Trial Outcomes & Findings for GW572016 In Patients With ErbB2 Over - Expressing Advanced Or Metastatic Breast Cancer (NCT NCT00320411)

NCT ID: NCT00320411

Last Updated: 2019-01-31

Results Overview

Tumor response was measured as the number of participants achieving either a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) among all participants who received study treatment. Tumor response was evaluated as the best response in accordance with response evaluation criteria in solid tumors (RECIST). Progressive disease: a 20% increase in the sum of the longest diameter of target lesions. Stable disease: small changes that do not meet the above-mentioned criteria.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 62 participants
• Primary outcome timeframe: Baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.
• Results posted on: 2019-01-31

Participant Flow

Participant milestones

Measure	Lapatinib Monotherapy Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Study STARTED	62
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Lapatinib Monotherapy Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Study No investigational product admin.	4

Baseline Characteristics

GW572016 In Patients With ErbB2 Over - Expressing Advanced Or Metastatic Breast Cancer

Baseline characteristics by cohort

Measure	Lapatinib Monotherapy n=58 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Age, Continuous	54.6 years STANDARD_DEVIATION 8.52 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	58 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.

Population: Intent-to-Treat (ITT) Population: all participants who had been registered and received at least one dose of the investigational product

Tumor response was measured as the number of participants achieving either a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) among all participants who received study treatment. Tumor response was evaluated as the best response in accordance with response evaluation criteria in solid tumors (RECIST). Progressive disease: a 20% increase in the sum of the longest diameter of target lesions. Stable disease: small changes that do not meet the above-mentioned criteria.

Outcome measures

Measure	Lapatinib Monotherapy n=58 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Tumor Response Partial response	8 participants
Overall Tumor Response Stable disease	18 participants
Overall Tumor Response Progressive disease	29 participants
Overall Tumor Response Unknown	2 participants
Overall Tumor Response Complete response	1 participants

SECONDARY outcome

Timeframe: First noted efficacy to disease progression; baseline and followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.

Population: Participants who achieved defined efficacy

Duration of response is defined as the time between the point at which efficacy was noted until disease progression or death due to breast cancer.

Outcome measures

Measure	Lapatinib Monotherapy n=9 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Duration of Response	20.6 weeks Interval 16.1 to 32.1

SECONDARY outcome

Timeframe: Baseline to disease progression or death; baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression or death.

Population: ITT Population

Time to progression was defined as the time from the start of treatment until disease progression or death. Disease progression is defined as a 20% increase in the sum of the longest diameter of target lesions.

Outcome measures

Measure	Lapatinib Monotherapy n=58 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Time to Progression	8.4 weeks Interval 7.4 to 23.9

SECONDARY outcome

Timeframe: Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse events, then followed every 12 weeks until DP or death.

Population: ITT Population

Clinical benefit was defined as the percentage of participants achieving complete response, partial response, and stable disease for more than 24 weeks.

Outcome measures

Measure	Lapatinib Monotherapy n=58 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Clinical Benefit	17.2 percentage of participants

SECONDARY outcome

Timeframe: Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse event, then followed every 12 weeks until DP or death.

Population: Participants in the ITT Population achieving a partial or complete response

Time to response was defined as the time from the start of treatment until first documented evidence of partial or complete tumor response (whichever status is recorded first).

Outcome measures

Measure	Lapatinib Monotherapy n=9 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Time to Response	111 Days Interval 56.0 to 279.0

SECONDARY outcome

Timeframe: Baseline to Month 4 (Week 16)

Population: ITT Population

The percentage of participants without progression or deaths at 4 months (16 weeks) after the start of dosing.

Outcome measures

Measure	Lapatinib Monotherapy n=58 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
4-month Progression Free Survival	32.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Month 6 (Week 24)

Population: ITT Population

The percentage of participants without progression or deaths at 6 months (24 weeks) after the start of dosing.

Outcome measures

Measure	Lapatinib Monotherapy n=58 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
6-month Progression Free Survival	22.8 percentage of participants

SECONDARY outcome

Timeframe: Start of dosing to death; baseline and then followed every 4 weeks until death while on treatment. If alive at time of treatment termination, then followed every 12 weeks until death.

Population: ITT Population

Overall survival was measured as the time between the start of dosing until death, regardless of cause.

