Trial Outcomes & Findings for Phase 2 Study of GSK1363089 (Formerly XL880) in Adults With Squamous Cell Cancer of the Head and Neck (NCT NCT00725764)

Last Updated: 2017-10-16

Results Overview

Best overall response was assessed by the investigator per response evaluation criteria in solid tumors (RECIST). Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Tumor size was recorded at Baseline, and tumor response were recorded approximately every 8 weeks. Tumor response were classified by the investigator using RECIST criteria participant's best response whether observed in the study treatment period or the treatment extension period was considered. The best overall response was the best response recorded from the start of treatment until disease progression/recurrence. Number of participants who achieved best overall response were recorded.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Approximately up to 1 year

Results posted on

2017-10-16

Participant Flow

A total of 14 participants with advanced solid tumors were enrolled in this study. This study was conducted at up to 15 clinical sites in the United States.

Participant milestones

Participant milestones
Measure	Foretinib 240 mg In each treatment period, participants received foretinib 240 milligram (mg) capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of progressive disease (PD) and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
Overall Study STARTED	14
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Foretinib 240 mg In each treatment period, participants received foretinib 240 milligram (mg) capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of progressive disease (PD) and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
Overall Study Withdrawal by Subject	2
Overall Study Physician Decision	1
Overall Study Progressive Disease	7
Overall Study Lost to Follow-up	1
Overall Study Death	1
Overall Study Participant non compliant with protocol	1
Overall Study Decline in performance status	1

Baseline Characteristics

Phase 2 Study of GSK1363089 (Formerly XL880) in Adults With Squamous Cell Cancer of the Head and Neck

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Foretinib 240 mg n=14 Participants In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
Age, Continuous	59.6 Years STANDARD_DEVIATION 8.50 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized White	12 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately up to 1 year

Population: safety population comprised of all participants who passed the screening criteria, enrolled in the study, and received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Foretinib 240 mg n=14 Participants In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
Number of Participants Achieving Best Overall Response Stable Disease	7 Participants
Number of Participants Achieving Best Overall Response Progressive Disease	3 Participants
Number of Participants Achieving Best Overall Response Unable to evaluate	1 Participants

PRIMARY outcome

Timeframe: Approximately up to 1 year

Population: Safety Population.

ORR was defined as the proportion of participants achieving best overall response of confirmed CR or PR divided by the total number of participants who received treatment. Per RECIST v1.0 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; Partial Response PR, \>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR. Participants were evaluated for tumor response per RECIST. Percentage of participants with ORR were reported.

Outcome measures

Outcome measures
Measure	Foretinib 240 mg n=14 Participants In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
Percentage of Participants With Objective Response Rate (ORR)	0 Percentage of participants Interval 0.0 to 23.2

PRIMARY outcome

Timeframe: Up to 20 months

Population: Safety Population.

Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.

Outcome measures

Outcome measures
Measure	Foretinib 240 mg n=14 Participants In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs, Any event	14 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs, Any event	12 Participants

PRIMARY outcome

Timeframe: Up to 20 months

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

The National Cancer Institute -CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE and Grade 5: Death related to AE. Number of participants with abnormalities of CTCAE grade 3 in clinical chemistry parameters: alanine aminotransferase (ALT), γ-glutamyl transferase (GGT), phosphate, low sodium and hematology parameters: Leukocyte and Lymphocytes were presented.

