Trial Outcomes & Findings for A Study Of Lapatinib Versus Placebo Followed By Chemoradiation In Patients With Locally Advanced Head And Neck Cancer (NCT NCT00371566)
NCT ID: NCT00371566
Last Updated: 2010-04-06
Results Overview
Apoptotic Index-TUNEL Assay is a method which counts a total of at least 1000 neoplastic nuclei(Cells with morphological changes defining cell death) subdivided in 10 fields chosen randomly at 400x magnification. A 'responder' was defined as having 20% cell death.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
107 participants
Primary outcome timeframe
Baseline and Week 2
Results posted on
2010-04-06
Participant Flow
Participant milestones
| Measure |
Placebo
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the institutions standard of care)
|
Lapatinib
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Treatment Phase
STARTED
|
36
|
71
|
|
Treatment Phase
COMPLETED
|
36
|
68
|
|
Treatment Phase
NOT COMPLETED
|
0
|
3
|
|
Chemoradiation Phase
STARTED
|
36
|
68
|
|
Chemoradiation Phase
COMPLETED
|
31
|
65
|
|
Chemoradiation Phase
NOT COMPLETED
|
5
|
3
|
|
Follow Up Phase
STARTED
|
31
|
65
|
|
Follow Up Phase
COMPLETED
|
28
|
58
|
|
Follow Up Phase
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the institutions standard of care)
|
Lapatinib
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Treatment Phase
Withdrawal by Subject
|
0
|
1
|
|
Treatment Phase
Adverse Event
|
0
|
1
|
|
Treatment Phase
Protocol Violation
|
0
|
1
|
|
Chemoradiation Phase
Physician Decision
|
2
|
0
|
|
Chemoradiation Phase
Withdrawal by Subject
|
0
|
1
|
|
Chemoradiation Phase
Non compliant
|
0
|
1
|
|
Chemoradiation Phase
Progressive Disease
|
1
|
1
|
|
Chemoradiation Phase
Death
|
2
|
0
|
|
Follow Up Phase
Death
|
0
|
5
|
|
Follow Up Phase
Disease progression
|
1
|
0
|
|
Follow Up Phase
Withdrawal by Subject
|
0
|
1
|
|
Follow Up Phase
Physician Decision
|
1
|
1
|
|
Follow Up Phase
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Study Of Lapatinib Versus Placebo Followed By Chemoradiation In Patients With Locally Advanced Head And Neck Cancer
Baseline characteristics by cohort
| Measure |
Placebo
n=36 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=71 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
56.2 years
STANDARD_DEVIATION 10.47 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 11.01 • n=7 Participants
|
57.1 years
STANDARD_DEVIATION 10.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
21 participants
n=5 Participants
|
39 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 participants
n=5 Participants
|
11 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Central and South Asian Heritage
|
9 participants
n=5 Participants
|
19 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Japanese East/South east Heritage
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Mixed Heritage
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 2Population: The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.
Apoptotic Index-TUNEL Assay is a method which counts a total of at least 1000 neoplastic nuclei(Cells with morphological changes defining cell death) subdivided in 10 fields chosen randomly at 400x magnification. A 'responder' was defined as having 20% cell death.
Outcome measures
| Measure |
Placebo
n=27 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=57 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Change From Baseline of the Apoptotic Index During Treatment Phase
|
6.2 Percentage of positive cells
Standard Deviation 12.10
|
4.2 Percentage of positive cells
Standard Deviation 5.53
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: The mITT (modified Intent-to-Treat) population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumor biopsy sample for the primary endpoint analysis.
The Ki-67 protein is expressed in all phases of the cell cycle except G0 (low level phase) and serves as a good marker for cell proliferation. Scoring is assessed by point counting 500 to 1000 cells, and is reported as percent positive cells. 20% positive cells to define "positive" (i.e. high risk)
Outcome measures
| Measure |
Placebo
n=27 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=57 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Change From Baseline of Cell Proliferation Rate of the Ki-67 Proliferative Index in Tumour Biopsy Samples During Treatment Phase
|
-1.2 Percent of positive cells
Standard Deviation 7.90
|
-5.6 Percent of positive cells
Standard Deviation 12.53
|
SECONDARY outcome
Timeframe: Baseline and End of Treatment (Week 2 - 6)Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.
Over all: Complete Response (CR)- absence of lesions. Partial Response (PR)- CR or PR of target lesions and incomplete response (IC) or stable disease (SD) in other lesions with no new lesions or progressive disease (PD). Stable Disease (SD)-no PD or Response. Progressive Disease (PD)-PD or new lesions. Not Evaluable(NE)- no other definitions. Number of subjects included those who had a scan immediately post lapatanib/placebo monotherapy.
Outcome measures
| Measure |
Placebo
n=12 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=20 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Overall Radiological Response After Treatment Phase in mITT Population
Complete Response
|
0 Participants
|
1 Participants
|
|
Overall Radiological Response After Treatment Phase in mITT Population
Stable Disease
|
10 Participants
|
12 Participants
|
|
Overall Radiological Response After Treatment Phase in mITT Population
Progressive Disease
|
2 Participants
|
0 Participants
|
|
Overall Radiological Response After Treatment Phase in mITT Population
Partial Response
|
0 Participants
|
3 Participants
|
|
Overall Radiological Response After Treatment Phase in mITT Population
Non-Evaluable
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline and End of Follow-up (Week 19 - 25)Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.