Outcome measures

Measure	Lapatinib Monotherapy n=58 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Overall Survival	43.1 weeks Interval 24.3 to 80.7

SECONDARY outcome

Timeframe: Tumor samples taken at baseline

Population: Participants who provided enough tumor samples for this evaluation.

Intra-tumoral expression levels of AKT, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.

Outcome measures

Measure	Lapatinib Monotherapy n=10 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Mean Phosphorylated 58 kDa Serine/Threonine Protein Kinase (p-AKT) H Score for All Participants	13.9 units on a scale Standard Deviation 26.32

SECONDARY outcome

Timeframe: Tumor samples taken at baseline

Population: Participants who provided enough tumor samples for this evaluation

Intra-tumoral expression levels of BAD, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.

Outcome measures

Measure	Lapatinib Monotherapy n=9 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Mean p-BAD H Score for All Participants	12.8 units on a scale Standard Deviation 36.50

SECONDARY outcome

Timeframe: Tumor samples taken at baseline

Population: Participants who provided enough tumor samples for this evaluation

Intra-tumoral expression levels of Bcl-2, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.

Outcome measures

Measure	Lapatinib Monotherapy n=18 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Mean Bcl-2 H Score for All Participants	20.9 units on a scale Standard Deviation 47.82

SECONDARY outcome

Timeframe: Tumor samples taken at baseline

Population: Participants who provided enough tumor samples for this evaluation

Intra-tumoral expression levels of ErbB3, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.

Outcome measures

Measure	Lapatinib Monotherapy n=23 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Mean Epidermal Growth Factor Receptor 3 (ErbB3) H Score for All Participants	185.5 units on a scale Standard Deviation 50.61

SECONDARY outcome

Timeframe: Tumor samples taken at baseline

Population: Participants who provided enough tumor samples for this evaluation

Intra-tumoral expression levels of ErbB4, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.

Outcome measures

Measure	Lapatinib Monotherapy n=9 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Mean Epidermal Growth Factor Receptor 4 (ErbB4) H Score for All Participants	133.3 units on a scale Standard Deviation 60.47

SECONDARY outcome

Timeframe: Tumor samples taken at baseline

Population: Participants who provided enough tumor samples for this evaluation

Intra-tumoral expression levels of ERK, a tumor tissue biomarker, were measured.using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.

Outcome measures

Measure	Lapatinib Monotherapy n=9 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Mean Phosphorylated Extracellular Signal-regulated Kinase (p-ERK) H Score for All Participants	12.2 units on a scale Standard Deviation 17.30

SECONDARY outcome

Timeframe: Tumor samples taken at baseline

Population: Participants who provided enough tumor samples for this evaluation

Intra-tumoral expression levels of Heregulin, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.

Outcome measures

Measure	Lapatinib Monotherapy n=18 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Mean Heregulin H Score for All Participants	55.3 units on a scale Standard Deviation 42.37

SECONDARY outcome

Timeframe: Tumor samples taken at baseline

Population: Participants who provided enough tumor samples for this evaluation

Intra-tumoral expression levels of IGF1R, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.

Outcome measures

Measure	Lapatinib Monotherapy n=23 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Mean Insulin-like Growth Factor 1 Receptor (IGF1R) H Score for All Participants	153.5 units on a scale Standard Deviation 48.44

SECONDARY outcome

Timeframe: Tumor samples taken at baseline

Population: Participants who provided enough tumor samples for this evaluation

Intra-tumoral expression levels of Survivin, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.

Outcome measures

Measure	Lapatinib Monotherapy n=10 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Mean Survivin H Score for All Participants	79.0 units on a scale Standard Deviation 47.25

SECONDARY outcome

Timeframe: Tumor samples taken at baseline

Population: Participants who provided enough tumor samples for this evaluation

Intra-tumoral expression levels of TUNEL, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.