Outcome measures

Outcome measures
Measure	Foretinib 240 mg n=14 Participants In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
Number of Participants With Abnormalities of Common Toxicity Criteria for Adverse Events (CTCAE) Grade 3 in Laboratory Parameters (Clinical Chemistry and Hematology) Hematology, Leukocyte	1 Participants
Number of Participants With Abnormalities of Common Toxicity Criteria for Adverse Events (CTCAE) Grade 3 in Laboratory Parameters (Clinical Chemistry and Hematology) Hematology, Lymphocytes	2 Participants
Number of Participants With Abnormalities of Common Toxicity Criteria for Adverse Events (CTCAE) Grade 3 in Laboratory Parameters (Clinical Chemistry and Hematology) Serum chemistry, ALT	1 Participants
Number of Participants With Abnormalities of Common Toxicity Criteria for Adverse Events (CTCAE) Grade 3 in Laboratory Parameters (Clinical Chemistry and Hematology) Serum chemistry, GGT	2 Participants
Number of Participants With Abnormalities of Common Toxicity Criteria for Adverse Events (CTCAE) Grade 3 in Laboratory Parameters (Clinical Chemistry and Hematology) Serum chemistry, phosphate	4 Participants
Number of Participants With Abnormalities of Common Toxicity Criteria for Adverse Events (CTCAE) Grade 3 in Laboratory Parameters (Clinical Chemistry and Hematology) Serum chemistry, low sodium	2 Participants

PRIMARY outcome

Timeframe: Week 5 [Day 29]

Population: Safety population.

Urinalysis parameters like appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood were performed. Number of participants with abnormalities are reported. In case of no abnormalities observed then it is reported as zero.

Outcome measures

Outcome measures
Measure	Foretinib 240 mg n=14 Participants In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
Number of Participants With Abnormalities in Urinalysis	0 Participants

SECONDARY outcome

Timeframe: Approximately up to 1 year

Population: Safety Population.

Progression-free survival was defined as the duration from the date of first dose to the date of disease progression or date of death without documented progression or date of study termination + 1. The start of confounding anticancer therapy was not treated as a censoring event. Time to progression or death was censored at the study termination date or at the analysis cutoff date, if earlier.

Outcome measures

Outcome measures
Measure	Foretinib 240 mg n=14 Participants In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
Duration of Progression-free Survival	3.65 Months Interval 0.03 to 13.86

SECONDARY outcome

Timeframe: Approximately up to 1 year

Population: Safety Population.

Overall survival was defined as the duration from the date of the first dose to the date of death. The start of a confounding anticancer therapy was treated as a censoring event. Every effort made to follow participant's until death. Time to death was censored at the date of the latest participant contact or at the analysis cutoff date, if earlier. Kaplan-Meier method was used to estimate the overall survival distribution.

Outcome measures

Outcome measures
Measure	Foretinib 240 mg n=14 Participants In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
Duration of Overall Survival	5.59 Months Interval 2.46 to 15.57

SECONDARY outcome

Timeframe: Approximately up to 1 year

Population: Safety Population. Analysis set included only participants whose best overall response was not disease progression.

Per RECIST v1.0 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; Partial Response PR, \>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR. Duration of stable disease was defined as the time between the date of first dose of study drug and the first occurrence of 1 of the events: Tumor progression per RECIST as assessed by the investigator, Termination of study drug because of disease progression, Death due to disease progression, Disease progression as documented on the participant follow-up status form, Initiation of subsequent anticancer therapy.

Outcome measures

Outcome measures
Measure	Foretinib 240 mg n=7 Participants In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
Duration of Stable Disease	4.11 Months Interval 1.81 to 13.86

SECONDARY outcome

Timeframe: Approximately up to 1 year

Population: Safety Population

Disease stabilization rate was defined as the proportion of participants for whom the best overall response was a PR, CR, or stable disease. percentage participants with disease stabilization rate were presented.

Outcome measures

Outcome measures
Measure	Foretinib 240 mg n=14 Participants In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
Percentage Participants With Disease Stabilization Rate	50.0 percentage of participants Interval 23.0 to 77.0

Adverse Events

Foretinib 240 mg

Serious events: 12 serious events

Other events: 14 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Foretinib 240 mg n=14 participants at risk In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
Gastrointestinal disorders Dysphagia	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Gastrointestinal disorders Odynophagia	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
General disorders Fatigue	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Infections and infestations Pneumonia	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Metabolism and nutrition disorders Dehydration	14.3% 2/14 • Up to 20 months Safety Population was used to collect AE and SAE
Metabolism and nutrition disorders Hyponatraemia	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Musculoskeletal and connective tissue disorders Neck pain	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Musculoskeletal and connective tissue disorders Trismus	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Vascular disorders Haemorrhage	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE

Other adverse events

Other adverse events
Measure	Foretinib 240 mg n=14 participants at risk In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
Gastrointestinal disorders Constipation	42.9% 6/14 • Up to 20 months Safety Population was used to collect AE and SAE
Gastrointestinal disorders Dysphagia	21.4% 3/14 • Up to 20 months Safety Population was used to collect AE and SAE
Gastrointestinal disorders Nausea	21.4% 3/14 • Up to 20 months Safety Population was used to collect AE and SAE
Gastrointestinal disorders Abdominal pain	14.3% 2/14 • Up to 20 months Safety Population was used to collect AE and SAE
Gastrointestinal disorders Diarrhoea	14.3% 2/14 • Up to 20 months Safety Population was used to collect AE and SAE
Gastrointestinal disorders Dyspepsia	14.3% 2/14 • Up to 20 months Safety Population was used to collect AE and SAE
Gastrointestinal disorders Abdominal pain upper	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Gastrointestinal disorders Dry mouth	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Gastrointestinal disorders Gingival pain	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Gastrointestinal disorders Glossodynia	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Gastrointestinal disorders Haematochezia	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Gastrointestinal disorders Odynophagia	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Gastrointestinal disorders Oral discomfort	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Gastrointestinal disorders Oral pain	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Gastrointestinal disorders Stomach discomfort	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Gastrointestinal disorders Stomatitis	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Gastrointestinal disorders Swollen tongue	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Gastrointestinal disorders Tongue disorder	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
General disorders Fatigue	50.0% 7/14 • Up to 20 months Safety Population was used to collect AE and SAE
General disorders Mucosal inflammation	28.6% 4/14 • Up to 20 months Safety Population was used to collect AE and SAE
General disorders Pain	14.3% 2/14 • Up to 20 months Safety Population was used to collect AE and SAE
General disorders Pyrexia	14.3% 2/14 • Up to 20 months Safety Population was used to collect AE and SAE
General disorders Asthenia	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
General disorders Chills	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
General disorders Facial pain	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
General disorders Local swelling	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
General disorders Temperature intolerance	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Investigations Alanine aminotransferase increased	28.6% 4/14 • Up to 20 months Safety Population was used to collect AE and SAE
Investigations Aspartate aminotransferase increased	28.6% 4/14 • Up to 20 months Safety Population was used to collect AE and SAE
Investigations Weight decreased	28.6% 4/14 • Up to 20 months Safety Population was used to collect AE and SAE
Investigations Blood lactate dehydrogenase increased	14.3% 2/14 • Up to 20 months Safety Population was used to collect AE and SAE
Investigations Blood alkaline phosphatase increased	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Investigations Blood calcium decreased	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Investigations Heart rate increased	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Investigations Heart sounds abnormal	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Investigations International normalised ratio increased	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Investigations Prothrombin time prolonged	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Musculoskeletal and connective tissue disorders Musculoskeletal pain	21.4% 3/14 • Up to 20 months Safety Population was used to collect AE and SAE
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 2/14 • Up to 20 months Safety Population was used to collect AE and SAE
Musculoskeletal and connective tissue disorders Back pain	14.3% 2/14 • Up to 20 months Safety Population was used to collect AE and SAE
Musculoskeletal and connective tissue disorders Neck pain	14.3% 2/14 • Up to 20 months Safety Population was used to collect AE and SAE
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 2/14 • Up to 20 months Safety Population was used to collect AE and SAE
Musculoskeletal and connective tissue disorders Bone pain	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Musculoskeletal and connective tissue disorders Flank pain	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Musculoskeletal and connective tissue disorders Myalgia	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Musculoskeletal and connective tissue disorders Neck mass	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Musculoskeletal and connective tissue disorders Pain in jaw	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Musculoskeletal and connective tissue disorders Soft tissue necrosis	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Musculoskeletal and connective tissue disorders Trismus	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Skin and subcutaneous tissue disorders Dry skin	21.4% 3/14 • Up to 20 months Safety Population was used to collect AE and SAE
Skin and subcutaneous tissue disorders Rash	21.4% 3/14 • Up to 20 months Safety Population was used to collect AE and SAE