Over all: Complete Response(CR)-absence of lesions. Partial Response(PR)- CR or PR of target lesions and incomplete response (IC) or stable disease (SD)in other lesions with no new lesions or progressive disease (PD). Stable Disease(SD)-no PD or Response. Progressive Disease(PD)-PD or new lesions. Not Evaluable(NE)- no other definitions. Number of subjects included those who were considered evaluable if they completed a full course of chemoradiotherapy and were able to provide a baseline and follow-up scan following the completion of chemoradiation.
Outcome measures
| Measure |
Placebo
n=23 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=47 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Overall Radiological Response After Follow-up Phase in mITT Population
Complete Response
|
2 Participants
|
11 Participants
|
|
Overall Radiological Response After Follow-up Phase in mITT Population
Partial Response
|
13 Participants
|
29 Participants
|
|
Overall Radiological Response After Follow-up Phase in mITT Population
Stable Disease
|
2 Participants
|
3 Participants
|
|
Overall Radiological Response After Follow-up Phase in mITT Population
Progressive Disease
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline and End of Treatment (Week 2 - 6)Population: The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.
Over all: Complete Response (CR)-absence of lesions. Partial Response (PR)- CR or PR of target lesions and incomplete response (IC) or stable disease (SD) in other lesions with no new lesions or progressive disease (PD). Stable Disease (SD)-no PD or Response. Progressive Disease (PD)-PD or new lesions. Not Evaluable(NE)- no other definitions.
Outcome measures
| Measure |
Placebo
n=16 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=24 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Overall Radiological Response After Treatment Phase in ITT Population
Non-Evaluable
|
0 Participants
|
5 Participants
|
|
Overall Radiological Response After Treatment Phase in ITT Population
Complete Response
|
0 Participants
|
1 Participants
|
|
Overall Radiological Response After Treatment Phase in ITT Population
Partial Response
|
0 Participants
|
3 Participants
|
|
Overall Radiological Response After Treatment Phase in ITT Population
Stable Disease
|
12 Participants
|
15 Participants
|
|
Overall Radiological Response After Treatment Phase in ITT Population
Progressive Disease
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and End of Follow-up (week 19 - 25)Population: The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.
Over all: Complete Response (CR) - absence of lesions. Partial Response (PR) - CR or PR of target lesions and incomplete response (IC) or stable disease (SD) in other lesions with no new lesions or progressive disease (PD). Stable Disease (SD)- no PD or Response. Progressive Disease (PD)- PD or new lesions. Not Evaluable(NE)- no other definitions.
Outcome measures
| Measure |
Placebo
n=30 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=58 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Overall Radiological Response After Follow-up Phase in ITT Population
Complete Response
|
2 Participants
|
16 Participants
|
|
Overall Radiological Response After Follow-up Phase in ITT Population
Partial Response
|
17 Participants
|
34 Participants
|
|
Overall Radiological Response After Follow-up Phase in ITT Population
Stable Disease
|
2 Participants
|
4 Participants
|
|
Overall Radiological Response After Follow-up Phase in ITT Population
Progressive Disease
|
9 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. mITT FOLLOW-UP Population of Circulation Tumor Cells
This measures the participants with Circulating Tumor Cells (CTC's)Pre-Treatment numbers of 0 to \>= 4. CTC's are tumor cells that escape from the primary tumor into the bloodstream and travel through the circulation to distant sites where they develop into secondary tumors.
Outcome measures
| Measure |
Placebo
n=12 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=22 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Number of Circulating Tumor Cells at Baseline in mITT Population
Number of CTC's 1
|
2 Participants
|
1 Participants
|
|
Number of Circulating Tumor Cells at Baseline in mITT Population
Number of CTC's 2
|
1 Participants
|
0 Participants
|
|
Number of Circulating Tumor Cells at Baseline in mITT Population
Number of CTC's ≥4
|
0 Participants
|
1 Participants
|
|
Number of Circulating Tumor Cells at Baseline in mITT Population
No result
|
2 Participants
|
2 Participants
|
|
Number of Circulating Tumor Cells at Baseline in mITT Population
Number of CTC's 0
|
7 Participants
|
18 Participants
|
|
Number of Circulating Tumor Cells at Baseline in mITT Population
Number of CTC's 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: End of Treatment (week 2 - 6)Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.
This measures the participants with Circulating Tumor Cells (CTC's) after treatment numbers of 0 to \>= 4. CTC's are tumor cells that escape from the primary tumor into the bloodstream and travel through the circulation to distant sites where they develop into secondary tumors.
Outcome measures
| Measure |
Placebo
n=13 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=19 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Number of Participants With Circulating Tumor Cells After Treatment Phase in mITT Population
Number of CTC's >=4
|
0 Participants
|
2 Participants
|
|
Number of Participants With Circulating Tumor Cells After Treatment Phase in mITT Population
Number of CTC's 0
|
12 Participants
|
13 Participants
|
|
Number of Participants With Circulating Tumor Cells After Treatment Phase in mITT Population
Number of CTC's 1
|
0 Participants
|
3 Participants
|
|
Number of Participants With Circulating Tumor Cells After Treatment Phase in mITT Population
Number of CTC's 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Circulating Tumor Cells After Treatment Phase in mITT Population
Number of CTC's 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Circulating Tumor Cells After Treatment Phase in mITT Population
No result
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: End of Chemoradiotherapy (week 10 - 13)Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.