Outcome measures

Measure	Lapatinib Monotherapy n=10 Participants Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Mean Terminal Deoxynucleotidyl Transferase Biotin-dUTP Nick End Labeling (TUNEL) H Score for All Participants	48.9 units on a scale Standard Deviation 26.88

Adverse Events

Lapatinib Monotherapy

Serious events: 14 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lapatinib Monotherapy n=58 participants at risk Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Metabolism and nutrition disorders Anorexia	5.2% 3/58
Metabolism and nutrition disorders Hypercalcemia	1.7% 1/58
Infections and infestations Pneumonia	3.4% 2/58
Infections and infestations Cellulitis	1.7% 1/58
Hepatobiliary disorders Hepatic function abnormal	3.4% 2/58
Hepatobiliary disorders Hepatomegaly	1.7% 1/58
General disorders Malaise	1.7% 1/58
General disorders Disease progression	1.7% 1/58
Investigations Lymphocyte count decreased	1.7% 1/58
Investigations Blood uric acid increased	1.7% 1/58
Gastrointestinal disorders Nausea	1.7% 1/58
Gastrointestinal disorders Diarrhea	1.7% 1/58
Gastrointestinal disorders Vomiting	1.7% 1/58
Musculoskeletal and connective tissue disorders Back pain	1.7% 1/58
Cardiac disorders Ventricular dysfunction	1.7% 1/58
Nervous system disorders Dizziness	1.7% 1/58
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	1.7% 1/58