Skin and subcutaneous tissue disorders Alopecia	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Skin and subcutaneous tissue disorders Blister	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Skin and subcutaneous tissue disorders Dermatitis contact	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Skin and subcutaneous tissue disorders Erythema	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Skin and subcutaneous tissue disorders Hyperhidrosis	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Skin and subcutaneous tissue disorders Pain of skin	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Skin and subcutaneous tissue disorders Rash generalised	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Skin and subcutaneous tissue disorders Rash maculo-papular	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Skin and subcutaneous tissue disorders Skin reaction	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Skin and subcutaneous tissue disorders Telangiectasia	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Nervous system disorders Headache	28.6% 4/14 • Up to 20 months Safety Population was used to collect AE and SAE
Nervous system disorders Dizziness	21.4% 3/14 • Up to 20 months Safety Population was used to collect AE and SAE
Nervous system disorders Neuropathy peripheral	14.3% 2/14 • Up to 20 months Safety Population was used to collect AE and SAE
Nervous system disorders Amnesia	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Nervous system disorders Dysgeusia	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Nervous system disorders Memory impairment	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Respiratory, thoracic and mediastinal disorders Dyspnoea	28.6% 4/14 • Up to 20 months Safety Population was used to collect AE and SAE
Respiratory, thoracic and mediastinal disorders Dysphonia	14.3% 2/14 • Up to 20 months Safety Population was used to collect AE and SAE
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	14.3% 2/14 • Up to 20 months Safety Population was used to collect AE and SAE
Respiratory, thoracic and mediastinal disorders Bronchial secretion retention	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Respiratory, thoracic and mediastinal disorders Cough	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Respiratory, thoracic and mediastinal disorders Dyspnoea paroxysmal nocturnal	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Respiratory, thoracic and mediastinal disorders Haemoptysis	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Respiratory, thoracic and mediastinal disorders Painful respiration	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Respiratory, thoracic and mediastinal disorders Productive cough	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Respiratory, thoracic and mediastinal disorders Sinus congestion	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Infections and infestations Candidiasis	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Infections and infestations Herpes zoster	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Infections and infestations Localised infection	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Infections and infestations Oral candidiasis	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Infections and infestations Otitis media	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Infections and infestations Pharyngitis	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Infections and infestations Postoperative wound infection	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Infections and infestations Tooth abscess	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Infections and infestations Upper respiratory tract infection	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Metabolism and nutrition disorders Anorexia	28.6% 4/14 • Up to 20 months Safety Population was used to collect AE and SAE
Metabolism and nutrition disorders Hypophosphataemia	21.4% 3/14 • Up to 20 months Safety Population was used to collect AE and SAE
Metabolism and nutrition disorders Decreased appetite	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Metabolism and nutrition disorders Dehydration	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Metabolism and nutrition disorders Hypomagnesaemia	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Metabolism and nutrition disorders Hyponatraemia	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Psychiatric disorders Depression	21.4% 3/14 • Up to 20 months Safety Population was used to collect AE and SAE
Psychiatric disorders Insomnia	21.4% 3/14 • Up to 20 months Safety Population was used to collect AE and SAE
Psychiatric disorders Panic attack	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Vascular disorders Hypertension	35.7% 5/14 • Up to 20 months Safety Population was used to collect AE and SAE
Blood and lymphatic system disorders Anaemia	14.3% 2/14 • Up to 20 months Safety Population was used to collect AE and SAE
Blood and lymphatic system disorders Leukopenia	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Blood and lymphatic system disorders Neutropenia	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Ear and labyrinth disorders Ear pain	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Ear and labyrinth disorders Hypoacusis	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Injury, poisoning and procedural complications Procedural site reaction	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Injury, poisoning and procedural complications Wound secretion	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Renal and urinary disorders Dysuria	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Renal and urinary disorders Haematuria	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Cardiac disorders Tachycardia	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE
Endocrine disorders Hypothyroidism	7.1% 1/14 • Up to 20 months Safety Population was used to collect AE and SAE

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