This measures the participants with Circulating Tumor Cells (CTC's) after chemoradiotherapy numbers of 0 to \>= 4. CTC's are tumor cells that escape from the primary tumor into the bloodstream and travel through the circulation to distant sites where they develop into secondary tumors.
Outcome measures
| Measure |
Placebo
n=5 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=2 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Number of Participants With Circulating Tumor Cells After Chemoradiotherapy Phase in mITT Population
Number of CTC's 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Circulating Tumor Cells After Chemoradiotherapy Phase in mITT Population
Number of CTC's 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Circulating Tumor Cells After Chemoradiotherapy Phase in mITT Population
Number of CTC's 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Circulating Tumor Cells After Chemoradiotherapy Phase in mITT Population
Number of CTC's >=4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Circulating Tumor Cells After Chemoradiotherapy Phase in mITT Population
Number of CTC's 0
|
4 Participants
|
2 Participants
|
|
Number of Participants With Circulating Tumor Cells After Chemoradiotherapy Phase in mITT Population
No result
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.
Estrogen Receptor (ER) variants, ERB-B2 and ERB B-5 consist of the major proportion of ER expression both in normal and cancer tissues. The exact role of these markers are unknown. Acronyms defined: ICH (immunohistochemical) and FISH (fluorescence in situ hybridization).
Outcome measures
| Measure |
Placebo
n=27 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=57 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB1 by IHC-Baseline 3+ expressed
|
23 Participants
|
45 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB1 by IHC-Treatment 3+ expressed
|
23 Participants
|
48 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB1 by FISH-Treatment Non Amplified
|
0 Participants
|
0 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB2 by IHC-Baseline 0 expressed
|
19 Participants
|
42 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB2 by IHC-Treatment 0 expressed
|
15 Participants
|
26 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB2 by IHC-Treatment 1+ expressed
|
11 Participants
|
29 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB2 by IHC-Treatment 3+ expressed
|
0 Participants
|
1 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB2 by FISH-Baseline Amplified
|
2 Participants
|
1 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
pErbB1 by IHC-Baseline 0 expressed
|
0 Participants
|
3 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
pErbB1 by IHC-Baseline 1+ expressed
|
13 Participants
|
31 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
pErbB1 by IHC-Baseline 3+ expressed
|
3 Participants
|
5 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
pErbB1 by IHC-Treatment 3+ expressed
|
2 Participants
|
1 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
pErbB2 by IHC-Baseline 0 expressed
|
13 Participants
|
25 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
pErbB2 by IHC-Treatment 0 expressed
|
13 Participants
|
24 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
pErbB2 by IHC-Baseline 1+ expressed
|
12 Participants
|
30 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
pErbB2 by IHC-Treatment 1+ expressed
|
12 Participants
|
29 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
pErbB2 by IHC-Treatment 3+ expressed
|
0 Participants
|
0 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
pErbB2 by IHC-Baseline - Missing expression
|
1 Participants
|
1 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
pErbB2 by IHC-Treatment Missing expression
|
1 Participants
|
0 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB1 by IHC-Baseline 0 expressed
|
2 Participants
|
0 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB1 by IHC-Treatment 0 expressed
|
2 Participants
|
0 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB1 by IHC-Baseline 1+ expressed
|
2 Participants
|
2 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB1 by IHC-Treatment 1+ expressed
|
1 Participants
|
4 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB1 by IHC-Baseline 2+ expressed
|
0 Participants
|
10 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB1 by IHC-Treatment 2+ expressed
|
1 Participants
|
5 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB1 by FISH-Baseline Amplified
|
8 Participants
|
17 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB1 by FISH-Treatment Amplified
|
0 Participants
|
0 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB1 by FISH-Baseline Non Amplified
|
19 Participants
|
40 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB2 by IHC-Baseline 1+ expressed
|
6 Participants
|
13 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB2 by IHC-Baseline 2+ expressed
|
2 Participants
|
1 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB2 by IHC-Treatment 2+ expressed
|
1 Participants
|
1 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB2 by IHC-Baseline 3+ expressed
|
0 Participants
|
1 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB2 by FISH-Treatment Amplified
|
0 Participants
|
0 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB2 by FISH-Baseline Non Amplified
|
25 Participants
|
54 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
ErbB2 by FISH-Treatment Non Amplified
|
0 Participants
|
2 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
pErbB1 by IHC-Treatment 1+ expressed
|
14 Participants
|
38 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
pErbB1 by IHC-Baseline 2+ expressed
|
11 Participants
|
18 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
pErbB1 by IHC-Treatment 2+ expressed
|
11 Participants
|
15 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
pErbB2 by IHC-Baseline 2+ expressed
|
1 Participants
|
1 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
pErbB2 by IHC-Treatment 2+ expressed
|
1 Participants
|
4 Participants
|
|
Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase
pErbB2 by IHC-Baseline 3+ expressed
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 2Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.
Tumor Suppressor p53 is welcomed and described as "the guardian angel gene," it conserves stability by preventing genome mutation. Human Papillomavirus (HPV) biomarker is un-welcomed and is found to be an important precursor cancers of the head and neck. HPV biomarkers have the ability to bind to and inactivate the Tumor Suppressor p53 biomarker.
Outcome measures
| Measure |
Placebo
n=36 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=71 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Number of Biomarkers Including Tumor Protein 53 and HPV During Treatment Phase
Tumor Protein 53 - 3+ expression
|
14 Participants
|
19 Participants
|
|
Number of Biomarkers Including Tumor Protein 53 and HPV During Treatment Phase
Tumor Protein 53 - missing expression
|
0 Participants
|
0 Participants
|
|
Number of Biomarkers Including Tumor Protein 53 and HPV During Treatment Phase
HPV - Negative
|
36 Participants
|
64 Participants
|
|
Number of Biomarkers Including Tumor Protein 53 and HPV During Treatment Phase
HPV - Positive
|
0 Participants
|
5 Participants
|
|
Number of Biomarkers Including Tumor Protein 53 and HPV During Treatment Phase
Tumor Protein 53 - 0 expression
|
14 Participants
|
25 Participants
|
|
Number of Biomarkers Including Tumor Protein 53 and HPV During Treatment Phase
Tumor Protein 53 - 1+ expression
|
5 Participants
|
14 Participants
|
|
Number of Biomarkers Including Tumor Protein 53 and HPV During Treatment Phase
Tumor Protein 53 - 2+ expression
|
3 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Week 1 through Week 6Population: The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.
Toxicity Grading scale 0=none, 1=transient symptom, 2=mild symptom that does not interfere with activities of daily living (ADL's) 3=mild but interfers with ADL's w/o hospitalization. 4=requires hopitalization 5=Death.
Outcome measures
| Measure |
Placebo
n=36 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=69 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Acne - Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Diarrhea - Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Hyperglycaemia - Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Hyperglycaemia - Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Tumor Haemorrhage - Grade 3
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Tumor Haemorrhage - Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Rash - Grade 3
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Rash - Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Rash - Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Acne - Grade 3
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Acne - Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Diarrhea - Grade 3
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Diarrhea - Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Anaemia - Grade 3
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Anaemia - Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Anaemia - Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Hyperglycaemia - Grade 3
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Pain in jaw - Grade 3
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Pain in jaw - Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Pain in jaw - Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase
Tumor Haemorrhage - Grade 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 10 through 25Population: The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.
Toxicity Grading scale 0=none, 1= transient symptom, 2=mild symptom that does not interfere with activities of daily living (ADL's) 3=mild but interfers with ADL's w/o hospitalization. 4=requires hopitalization 5=Death.
Outcome measures
| Measure |
Placebo
n=36 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=69 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Intestinal Perforation-Grade 5
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Dyspnoea-Grade 3
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Skin Reaction-Grade 4
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Skin Reaction-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Neutropenia-Grade 3
|
3 Participants
|
4 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Neutropenia-Grade 4
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Neutropenia-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Asthenia-Grade 3
|
2 Participants
|
3 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Soft Tissue Inflamation-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Odynophagia-Grade 3
|
2 Participants
|
2 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Odynophagia-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Odynophagia-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
General Physical Health deterioration-Grade 3
|
0 Participants
|
2 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
General Physical Health deterioration-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
General Physical Health deterioration-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Rash-Grade 3
|
0 Participants
|
2 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Rash-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Radiation Skin Injury-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Dysphagia-Grade 3
|
3 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Nausea-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Stomatitis-Grade 3
|
1 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Pain-Grade 3
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Pain-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Constipation-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Constipation-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Skin Ulcer-Grade 3
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Dysphonia-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Dysphonia-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Leucopenia-Grade 3
|
2 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Leucopenia-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Leucopenia-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
AST increase-Grade 3
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
AST increase-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
AST increase-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Trimus-Grade 3
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Diplopia-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Diplopia-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Renal Failure-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Renal Failure-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Localized edema-Grade 3
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Respiratory tract infection-Grade 3
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Staphyloccocal sepsis-Grade 3
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Staphyloccocal sepsis-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Staphyloccocal sepsis-Grade 5
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Hyponatraemia-Grade 3
|
2 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Hyponatraemia-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Hypernatraemia-Grade 3
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Hypernatraemia-Grade 4
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Hypernatraemia-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Post Procedural Haemorrhage-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Blood Creatinine Increased-Grade 3
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Haematocrit decreased-Grade 3
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Haematocrit decreased-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Haematocrit decreased-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Haemoglobin decreased-Grade 3
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Haemoglobin decreased-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Ventricular Fibrillation-Grade 5
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Intestinal Perforation-Grade 3
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Dyspnoea-Grade 4
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Lymphopenia-Grade 3
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Lymphopenia-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Cardio-respiratory arrest-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Cardio-respiratory arrest-Grade 5
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Dyspnoea-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Anaemia-Grade 3
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Anaemia-Grade 4
|
0 Participants
|
2 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Anaemia-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Lymphopenia-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Cardio-respiratory arrest-Grade 3
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Mucosal Inflamation-Grade 3
|
3 Participants
|
24 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Mucosal Inflamation-Grade 4
|
0 Participants
|
2 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Mucosal Inflamation-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Skin Reaction-Grade 3
|
3 Participants
|
6 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Asthenia-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Asthenia-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Soft Tissue Inflamation-Grade 3
|
1 Participants
|
2 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Soft Tissue Inflamation-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Rash-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Radiation Skin Injury-Grade 3
|
0 Participants
|
2 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Radiation Skin Injury-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Dysphagia-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Dysphagia-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Nausea-Grade 3
|
1 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Nausea-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Stomatitis-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Stomatitis-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Radiation mucositis-Grade 3
|
2 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Radiation mucositis-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Radiation mucositis-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Weight decrease-Grade 3
|
1 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Weight decrease-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Weight decrease-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Pain-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Constipation-Grade 3
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Skin Ulcer-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Skin Ulcer-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Dysphonia-Grade 3
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Trimus-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Trimus-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Bipolar disorder-Grade 3
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Bipolar disorder-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Bipolar disorder-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Diplopia-Grade 3
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Peripheral Embolism-Grade 3
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Peripheral Embolism-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Peripheral Embolism-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Renal Failure-Grade 3
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Localized edema-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Localized edema-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Vomiting-Grade 3
|
3 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Vomiting-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Vomiting-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Respiratory failure-Grade 3
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Respiratory failure-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Respiratory failure-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Respiratory tract infection-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Respiratory tract infection-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Sepsis-Grade 3
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Sepsis-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Sepsis-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Hyponatraemia-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Ketoacidosis-Grade 3
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Ketoacidosis-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Ketoacidosis-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Post Procedural Haemorrhage-Grade 3
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Post Procedural Haemorrhage-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Blood Creatinine Increased-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Blood Creatinine Increased-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Haemoglobin decreased-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Back Pain-Grade 3
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Back Pain-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Back Pain-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Deep Vein Thrombosis-Grade 3
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Deep Vein Thrombosis-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Deep Vein Thrombosis-Grade 5
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Ventricular Fibrillation-Grade 3
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Ventricular Fibrillation-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Intestinal Perforation-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Sudden Death-Grade 3
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Sudden Death-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Sudden Death-Grade 5
|
0 Participants
|
1 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Dry Mouth-Grade 3
|
1 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Dry Mouth-Grade 4
|
0 Participants
|
0 Participants
|
|
Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase
Dry Mouth-Grade 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 2 - 4Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.
Position Emission Tomography (PET) scans 3-D images are read alongside CT or magnetic resonance imaging (MRI) scans, the combination gives both anatomic and metabolic information. CT = Computerized axial tomography; a type of x-ray for dense areas of the body. MRI = Magnetic Resonance Imaging which captures a picture using Magnets. Better = improvement in response, Worse = response was downgraded.
Outcome measures
| Measure |
Placebo
n=11 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=14 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Comparison of Overall Response During Treatment Phase Using CT/MRI and PET Information
Worse
|
0 Participants
|
3 Participants
|
|
Comparison of Overall Response During Treatment Phase Using CT/MRI and PET Information
Better
|
2 Participants
|
3 Participants
|
|
Comparison of Overall Response During Treatment Phase Using CT/MRI and PET Information
Same
|
8 Participants
|
6 Participants
|
|
Comparison of Overall Response During Treatment Phase Using CT/MRI and PET Information
Any Unknown
|
0 Participants
|
0 Participants
|
|
Comparison of Overall Response During Treatment Phase Using CT/MRI and PET Information
Missing
|
1 Participants
|
0 Participants
|
|
Comparison of Overall Response During Treatment Phase Using CT/MRI and PET Information
Not Evaluable
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: weeks 19 - 25Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.
Position Emission Tomography (PET) scans 3-D images are read alongside CT or magnetic resonance imaging (MRI) scans, the combination gives both anatomic and metabolic information. CT = Computerized axial tomography; a type of x-ray for dense areas of the body. MRI = Magnetic Resonance Imaging which captures a picture using Magnets. Better = improvement in response, Worse = response was downgraded.
Outcome measures
| Measure |
Placebo
n=13 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=17 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Comparison of Overall Response During Follow up Phase Using CT/MRI and PET Information
Same
|
11 Participants
|
10 Participants
|
|
Comparison of Overall Response During Follow up Phase Using CT/MRI and PET Information
Any Unknown
|
0 Participants
|
0 Participants
|
|
Comparison of Overall Response During Follow up Phase Using CT/MRI and PET Information
Missing
|
1 Participants
|
0 Participants
|
|
Comparison of Overall Response During Follow up Phase Using CT/MRI and PET Information
Better
|
0 Participants
|
2 Participants
|
|
Comparison of Overall Response During Follow up Phase Using CT/MRI and PET Information
Worse
|
1 Participants
|
5 Participants
|
|
Comparison of Overall Response During Follow up Phase Using CT/MRI and PET Information
Not Evaluable
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 1 through 25Population: Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
Definition of an adverse event is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Placebo
n=36 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=69 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group
Asthenia
|
17 Participants
|
21 Participants
|
|
Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group
Dysphagia
|
12 Participants
|
21 Participants
|
|
Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group
Vomiting
|
13 Participants
|
17 Participants
|
|
Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group
Mucosal Inflammation
|
24 Participants
|
48 Participants
|
|
Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group
Odynophagia
|
13 Participants
|
23 Participants
|
|
Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group
Nausea
|
8 Participants
|
20 Participants
|
|
Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group
Dry Mouth
|
8 Participants
|
15 Participants
|
|
Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group
Neutropenia
|
10 Participants
|
13 Participants
|
|
Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group
Radiation Skin Injury
|
8 Participants
|
13 Participants
|
|
Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group
Constipation
|
8 Participants
|
12 Participants
|
|
Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group
Skin Reaction
|
7 Participants
|
11 Participants
|
|
Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group
Pharyngolaryngeal Pain
|
6 Participants
|
11 Participants
|
|
Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group
Anorexia
|
11 Participants
|
10 Participants
|
|
Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group
Dysphonia
|
8 Participants
|
8 Participants
|
|
Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group
Pyrexia
|
6 Participants
|
6 Participants
|
|
Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group
Leukopenia
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 10 through 25Population: Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
Events which started during or After the Chemoradiotherapy Phase. Definition of a serious adverse event is any untoward medicinal occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other.
Outcome measures
| Measure |
Placebo
n=36 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=69 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Summary of Fatal/Serious Adverse Events During or After Chemoradiotherapy Phase
Intestinal perforation
|
0 Participants
|
1 Participants
|
|
Summary of Fatal/Serious Adverse Events During or After Chemoradiotherapy Phase
Cardio-respiratory arrest
|
0 Participants
|
1 Participants
|
|
Summary of Fatal/Serious Adverse Events During or After Chemoradiotherapy Phase
Respiratory tract infection
|
0 Participants
|
1 Participants
|
|
Summary of Fatal/Serious Adverse Events During or After Chemoradiotherapy Phase
Sudden death
|
0 Participants
|
1 Participants
|
|
Summary of Fatal/Serious Adverse Events During or After Chemoradiotherapy Phase
Ventricular fibrillation
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 10 through 25Population: Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
Events which started during or After Chemoradiotherapy Phase. Definition of a serious adverse event is any untoward medicinal occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other.
Outcome measures
| Measure |
Placebo
n=36 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=69 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Mucosal inflammation
|
2 Participants
|
3 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Constipation
|
0 Participants
|
2 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Asthenia
|
0 Participants
|
1 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Cardio-respiratory arrest
|
0 Participants
|
1 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Chronic obstructive pulmonary disease
|
0 Participants
|
1 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Dehydration
|
0 Participants
|
1 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
General physical health deterioration
|
0 Participants
|
1 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Respiratory tract infection
|
2 Participants
|
1 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Skin ulcer
|
0 Participants
|
1 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Sudden death
|
0 Participants
|
1 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Electrolyte imbalance
|
1 Participants
|
0 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Diabetic ketoacidosis
|
1 Participants
|
0 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Ketoacidosis
|
1 Participants
|
0 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Pyrexia
|
2 Participants
|
0 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Weight decreased
|
1 Participants
|
0 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Bipolar disorder
|
0 Participants
|
1 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Intestinal perforation
|
0 Participants
|
1 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Peripheral embolism
|
0 Participants
|
1 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Renal failure
|
0 Participants
|
1 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Lobar pneumonia
|
1 Participants
|
0 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Neutropenia
|
1 Participants
|
0 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Parotitis
|
1 Participants
|
0 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Pneumonia aspiration
|
1 Participants
|
0 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Post procedural haemorrhage
|
1 Participants
|
0 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Renal Impairment
|
1 Participants
|
0 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Sepsis
|
1 Participants
|
0 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Septic shock
|
1 Participants
|
0 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Upper respiratory tract infection
|
1 Participants
|
0 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Ventricular fibrillation
|
1 Participants
|
0 Participants
|
|
Summary of Serious Adverse Events During or After Chemoradiotherapy Phase
Vomiting
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 10 through 25Population: Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
Events which started during or after Chemoradiotherapy Phase. "Grade 3" are severe and undesirable Adverse Event (significant symptoms requiring hospitalization or invasive intervention; transfusion; elective interventional radiological procedure; therapeutic endoscopy or operation).
Outcome measures
| Measure |
Placebo
n=36 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=69 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
General physical health deterioration
|
0 Participants
|
2 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Nausea
|
1 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Stomatitis
|
1 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Radiation mucositis
|
2 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Constipation
|
0 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Peripheral embolism
|
0 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Haematocrit decreased
|
1 Participants
|
0 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Haemoglobin decreased
|
1 Participants
|
0 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Lymphopenia
|
1 Participants
|
0 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Dry mouth
|
1 Participants
|
0 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Mucosal inflammation
|
9 Participants
|
24 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Skin reaction
|
3 Participants
|
6 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Neutropenia
|
3 Participants
|
4 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Asthenia
|
2 Participants
|
3 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Soft tissue inflammation
|
1 Participants
|
2 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Odynophagia
|
2 Participants
|
2 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Rash
|
0 Participants
|
2 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Radiation skin injury
|
0 Participants
|
2 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Dysphagia
|
3 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Weight decreased
|
1 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Pain
|
0 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Skin ulcer
|
0 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Dysphonia
|
0 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Leucopenia
|
2 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Aspartate aminotransferase increased
|
0 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Trismus
|
0 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Bipolar disorder
|
0 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Diplopia
|
0 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Renal failure
|
0 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Localised oedema
|
1 Participants
|
0 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Vomiting
|
3 Participants
|
0 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Respiratory failure
|
1 Participants
|
0 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Respiratory tract infection
|
1 Participants
|
0 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Sepsis
|
1 Participants
|
0 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Hyponatraemia
|
2 Participants
|
0 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Ketoacidosis
|
1 Participants
|
0 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Post procedural haemorrhage
|
1 Participants
|
0 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Blood creatinine increased
|
1 Participants
|
0 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Back pain
|
1 Participants
|
0 Participants
|
|
Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase
Deep vein thrombosis
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 10 through 25Population: Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
Events which started during or after Chemoradiotherapy Phase. "Grade 4" are life-threatening or disabling Adverse Event (complicated by acute, life-threatening metabolic or cardiovascular complications such as circulatory failure, hemorrhage, sepsis. Life-threatening physiologic consequences; need for intensive care or emergent invasive procedure; emergent interventional radiological procedure, therapeutic endoscopy or operation).
Outcome measures
| Measure |
Placebo
n=36 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=69 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Adverse Events (AEs) by Maximum Toxicity Grade 4 During or After Chemoradiotherapy Phase
Mucosal inflammation
|
0 Participants
|
2 Participants
|
|
Adverse Events (AEs) by Maximum Toxicity Grade 4 During or After Chemoradiotherapy Phase
Neutropenia
|
1 Participants
|
0 Participants
|
|
Adverse Events (AEs) by Maximum Toxicity Grade 4 During or After Chemoradiotherapy Phase
Hypernatraemia
|
0 Participants
|
1 Participants
|
|
Adverse Events (AEs) by Maximum Toxicity Grade 4 During or After Chemoradiotherapy Phase
Dyspnoea
|
0 Participants
|
1 Participants
|
|
Adverse Events (AEs) by Maximum Toxicity Grade 4 During or After Chemoradiotherapy Phase
Skin reaction
|
0 Participants
|
1 Participants
|
|
Adverse Events (AEs) by Maximum Toxicity Grade 4 During or After Chemoradiotherapy Phase
Anaemia
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 10 through 25Population: Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
Events which started during or after Chemoradiotherapy Phase. "Grade 5" are death related to Adverse Event.
Outcome measures
| Measure |
Placebo
n=36 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=69 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Adverse Events by Maximum Toxicity Grade 5 During or After Chemoradiotherapy Phase
Intestinal perforation
|
0 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 5 During or After Chemoradiotherapy Phase
Respiratory tract infection
|
0 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 5 During or After Chemoradiotherapy Phase
Staphyloccocal sepsis
|
1 Participants
|
0 Participants
|
|
Adverse Events by Maximum Toxicity Grade 5 During or After Chemoradiotherapy Phase
Ventricular fibrillation
|
1 Participants
|
0 Participants
|
|
Adverse Events by Maximum Toxicity Grade 5 During or After Chemoradiotherapy Phase
Cardio-respiratory arrest
|
0 Participants
|
1 Participants
|
|
Adverse Events by Maximum Toxicity Grade 5 During or After Chemoradiotherapy Phase
Sudden death
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, and Week 2 - 4Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population
Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=4 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Relative Change From Baseline of Ktrans Median (1/Min) After 2 - 4 Weeks of Treatment
|
-2.70 Percent change
Standard Deviation 25.364
|
6.15 Percent change
Standard Deviation 22.792
|
SECONDARY outcome
Timeframe: Baseline, and Week 2 - 4Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population
DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=4 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Relative Change From Baseline of Kep Mean (1/Min) After 2 - 4 Weeks of Treatment
|
10.30 Percent change
Standard Deviation 33.630
|
-14.54 Percent change
Standard Deviation 8.898
|
SECONDARY outcome
Timeframe: Baseline, and Week 2 - 4Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population
DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=4 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Relative Change From Baseline of Kep Perfused (1/Min) After 2 - 4 Weeks of Treatment
|
7.63 Percent change
Standard Deviation 26.965
|
-19.96 Percent change
Standard Deviation 8.662
|
SECONDARY outcome
Timeframe: Baseline, and Week 2 - 4Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population
DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=4 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Relative Change From Baseline of Kep Whole (1/Min) After 2 - 4 Weeks of Treatment
|
8.87 Percent change
Standard Deviation 29.875
|
-19.64 Percent change
Standard Deviation 6.716
|
SECONDARY outcome
Timeframe: Baseline, and Week 2 - 4Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population
Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=4 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Relative Change From Baseline of Ktrans Mean (1/Min) After 2 - 4 Weeks of Treatment
|
-1.90 Percent change
Standard Deviation 27.965
|
4.02 Percent change
Standard Deviation 17.683
|
SECONDARY outcome
Timeframe: Baseline, and Week 2 - 4Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population
Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=4 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Relative Change From Baseline of Ktrans Perfused (1/Min) After 2 - 4 Weeks of Treatment
|
-1.44 Percent change
Standard Deviation 23.029
|
0.69 Percent change
Standard Deviation 34.213
|
SECONDARY outcome
Timeframe: Baseline, and Week 2 - 4Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population
Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=4 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Relative Change From Baseline of Ktrans Whole (1/Min) After 2 - 4 Weeks of Treatment
|
-2.02 Percent change
Standard Deviation 20.971
|
0.30 Percent change
Standard Deviation 31.783
|
SECONDARY outcome
Timeframe: Baseline, and Week 2 - 4Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population
Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=4 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Relative Change From Baseline of IAUC Median (90) After 2 - 4 Weeks of Treatment
|
-2.07 Percent change
Standard Deviation 30.188
|
14.08 Percent change
Standard Deviation 23.998
|
SECONDARY outcome
Timeframe: Baseline, and Week 2 - 4Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population
Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=4 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Relative Change From Baseline of IAUC Mean (90) After 2 - 4 Weeks of Treatment
|
-3.30 Percent change
Standard Deviation 28.415
|
13.48 Percent change
Standard Deviation 20.763
|
SECONDARY outcome
Timeframe: Baseline, and Week 2 - 4Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population
Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=4 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Relative Change From Baseline of Perfused IAUC (90) After 2 - 4 Weeks of Treatment
|
-2.40 Percent change
Standard Deviation 29.521
|
12.57 Percent change
Standard Deviation 28.722
|
SECONDARY outcome
Timeframe: Baseline, and Week 2 - 4Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population
Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=4 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Relative Change From Baseline of Whole IAUC(90) After 2 - 4 Weeks of Treatment
|
-2.43 Percent change
Standard Deviation 29.313
|
12.52 Percent change
Standard Deviation 28.974
|
SECONDARY outcome
Timeframe: Baseline, and Week 2 - 4Population: The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population
DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=4 Participants
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Relative Change From Baseline of Kep Median (1/Min) After 2 - 4 Weeks of Treatment
|
2.88 Percent change
Standard Deviation 19.177
|
-9.32 Percent change
Standard Deviation 10.002
|
Adverse Events
Placebo
Serious events: 14 serious events
Other events: 36 other events
Deaths: 0 deaths
Lapatinib
Serious events: 14 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=36 participants at risk
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=69 participants at risk
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of mor than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Infections and infestations
Pyrexia
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Musculoskeletal and connective tissue disorders
Abdominal strangulated hernia
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Mucosal Inflammation
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
4.3%
3/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
2.9%
2/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Infection
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Musculoskeletal and connective tissue disorders
Asthenia
|
0.00%
0/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
General disorders
General Physical Health deterioration
|
0.00%
0/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Investigations
Sudden Death
|
0.00%
0/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
General disorders
Dehydration
|
0.00%
0/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Psychiatric disorders
Bipolar Disorder
|
0.00%
0/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Cardiac disorders
Peripheral Embolism
|
0.00%
0/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Respiratory, thoracic and mediastinal disorders
Lobar Pneumonia
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Infections and infestations
Parotitis
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Blood and lymphatic system disorders
Sepsis
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Blood and lymphatic system disorders
Septic Shock
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Cardiac disorders
Ventricular Fibrillation
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Renal and urinary disorders
Renal Impairment
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspirations
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Metabolism and nutrition disorders
Weight Decrease
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Cardiac disorders
Ventricular fibrillation
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Renal and urinary disorders
Renal impairment
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Injury, poisoning and procedural complications
Post procedural hemorrhage
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Investigations
Weight decreased
|
2.8%
1/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
Other adverse events
| Measure |
Placebo
n=36 participants at risk
Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
|
Lapatinib
n=69 participants at risk
Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of mor than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
|
|---|---|---|
|
Gastrointestinal disorders
Mucosal inflammation
|
66.7%
24/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
69.6%
48/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Musculoskeletal and connective tissue disorders
Asthenia
|
47.2%
17/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
33.3%
23/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Odynophagia
|
36.1%
13/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
33.3%
23/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Dysphagia
|
36.1%
13/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
31.9%
22/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
9/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
30.4%
21/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.9%
5/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
30.4%
21/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Vomiting
|
38.9%
14/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
26.1%
18/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
26.1%
18/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Dry Mouth
|
22.2%
8/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
21.7%
15/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Metabolism and nutrition disorders
Anorexia
|
30.6%
11/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
20.3%
14/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Blood and lymphatic system disorders
Neutropenia
|
27.8%
10/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
18.8%
13/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Injury, poisoning and procedural complications
Radiation Skin Injury
|
22.2%
8/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
18.8%
13/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
9/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
17.4%
12/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
22.2%
8/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
11.6%
8/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
General disorders
Pain
|
16.7%
6/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
11.6%
8/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
General disorders
Pyrexia
|
16.7%
6/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
10.1%
7/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
General disorders
Soft tissue inflammation
|
8.3%
3/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
7.2%
5/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
General disorders
Oedema
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
4.3%
3/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
General disorders
Face oedema
|
8.3%
3/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Oral pain
|
8.3%
3/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
14.5%
10/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Stomatitis
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
7.2%
5/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
4.3%
3/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Aptyalism
|
0.00%
0/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
7.2%
5/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Toothache
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
4.3%
3/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
5.8%
4/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Mouth hemorrhage
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Gastrointestinal disorders
Oesophagitis
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
19.4%
7/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
15.9%
11/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
10.1%
7/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
2.9%
2/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Infections and infestations
Candidiasis
|
11.1%
4/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
5.8%
4/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Infections and infestations
Oral candidiasis
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
7.2%
5/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Infections and infestations
Respiratory tract infection
|
8.3%
3/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
8.3%
3/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
8.3%
3/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
4.3%
3/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
7.2%
5/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
16.7%
6/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
17.4%
12/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.9%
5/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
8.7%
6/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
4/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
2.9%
2/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Blood and lymphatic system disorders
Anemia
|
13.9%
5/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
14.5%
10/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Blood and lymphatic system disorders
Leukopenia
|
19.4%
7/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
5.8%
4/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
7.2%
5/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Blood and lymphatic system disorders
Weight decreased
|
13.9%
5/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
13.0%
9/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Blood and lymphatic system disorders
Blood creatinine increased
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
2.9%
2/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Nervous system disorders
Dysgeusia
|
11.1%
4/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
15.9%
11/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Nervous system disorders
Headache
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
4.3%
3/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Nervous system disorders
Paraesthesia
|
11.1%
4/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Injury, poisoning and procedural complications
Radiation mucositis
|
8.3%
3/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
7.2%
5/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
3/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
7.2%
5/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
7.2%
5/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Ear and labyrinth disorders
Hypoacusis
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
10.1%
7/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Ear and labyrinth disorders
Ear pain
|
11.1%
4/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
2.9%
2/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Ear and labyrinth disorders
Tinnitus
|
8.3%
3/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Vascular disorders
Pallor
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
1.4%
1/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
|
Vascular disorders
Hypertension
|
5.6%
2/36 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
0.00%
0/69 • Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
|
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-centre 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