Other adverse events

Measure	Lapatinib Monotherapy n=58 participants at risk Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
Gastrointestinal disorders Dyspepsia	3.4% 2/58
Gastrointestinal disorders Ascites	3.4% 2/58
Gastrointestinal disorders Flatulence	1.7% 1/58
Gastrointestinal disorders Cheilitis	1.7% 1/58
Gastrointestinal disorders Hemorrhoidal hemorrhage	1.7% 1/58
Gastrointestinal disorders Epigastric discomfort	1.7% 1/58
Gastrointestinal disorders Glossitis	1.7% 1/58
Gastrointestinal disorders Abdominal distension	1.7% 1/58
Gastrointestinal disorders Proctalgia	1.7% 1/58
Gastrointestinal disorders Umbilical hernia	1.7% 1/58
Skin and subcutaneous tissue disorders Rash	39.7% 23/58
Skin and subcutaneous tissue disorders Pruritus	22.4% 13/58
Skin and subcutaneous tissue disorders Acne	20.7% 12/58
Skin and subcutaneous tissue disorders Dry skin	15.5% 9/58
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	12.1% 7/58
Skin and subcutaneous tissue disorders Exfoliative rash	8.6% 5/58
Skin and subcutaneous tissue disorders Comedone	8.6% 5/58
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	6.9% 4/58
Skin and subcutaneous tissue disorders Nail disorder	6.9% 4/58
Skin and subcutaneous tissue disorders Ingrowing nail	6.9% 4/58
Skin and subcutaneous tissue disorders Eczema	3.4% 2/58
Skin and subcutaneous tissue disorders Erythema multiforme	3.4% 2/58
Skin and subcutaneous tissue disorders Skin exfoliation	3.4% 2/58
Skin and subcutaneous tissue disorders Skin chapped	1.7% 1/58
Skin and subcutaneous tissue disorders Erythema	1.7% 1/58
Skin and subcutaneous tissue disorders Rash erythematous	1.7% 1/58
Skin and subcutaneous tissue disorders Pigmentation disorder	1.7% 1/58
Skin and subcutaneous tissue disorders Dermatitis contact	1.7% 1/58
Skin and subcutaneous tissue disorders Generalized erythema	1.7% 1/58
Skin and subcutaneous tissue disorders Toxic skin eruption	1.7% 1/58
Skin and subcutaneous tissue disorders Asteatotic eczema	1.7% 1/58
Skin and subcutaneous tissue disorders Hair disorder	1.7% 1/58
Skin and subcutaneous tissue disorders Urticaria	1.7% 1/58
Skin and subcutaneous tissue disorders Decubitus ulcer	1.7% 1/58
Infections and infestations Nasopharyngitis	22.4% 13/58
Infections and infestations Paronychia	6.9% 4/58
Infections and infestations Pneumonia	1.7% 1/58
Infections and infestations Rhinitis	5.2% 3/58
Infections and infestations Cellulitis	3.4% 2/58
Infections and infestations Cystitis	5.2% 3/58
Infections and infestations Pharyngitis	3.4% 2/58
Infections and infestations Influenza	1.7% 1/58
Infections and infestations Gastroenteritis	1.7% 1/58
Infections and infestations Otitis externa	1.7% 1/58
Infections and infestations Eye lid infection	1.7% 1/58
Infections and infestations Localized infection	1.7% 1/58
Infections and infestations Abscess limb	1.7% 1/58
Infections and infestations Tinea pedis	1.7% 1/58
Infections and infestations Herpes zoster	1.7% 1/58
Infections and infestations Urinary tract infection	1.7% 1/58
Infections and infestations Hordeolum	1.7% 1/58
Gastrointestinal disorders Diarrhea	62.1% 36/58
Gastrointestinal disorders Stomatitis	46.6% 27/58
Gastrointestinal disorders Nausea	37.9% 22/58
Gastrointestinal disorders Vomiting	20.7% 12/58
Gastrointestinal disorders Constipation	19.0% 11/58
Gastrointestinal disorders Abdominal pain upper	10.3% 6/58
Gastrointestinal disorders Abdominal pain	6.9% 4/58
Gastrointestinal disorders Dry mouth	5.2% 3/58
Gastrointestinal disorders Hemorrhoids	5.2% 3/58
Gastrointestinal disorders Gastritis	3.4% 2/58
Gastrointestinal disorders Gastric ulcer	3.4% 2/58
Gastrointestinal disorders Stomach discomfort	3.4% 2/58
Infections and infestations Skin infection	1.7% 1/58
Infections and infestations Chronic sinusitis	1.7% 1/58
Infections and infestations Omphalitis	1.7% 1/58
General disorders Fatigue	39.7% 23/58
General disorders Pyrexia	19.0% 11/58
General disorders Chest pain	8.6% 5/58
General disorders Malaise	6.9% 4/58
General disorders Edema	5.2% 3/58
General disorders Edema peripheral	5.2% 3/58
General disorders Pain	5.2% 3/58
General disorders Chest discomfort	1.7% 1/58
General disorders Ulcer	1.7% 1/58
General disorders Asthenia	1.7% 1/58
Investigations Weight decreased	24.1% 14/58
Investigations Alanine aminotransferase increased	22.4% 13/58
Investigations Aspartate aminotransferase increased	20.7% 12/58
Investigations Blood alkaline phosphatase increased	15.5% 9/58
Investigations Blood bilirubin increased	12.1% 7/58
Investigations Hemoglobin decreased	6.9% 4/58
Investigations Neutrophil count decreased	6.9% 4/58
Investigations Blood urine present	6.9% 4/58
Investigations Blood uric acid increased	3.4% 2/58
Investigations White blood cell count decreased	5.2% 3/58
Investigations Lymphocyte count decreased	1.7% 1/58
Investigations Eosinophil count decreased	3.4% 2/58
Investigations Neutrophil count increased	3.4% 2/58
Investigations White blood cell count increased	3.4% 2/58
Investigations Protein urine	3.4% 2/58
Investigations Blood urea increased	3.4% 2/58
Investigations Hematocrit decreased	1.7% 1/58
