/349 (0.00%)
Superinfection † 1	1/336 (0.30%)	0/349 (0.00%)
Tooth abscess † 1	1/336 (0.30%)	0/349 (0.00%)
Tooth infection † 1	1/336 (0.30%)	0/349 (0.00%)
Tracheitis † 1	0/336 (0.00%)	1/349 (0.29%)
Urinary tract infection † 1	1/336 (0.30%)	0/349 (0.00%)
Hepatitis E † 1	0/336 (0.00%)	1/349 (0.29%)
Injury, poisoning and procedural complications
Osteoradionecrosis † 1	6/336 (1.79%)	1/349 (0.29%)
Tracheostomy malfunction † 1	1/336 (0.30%)	3/349 (0.86%)
Radiation mucositis † 1	1/336 (0.30%)	2/349 (0.57%)
Fall † 1	1/336 (0.30%)	1/349 (0.29%)
Anastomotic stenosis † 1	1/336 (0.30%)	0/349 (0.00%)
Ankle fracture † 1	1/336 (0.30%)	0/349 (0.00%)
Feeding tube complication † 1	1/336 (0.30%)	0/349 (0.00%)
Femur fracture † 1	1/336 (0.30%)	0/349 (0.00%)
Fibula fracture † 1	0/336 (0.00%)	1/349 (0.29%)
Foreign body † 1	1/336 (0.30%)	0/349 (0.00%)
Implant tissue necrosis † 1	0/336 (0.00%)	1/349 (0.29%)
Limb injury † 1	0/336 (0.00%)	1/349 (0.29%)
Post procedural haemorrhage † 1	1/336 (0.30%)	0/349 (0.00%)
Radiation sickness syndrome † 1	1/336 (0.30%)	0/349 (0.00%)
Tibia fracture † 1	0/336 (0.00%)	1/349 (0.29%)
Traumatic fracture † 1	1/336 (0.30%)	0/349 (0.00%)
Upper limb fracture † 1	0/336 (0.00%)	1/349 (0.29%)
Wound complication † 1	0/336 (0.00%)	1/349 (0.29%)
Wound dehiscence † 1	1/336 (0.30%)	0/349 (0.00%)
Investigations
Ejection fraction decreased † 1	3/336 (0.89%)	10/349 (2.87%)
Blood creatinine increased † 1	2/336 (0.60%)	5/349 (1.43%)
Hepatic enzyme increased † 1	2/336 (0.60%)	3/349 (0.86%)
Weight decreased † 1	1/336 (0.30%)	4/349 (1.15%)
Alanine aminotransferase increased † 1	3/336 (0.89%)	1/349 (0.29%)
Blood uric acid increased † 1	1/336 (0.30%)	2/349 (0.57%)
Aspartate aminotransferase increased † 1	2/336 (0.60%)	0/349 (0.00%)
Glomerular filtration rate decreased † 1	1/336 (0.30%)	1/349 (0.29%)
Alanine aminotransferase abnormal † 1	0/336 (0.00%)	1/349 (0.29%)
Blood bilirubin abnormal † 1	0/336 (0.00%)	1/349 (0.29%)
Calcium ionised decreased † 1	0/336 (0.00%)	1/349 (0.29%)
Electrocardiogram abnormal † 1	0/336 (0.00%)	1/349 (0.29%)
Electrocardiogram change † 1	0/336 (0.00%)	1/349 (0.29%)
Gamma-glutamyltransferase increased † 1	0/336 (0.00%)	1/349 (0.29%)
Metabolism and nutrition disorders
Hyponatraemia † 1	6/336 (1.79%)	12/349 (3.44%)
Dehydration † 1	5/336 (1.49%)	6/349 (1.72%)
Hyperuricaemia † 1	4/336 (1.19%)	3/349 (0.86%)
Hypokalaemia † 1	2/336 (0.60%)	5/349 (1.43%)
Decreased appetite † 1	3/336 (0.89%)	3/349 (0.86%)
Malnutrition † 1	2/336 (0.60%)	4/349 (1.15%)
Electrolyte imbalance † 1	2/336 (0.60%)	1/349 (0.29%)
Hypercalcaemia † 1	2/336 (0.60%)	1/349 (0.29%)
Hyperkalaemia † 1	0/336 (0.00%)	3/349 (0.86%)
Hypocalcaemia † 1	0/336 (0.00%)	3/349 (0.86%)
Feeding disorder † 1	0/336 (0.00%)	2/349 (0.57%)
Hypernatraemia † 1	0/336 (0.00%)	1/349 (0.29%)
Hypophagia † 1	0/336 (0.00%)	1/349 (0.29%)
Metabolic disorder † 1	0/336 (0.00%)	1/349 (0.29%)
Musculoskeletal and connective tissue disorders
Neck pain † 1	1/336 (0.30%)	2/349 (0.57%)
Osteonecrosis † 1	3/336 (0.89%)	0/349 (0.00%)
Fistula † 1	1/336 (0.30%)	1/349 (0.29%)
Back pain † 1	0/336 (0.00%)	1/349 (0.29%)
Joint range of motion decreased † 1	0/336 (0.00%)	1/349 (0.29%)
Myalgia † 1	1/336 (0.30%)	1/349 (0.29%)
Pain in jaw † 1	1/336 (0.30%)	0/349 (0.00%)
Pathological fracture † 1	1/336 (0.30%)	0/349 (0.00%)
Temporomandibular joint syndrome † 1	1/336 (0.30%)	0/349 (0.00%)
Trismus † 1	0/336 (0.00%)	1/349 (0.29%)
Trismus † 1	1/336 (0.30%)	1/349 (0.29%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia † 1	1/336 (0.30%)	0/349 (0.00%)
Breast cancer † 1	0/336 (0.00%)	1/349 (0.29%)
Bronchial carcinoma † 1	0/336 (0.00%)	1/349 (0.29%)
Lung neoplasm † 1	0/336 (0.00%)	1/349 (0.29%)
Lung neoplasm malignant † 1	0/336 (0.00%)	1/349 (0.29%)
Neoplasm recurrence † 1	1/336 (0.30%)	0/349 (0.00%)
Oesophageal carcinoma † 1	1/336 (0.30%)	0/349 (0.00%)
Oesophageal neoplasm † 1	1/336 (0.30%)	0/349 (0.00%)
Oral fibroma † 1	1/336 (0.30%)	0/349 (0.00%)
Pancreatic carcinoma † 1	1/336 (0.30%)	0/349 (0.00%)
Prostate cancer † 1	1/336 (0.30%)	0/349 (0.00%)
Second primary malignancy † 1	0/336 (0.00%)	1/349 (0.29%)
Oral neoplasm † 1	0/336 (0.00%)	1/349 (0.29%)
Squamous cell carcinoma of the oral cavity † 1	0/336 (0.00%)	1/349 (0.29%)
Testis cancer † 1	0/336 (0.00%)	1/349 (0.29%)
Nervous system disorders
Syncope † 1	2/336 (0.60%)	1/349 (0.29%)
Cerebral ischaemia † 1	0/336 (0.00%)	2/349 (0.57%)
Ataxia † 1	0/336 (0.00%)	1/349 (0.29%)
Brain hypoxia † 1	1/336 (0.30%)	0/349 (0.00%)
Brain injury † 1	0/336 (0.00%)	1/349 (0.29%)
Cerebral infarction † 1	1/336 (0.30%)	0/349 (0.00%)
Convulsion † 1	1/336 (0.30%)	0/349 (0.00%)
Dizziness † 1	0/336 (0.00%)	1/349 (0.29%)
Dysgeusia † 1	0/336 (0.00%)	1/349 (0.29%)
Dyskinesia † 1	1/336 (0.30%)	0/349 (0.00%)
Grand mal convulsion † 1	0/336 (0.00%)	1/349 (0.29%)
Paralysis † 1	0/336 (0.00%)	1/349 (0.29%)
Subarachnoid haemorrhage † 1	1/336 (0.30%)	0/349 (0.00%)
Psychiatric disorders
Depression † 1	1/336 (0.30%)	2/349 (0.57%)
Completed suicide † 1	1/336 (0.30%)	1/349 (0.29%)
Suicide attempt † 1	1/336 (0.30%)	1/349 (0.29%)
Confusional state † 1	1/336 (0.30%)	0/349 (0.00%)
Renal and urinary disorders
Renal failure † 1	1/336 (0.30%)	3/349 (0.86%)
Renal failure acute † 1	3/336 (0.89%)	0/349 (0.00%)
Renal impairment † 1	1/336 (0.30%)	2/349 (0.57%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure † 1	2/336 (0.60%)	2/349 (0.57%)
Dyspnoea † 1	1/336 (0.30%)	3/349 (0.86%)
Pharyngeal fistula † 1	2/336 (0.60%)	2/349 (0.57%)
Pneumonia aspiration † 1	2/336 (0.60%)	2/349 (0.57%)
Pulmonary embolism † 1	3/336 (0.89%)	1/349 (0.29%)
Laryngeal oedema † 1	3/336 (0.89%)	0/349 (0.00%)
Epistaxis † 1	0/336 (0.00%)	2/349 (0.57%)
Haemoptysis † 1	1/336 (0.30%)	1/349 (0.29%)
Laryngeal stenosis † 1	1/336 (0.30%)	1/349 (0.29%)
Pneumonitis † 1	1/336 (0.30%)	1/349 (0.29%)
Respiratory disorder † 1	1/336 (0.30%)	1/349 (0.29%)
Respiratory distress † 1	2/336 (0.60%)	0/349 (0.00%)
Aspiration † 1	0/336 (0.00%)	1/349 (0.29%)
Chronic obstructive pulmonary disease † 1	0/336 (0.00%)	1/349 (0.29%)
Cough † 1	1/336 (0.30%)	0/349 (0.00%)
Dysphonia † 1	0/336 (0.00%)	1/349 (0.29%)
Laryngeal disorder † 1	1/336 (0.30%)	0/349 (0.00%)
Lung disorder † 1	0/336 (0.00%)	1/349 (0.29%)
Pharyngeal inflammation † 1	1/336 (0.30%)	0/349 (0.00%)
Pharyngeal stenosis † 1	0/336 (0.00%)	1/349 (0.29%)
Pleural effusion † 1	1/336 (0.30%)	0/349 (0.00%)
Pleurisy † 1	1/336 (0.30%)	0/349 (0.00%)
Pneumothorax † 1	1/336 (0.30%)	0/349 (0.00%)
Respiratory failure † 1	1/336 (0.30%)	0/349 (0.00%)
Skin and subcutaneous tissue disorders
Rash † 1	2/336 (0.60%)	4/349 (1.15%)
Skin reaction † 1	3/336 (0.89%)	0/349 (0.00%)
Ecchymosis † 1	1/336 (0.30%)	0/349 (0.00%)
Pemphigus † 1	1/336 (0.30%)	0/349 (0.00%)
Swelling face † 1	0/336 (0.00%)	1/349 (0.29%)
Vascular disorders
Haematoma † 1	1/336 (0.30%)	1/349 (0.29%)
Hypertension † 1	2/336 (0.60%)	0/349 (0.00%)
Arterial rupture † 1	1/336 (0.30%)	0/349 (0.00%)
Arterial thrombosis † 1	1/336 (0.30%)	0/349 (0.00%)
Deep vein thrombosis † 1	1/336 (0.30%)	0/349 (0.00%)
Femoral artery occlusion † 1	1/336 (0.30%)	0/349 (0.00%)
Haemorrhage † 1	0/336 (0.00%)	1/349 (0.29%)
Superior vena cava syndrome † 1	1/336 (0.30%)	0/349 (0.00%)
Venous thrombosis † 1	0/336 (0.00%)	1/349 (0.29%)
Venous thrombosis limb † 1	1/336 (0.30%)	0/349 (0.00%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo	Lapatinib 1500 mg
	Affected / at Risk (%)	Affected / at Risk (%)
Total	321/336 (95.54%)	337/349 (96.56%)
Blood and lymphatic system disorders
Anaemia † 1	61/336 (18.15%)	77/349 (22.06%)
Leukopenia † 1	99/336 (29.46%)	83/349 (23.78%)
Lymphopenia † 1	75/336 (22.32%)	87/349 (24.93%)
Neutropenia † 1	77/336 (22.92%)	70/349 (20.06%)
Thrombocytopenia † 1	25/336 (7.44%)	24/349 (6.88%)
Gastrointestinal disorders
Constipation † 1	74/336 (22.02%)	60/349 (17.19%)
Diarrhoea † 1	41/336 (12.20%)	147/349 (42.12%)
Dry mouth † 1	131/336 (38.99%)	148/349 (42.41%)
Dyspepsia † 1	21/336 (6.25%)	30/349 (8.60%)
Dysphagia † 1	113/336 (33.63%)	125/349 (35.82%)
Nausea † 1	150/336 (44.64%)	181/349 (51.86%)
Odynophagia † 1	34/336 (10.12%)	41/349 (11.75%)
Oral pain † 1	35/336 (10.42%)	25/349 (7.16%)
Stomatitis † 1	50/336 (14.88%)	50/349 (14.33%)
Vomiting † 1	115/336 (34.23%)	154/349 (44.13%)
General disorders
Asthenia † 1	45/336 (13.39%)	59/349 (16.91%)
Fatigue † 1	36/336 (10.71%)	41/349 (11.75%)
Mucosal inflammation † 1	208/336 (61.90%)	220/349 (63.04%)
Pyrexia † 1	60/336 (17.86%)	63/349 (18.05%)
Infections and infestations
Oral candidiasis † 1	22/336 (6.55%)	17/349 (4.87%)
Injury, poisoning and procedural complications
Radiation mucositis † 1	19/336 (5.65%)	13/349 (3.72%)
Radiation skin injury † 1	79/336 (23.51%)	55/349 (15.76%)
Investigations
Alanine aminotransferase increased † 1	31/336 (9.23%)	30/349 (8.60%)
Aspartate aminotransferase increased † 1	28/336 (8.33%)	33/349 (9.46%)
Blood creatinine increased † 1	33/336 (9.82%)	44/349 (12.61%)
Creatinine renal clearance decreased † 1	17/336 (5.06%)	27/349 (7.74%)
Haemoglobin decreased † 1	29/336 (8.63%)	33/349 (9.46%)
Lymphocyte count decreased † 1	18/336 (5.36%)	20/349 (5.73%)
Weight decreased † 1	64/336 (19.05%)	90/349 (25.79%)
White blood cell count decreased † 1	23/336 (6.85%)	30/349 (8.60%)
Metabolism and nutrition disorders
Decreased appetite † 1	69/336 (20.54%)	62/349 (17.77%)
Hypokalaemia † 1	28/336 (8.33%)	42/349 (12.03%)
Hyponatraemia † 1	25/336 (7.44%)	33/349 (9.46%)
Musculoskeletal and connective tissue disorders
Musculoskeletal pain † 1	23/336 (6.85%)	15/349 (4.30%)
Neck pain † 1	28/336 (8.33%)	20/349 (5.73%)
Nervous system disorders
Dysgeusia † 1	45/336 (13.39%)	31/349 (8.88%)
Headache † 1	28/336 (8.33%)	20/349 (5.73%)
Psychiatric disorders
Insomnia † 1	20/336 (5.95%)	17/349 (4.87%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	37/336 (11.01%)	45/349 (12.89%)
Dysphonia † 1	21/336 (6.25%)	23/349 (6.59%)
Oropharyngeal pain † 1	67/336 (19.94%)	45/349 (12.89%)
Productive cough † 1	36/336 (10.71%)	25/349 (7.16%)
Skin and subcutaneous tissue disorders
Pruritus † 1	9/336 (2.68%)	23/349 (6.59%)
Rash † 1	101/336 (30.06%)	167/349 (47.85%)
Skin reaction † 1	37/336 (11.01%)	41/349 (11.75%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

• Name/Title: GSK Response Center
• Organization: GlaxoSmithKline
• Phone: 866-435-7343

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Harrington K, Temam S, Mehanna H, D'Cruz A, Jain M, D'Onofrio I, Manikhas G, Horvath Z, Sun Y, Dietzsch S, Dubinsky P, Holeckova P, El-Hariry I, Franklin N, Biswas-Baldwin N, Legenne P, Wissel P, Netherway T, Farrell J, Ellis C, Wang-Silvanto J, Amonkar M, Ahmed N, Santillana S, Bourhis J. Postoperative Adjuvant Lapatinib and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib Monotherapy in High-Risk Patients With Resected Squamous Cell Carcinoma of the Head and Neck: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study. J Clin Oncol. 2015 Dec 10;33(35):4202-9. doi: 10.1200/JCO.2015.61.4370. Epub 2015 Nov 2.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00424255
• Other Study ID Numbers: EGF102988
• First Submitted: January 17, 2007
• First Posted: January 19, 2007
• Results First Submitted: November 27, 2013
• Results First Posted: February 11, 2014
• Last Update Posted: July 18, 2014