Investigations Gamma-glutamyltransferase increased	1.7% 1/58
Investigations Ejection fraction decreased	1.7% 1/58
Investigations Platelet count decreased	1.7% 1/58
Investigations Platelet count increased	1.7% 1/58
Investigations Blood albumin decreased	1.7% 1/58
Investigations Blood creatinine increased	1.7% 1/58
Investigations Blood triglycerides increased	1.7% 1/58
Investigations Blood sodium decreased	1.7% 1/58
Investigations Blood glucose decreased	1.7% 1/58
Investigations Blood iron decreased	1.7% 1/58
Investigations Blood urea decreased	1.7% 1/58
Investigations Red blood cell count decreased	1.7% 1/58
Investigations Protein total decreased	1.7% 1/58
Investigations Weight increased	1.7% 1/58
Investigations Monocyte count increased	1.7% 1/58
Investigations Specific gravity urine	1.7% 1/58
Respiratory, thoracic and mediastinal disorders Cough	15.5% 9/58
Respiratory, thoracic and mediastinal disorders Epistaxis	12.1% 7/58
Respiratory, thoracic and mediastinal disorders Nasal dryness	8.6% 5/58
Respiratory, thoracic and mediastinal disorders Dyspnea	6.9% 4/58
Respiratory, thoracic and mediastinal disorders Productive cough	5.2% 3/58
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	3.4% 2/58
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	3.4% 2/58
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.7% 1/58
Respiratory, thoracic and mediastinal disorders Postnasal drip	1.7% 1/58
Respiratory, thoracic and mediastinal disorders Dysphonia	1.7% 1/58
Respiratory, thoracic and mediastinal disorders Rhinorrhea	1.7% 1/58
Metabolism and nutrition disorders Anorexia	34.5% 20/58
Metabolism and nutrition disorders Hypercalcemia	1.7% 1/58
Metabolism and nutrition disorders Hyperkalemia	1.7% 1/58
Metabolism and nutrition disorders Hyperglycemia	1.7% 1/58
Metabolism and nutrition disorders Hyperuricemia	1.7% 1/58
Musculoskeletal and connective tissue disorders Back pain	17.2% 10/58
Musculoskeletal and connective tissue disorders Shoulder pain	5.2% 3/58
Musculoskeletal and connective tissue disorders Arthralgia	3.4% 2/58
Musculoskeletal and connective tissue disorders Periarthritis	1.7% 1/58
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.7% 1/58
Musculoskeletal and connective tissue disorders Myalgia	1.7% 1/58
Musculoskeletal and connective tissue disorders Muscular weakness	1.7% 1/58
Musculoskeletal and connective tissue disorders Muscle spasms	1.7% 1/58
Musculoskeletal and connective tissue disorders Neck pain	1.7% 1/58
Musculoskeletal and connective tissue disorders Flank pain	1.7% 1/58
Nervous system disorders Headache	12.1% 7/58
Nervous system disorders Dysgeusia	6.9% 4/58
Nervous system disorders Dizziness	3.4% 2/58
Nervous system disorders Hypoesthesia	3.4% 2/58
Nervous system disorders Somnolence	3.4% 2/58
Nervous system disorders Hepatic encephalopathy	1.7% 1/58
Psychiatric disorders Insomnia	19.0% 11/58
Psychiatric disorders Mood altered	1.7% 1/58
Psychiatric disorders Anxiety disorder	1.7% 1/58
Renal and urinary disorders Dysuria	3.4% 2/58
Renal and urinary disorders Pollakiuria	3.4% 2/58
Renal and urinary disorders Proteinuria	1.7% 1/58
Renal and urinary disorders Urinary incontinence	1.7% 1/58
Renal and urinary disorders Urinary retention	1.7% 1/58
Renal and urinary disorders Cystitis-like symptom	1.7% 1/58
Eye disorders Abnormal sensation in eye	1.7% 1/58
Eye disorders Dry eye	1.7% 1/58
Eye disorders Eyelid edema	1.7% 1/58
Eye disorders Blepharospasm	1.7% 1/58
Eye disorders Scleral hemorrhage	1.7% 1/58
Eye disorders Conjunctivitis	1.7% 1/58
Eye disorders Conjunctival hyperemia	1.7% 1/58
Eye disorders Diplopia	1.7% 1/58
Eye disorders Vision blurred	1.7% 1/58
Blood and lymphatic system disorders Anemia	6.9% 4/58
Blood and lymphatic system disorders Lymph node pain	1.7% 1/58
Blood and lymphatic system disorders Iron deficiency anemia	1.7% 1/58
Blood and lymphatic system disorders Leukopenia	1.7% 1/58
Vascular disorders Flushing	6.9% 4/58
Vascular disorders Hot flush	3.4% 2/58
Vascular disorders Vasodilatation	1.7% 1/58
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	6.9% 4/58
Hepatobiliary disorders Hepatic pain	1.7% 1/58
Hepatobiliary disorders Hyperbilirubinemia	1.7% 1/58
Injury, poisoning and procedural complications Nail avulsion	1.7% 1/58
Injury, poisoning and procedural complications Thermal burn	1.7% 1/58
Injury, poisoning and procedural complications Skin laceration	1.7% 1/58
Injury, poisoning and procedural complications Brachial plexus injury	1.7% 1/58
Immune system disorders Seasonal allergy	3.4% 2/58
Injury, poisoning and procedural complications Hypersensitivity	1.7% 1/58
Cardiac disorders Supraventricular extrasystoles	1.7% 1/58
Cardiac disorders Ventricular extrasystoles	1.7% 1/58
Reproductive system and breast disorders Genital hemorrhage	1.7% 1/58
Reproductive system and breast disorders Breast pain	1.7% 1/58
Reproductive system and breast disorders Breast discharge	1.7% 1/58
Ear and labyrinth disorders Vertigo	1.7% 1/58
Ear and labyrinth disorders Motion sickness	1.7% 1/58

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER