A Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01196078
• Collaborator: (none)
• Enrollment: 114
• Location: 1
• Arms: 2
• Duration (Months): 46
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

This study will compare the efficacy and safety of Tarceva (erlotinib) and vinorelbine in chemo-naive elderly patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1 and 8 of cycle 1 and 80 mg/m2 for the other 21 days cycles). The anticipated time on study treatment is until disease progression.

Condition or Disease	Intervention/Treatment	Phase
Non-Small Cell Lung Cancer	Drug: erlotinib [Tarceva]; Drug: vinorelbine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Randomized Trial of Erlotinib or Vinorelbine in Chemo-naive, Advanced, Non-Small-Cell Lung Cancer Patients Aged 70 Years or Older in Taiwan
• Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: erlotinib [Tarceva]; 150 mg, orally once a day for up to 6 cycles of 21 days each
Active Comparator: 2	Drug: vinorelbine; 60 mg/m2, orally on days 1 and 8 of cycle 1, 80 mg/m2 for the other cycles

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year]

   CR was defined as disappearance of all target lesions. PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Participants experiencing either a CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) were classified as responders. Participants with tumour assessment unevaluable were viewed as non-responders.

Secondary Outcome Measures

1. Percentage of Participants Achieving Disease Control [Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year]

   Disease control was defined as achieving a best overall response of CR, PR, or stable disease (SD) according to RECIST criteria. Participants with tumor assessment unevaluable were viewed as uncontrolled.

2. Duration of Response Among Participants Who Achieved Either a CR or PR [Screening, Day 1 of Cycles 3 and 5, every 4th cycle during post-study treatment, and every 3 cycles during follow-up]

   Duration of response was defined similarly for complete and partial responders. Complete response lasted from the date the complete response was first recorded to the date on which progressive disease was first noted or date of death. Partial response lasted from the date of partial response to the date of the first observation of progressive disease or date of death.

3. Percentage of Participants With Disease Progression [Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death]

   Progressive disease was defined using RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

4. Time to Disease Progression [Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death]

   Time to disease progression was defined as the interval between the day of randomization and the first documentation of progressive disease or death.

5. Overall Survival: Percentage of Participants With an Progressive Disease or Death [Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment]

   Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no postbaseline information were censored at the time of randomization. Progressive disease was defined per RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

6. Overall Survival: Time to Event [Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment]

   Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no post baseline information were censored at the time of randomization. Overall median time to event was assessed for the population that experienced an event.

7. Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT) Questionnaire [Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study]

   The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including Physical Well-Being (PWB), Social/family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and the 8-item Lung Cancer Subscale (LCS) that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The FACT-L score ranges from 0 to 136, with higher scores indicating better quality of life.

8. Changes in Quality of Life as Measured by the FACT Questionnaire [Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study]

   The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, response of down, up or no change were defined as score changes of less than or equal to (≤)2, greater than or equal to (≥)+2, or between these values.

9. Percentage of Participants With Changes in Quality of Life as Measured by FACT Questionnaire Scores by Category of Change [Baseline and End of study]

   The FACT and the FACT-L contain 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented Worsened'. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, higher scores indicated a better outcome; a response of down, up, or no change was defined as a score change of ≤ -2 (score down), ≥ +2 (score up), or between these values.

10. Changes in Quality of Life as Assessed by FACT-L (Lung Symptoms) Questionnaire [Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study]

    The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition) rated on a five-point scale from 0 (not at all) to 4 (very much). The LCS total score is the sum of the scores from the 7 items. For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The change of FACT-L subscore was the change from baseline to endpoint. The LCS of FACT-L is an independently validated tool that measures the disease-related symptoms of lung cancer on an overall scale of 0 (most symptomatic) to 28 (asymptomatic).

11. Percentage of Participants With Changes in FACT-L (Lung Symptoms) by Category of Change [Baseline and End of study]

    The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items, each rated on a five-point scale from 0 (not at all) to 4 (very much). For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. For each FACT-L question, the response status was defined as down, up, or no change if the score at endpoint was smaller (score down), larger than (score up), or the same as (no change) that at baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult patients, >=70 years of age

• Non-small cell lung cancer

• Naive to prior chemotherapy or specific immunotherapy

• Presence of at least 1 measurable lesion

Exclusion Criteria:

• Active non-controlled infection or disease

• CNS metastases

• Any other malignancies (other than adequately treated basal cell cancer of skin, or in situ cancer of the cervix)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Taipei		Taiwan

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Chair: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01196078
• Other Study ID Numbers: ML20322
• First Posted: Sep 8, 2010
• Last Update Posted: Jul 27, 2015
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Erlotinib Hydrochloride; Vinorelbine

Study Results

Participant Flow

Arm/Group Title	Erlotinib	Vinorelbine
Arm/Group Description	Participants received erlotinib 150 milligrams (mg), tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.	Cycle 1 (21-day cycle): Participants received vinorelbine 60 milligrams per square meter (mg/m^2) orally on Days 1 and 8, followed by 1 week off. Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 adverse events [AEs]) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.
Period Title: Overall Study
STARTED	57	57
COMPLETED	24	20
NOT COMPLETED	33	37

Baseline Characteristics

Arm/Group Title	Erlotinib	Vinorelbine	Total
Arm/Group Description	Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.	Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off. Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.	Total of all reporting groups
Overall Participants	57	56	113
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	78 (4.98)	78 (5.32)	78 (5.60)
Sex: Female, Male (Count of Participants)
Female	10 17.5%	11 19.6%	21 18.6%
Male	47 82.5%	45 80.4%	92 81.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)
Description	CR was defined as disappearance of all target lesions. PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Participants experiencing either a CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) were classified as responders. Participants with tumour assessment unevaluable were viewed as non-responders.
Time Frame	Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Erlotinib	Vinorelbine
Arm/Group Description	Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.	Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off. Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.
Measure Participants	57	56
Number [percentage of participants]	22.81 40%	8.93 15.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Erlotinib, Vinorelbine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0388
	Comments	Between-treatment difference computed using logistic regression with treatment and multiple factors (gender, Eastern Cooperative Oncology Group [ECOG] status, histology status, and smoking status) as explanatory variables.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentages
	Estimated Value	13.88
	Confidence Interval	(2-Sided) 95%; -0.22 to 26.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% confidence interval (CI) for the difference in tumor response rate determined using Hauck-Anderson approach.

2. Secondary Outcome

Title	Percentage of Participants Achieving Disease Control
Description	Disease control was defined as achieving a best overall response of CR, PR, or stable disease (SD) according to RECIST criteria. Participants with tumor assessment unevaluable were viewed as uncontrolled.
Time Frame	Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Erlotinib	Vinorelbine
Arm/Group Description	Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.	Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off. Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.
Measure Participants	57	56
Number [percentage of participants]	71.93 126.2%	57.14 102%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Erlotinib, Vinorelbine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1061
	Comments	Between-treatment difference computed using logistic regression with treatment and multiple factors (gender, ECOG status, histology status, and smoking status) as explanatory variables.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentages
	Estimated Value	14.79
	Confidence Interval	(2-Sided) 95%; -3.54 to 31.33
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for the difference in the disease control rate determined using Hauck-Anderson approach.

3. Secondary Outcome

Title	Duration of Response Among Participants Who Achieved Either a CR or PR
Description	Duration of response was defined similarly for complete and partial responders. Complete response lasted from the date the complete response was first recorded to the date on which progressive disease was first noted or date of death. Partial response lasted from the date of partial response to the date of the first observation of progressive disease or date of death.
Time Frame	Screening, Day 1 of Cycles 3 and 5, every 4th cycle during post-study treatment, and every 3 cycles during follow-up

Outcome Measure Data

Analysis Population Description

ITT population; only participants with a response (CR or PR) were included in the analysis.

Arm/Group Title	Erlotinib	Vinorelbine
Arm/Group Description	Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.	Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off. Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.
Measure Participants	13	5
Median (95% Confidence Interval) [months]	10.89	8.75

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Erlotinib, Vinorelbine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9505
	Comments
	Method	Log Rank
	Comments

4. Secondary Outcome

Title	Percentage of Participants With Disease Progression
Description	Progressive disease was defined using RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame	Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Erlotinib	Vinorelbine
Arm/Group Description	Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.	Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off. Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.
Measure Participants	57	56
Number [percentage of participants]	63.16 110.8%	58.93 105.2%

5. Secondary Outcome

Title	Time to Disease Progression
Description	Time to disease progression was defined as the interval between the day of randomization and the first documentation of progressive disease or death.
Time Frame	Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Erlotinib	Vinorelbine
Arm/Group Description	Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.	Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off. Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.
Measure Participants	57	56
Median (95% Confidence Interval) [months]	6.66	3.87

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Erlotinib, Vinorelbine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2314
	Comments
	Method	Log Rank
	Comments	Data were stratified by gender, ECOG status, histology status, and smoking status.

6. Secondary Outcome

Title	Overall Survival: Percentage of Participants With an Progressive Disease or Death
Description	Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no postbaseline information were censored at the time of randomization. Progressive disease was defined per RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame	Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Erlotinib	Vinorelbine
Arm/Group Description	Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.	Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off. Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.
Measure Participants	57	56
Number [percentage of participants]	56.14 98.5%	48.21 86.1%

7. Secondary Outcome

Title	Overall Survival: Time to Event
Description	Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no post baseline information were censored at the time of randomization. Overall median time to event was assessed for the population that experienced an event.
Time Frame	Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Erlotinib	Vinorelbine
Arm/Group Description	Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.	Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off. Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.
Measure Participants	57	56
Median (95% Confidence Interval) [months]	11.21	10.36

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Erlotinib, Vinorelbine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9894
	Comments
	Method	Log Rank
	Comments	Data were stratified by gender, ECOG status, histology status, and smoking status.

8. Secondary Outcome

Title	Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT) Questionnaire
Description	The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including Physical Well-Being (PWB), Social/family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and the 8-item Lung Cancer Subscale (LCS) that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The FACT-L score ranges from 0 to 136, with higher scores indicating better quality of life.
Time Frame	Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study

Outcome Measure Data

Analysis Population Description

Safety Population; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Erlotinib	Vinorelbine
Arm/Group Description	Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.	Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off. Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.
Measure Participants	57	55
PWB, Baseline (n=56,53)	6.8 (4.0)	6.2 (3.7)
PWB, Cycle 2 (n=52,42)	8.1 (3.7)	7.5 (4.4)
PWB, Cycle 3 (n=41,28)	8.9 (4.3)	5.7 (4.2)
PWB, Cycle 4 (n=37,28)	9.4 (4.0)	7.8 (6.1)
PWB, Cycle 5 (n=30,22)	8.8 (4.3)	7.7 (5.5)
PWB, Cycle 6 (n=25,20)	9.3 (5.0)	6.4 (5.5)
PWB, End of Study (n=52,48)	10.8 (5.2)	7.8 (4.5)
SWB, Baseline (n=55,53)	15.9 (6.3)	15.2 (6.8)
SWB, Cycle 2 (n=52,40)	15.5 (6.7)	14.7 (7.2)
SWB, Cycle 3 (n=42,30)	16.0 (6.9)	16.5 (6.8)
SWB, Cycle 4 (n=37,27)	15.9 (7.0)	16.1 (7.1)
SWB, Cycle 5 (n=28,21)	15.7 (7.0)	15.1 (7.7)
SWB, Cycle 6 (n=26,18)	15.2 (7.8)	17.4 (7.1)
SWB, End of Study (n=52,47)	14.4 (7.1)	14.3 (7.6)
EWB, Baseline (n=57,55)	7.8 (3.7)	6.5 (3.4)
EWB, Cycle 2 (n=52,43)	6.7 (3.8)	5.9 (3.2)
EWB, Cycle 3 (n=42,29)	6.4 (3.5)	5.6 (2.8)
EWB, Cycle 4 (n=37,27)	7.0 (3.6)	6.0 (4.6)
EWB, Cycle 5 (n=29,21)	6.3 (3.6)	5.5 (4.7)
EWB, Cycle 6 (n=25,20)	6.5 (3.5)	4.8 (3.1)
EWB, End of Study (n=52,50)	7.1 (4.1)	6.0 (3.4)
FWB, Baseline (n=56,55)	12.3 (6.2)	13.3 (7.4)
FWB, Cycle 2 (n=51,41)	12.9 (7.1)	12.9 (7.1)
FWB, Cycle 3 (n=41,27)	13.0 (7.4)	12.9 (6.9)
FWB, Cycle 4 (n=37,26)	12.8 (7.2)	11.3 (7.8)
FWB, Cycle 5 (n=29,22)	12.7 (6.2)	12.0 (7.6)
FWB, Cycle 6 (n=25,20)	11.7 (6.4)	11.4 (6.3)
FWB, End of Study (n=51,50)	11.1 (7.2)	11.5 (7.2)
LCS, Baseline (n=56,54)	11.0 (3.2)	11.1 (3.8)
LCS, Cycle 2 (n=50,45)	10.8 (3.1)	11.2 (3.5)
LCS, Cycle 3 (n=42,30)	11.0 (3.1)	10.5 (3.2)
LCS, Cycle 4 (n=37,27)	11.3 (3.1)	10.2 (3.2)
LCS, Cycle 5 (n=28,21)	10.8 (3.0)	10.0 (3.9)
LCS, Cycle 6 (n=26,20)	10.4 (2.9)	9.9 (4.0)
LCS, End of Study (n=52,50)	11.1 (3.2)	10.8 (3.2)

9. Secondary Outcome

Title	Changes in Quality of Life as Measured by the FACT Questionnaire
Description	The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, response of down, up or no change were defined as score changes of less than or equal to (≤)2, greater than or equal to (≥)+2, or between these values.
Time Frame	Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study

Outcome Measure Data

Analysis Population Description

Safety Population; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Erlotinib	Vinorelbine
Arm/Group Description	Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.	Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off. Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.
Measure Participants	52	48
PWB, Baseline (n=51,45)	6.5 (3.8)	6.0 (3.4)
PWB, Endpoint (n=51,45)	10.8 (5.2)	7.8 (4.6)
Change in PWB (n=51,45)	4.3 (5.5)	1.8 (4.7)
SWB, Baseline (n=50,45)	15.8 (6.5)	15.4 (6.7)
SWB, Endpoint (n=50,45)	14.3 (7.2)	14.4 (7.7)
Change in SWB (n=50,45)	-1.5 (4.8)	-1.0 (6.0)
EWB, Baseline (n=52,48)	7.9 (3.7)	6.2 (3.2)
EWB, Endpoint (n=52,48)	7.1 (4.1)	6.0 (3.4)
Change in EWB (n=52,48)	-0.8 (4.4)	-0.2 (4.0)
FWB, Baseline (n=51,48)	12.6 (6.2)	13.4 (7.4)
FWB, Endpoint (n=51,48)	11.1 (7.2)	11.7 (7.2)
Change in FWB (n=51,48)	-1.5 (5.1)	-1.7 (6.0)
LCS, Baseline (n=51,47)	10.9 (3.3)	11.2 (4.0)
LCS, Endpoint (n=51,47)	11.2 (3.2)	10.7 (3.0)
Change in LCS (n=51,47)	0.3 (3.3)	-0.4 (4.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Erlotinib, Vinorelbine
	Comments	PWB, Baseline versus Endpoint
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0060
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Erlotinib, Vinorelbine
	Comments	SWB, Baseline versus Endpoint
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6871
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Erlotinib, Vinorelbine
	Comments	EWB Baseline versus Endpoint
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5104
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Erlotinib, Vinorelbine
	Comments	FWB, Baseline versus Endpoint
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9927
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Erlotinib, Vinorelbine
	Comments	LCS, Baseline versus Endpoint
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3581
	Comments
	Method	ANOVA
	Comments

10. Secondary Outcome

Title	Percentage of Participants With Changes in Quality of Life as Measured by FACT Questionnaire Scores by Category of Change
Description	The FACT and the FACT-L contain 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented Worsened'. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, higher scores indicated a better outcome; a response of down, up, or no change was defined as a score change of ≤ -2 (score down), ≥ +2 (score up), or between these values.
Time Frame	Baseline and End of study

Outcome Measure Data

Analysis Population Description

Safety Population; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Erlotinib	Vinorelbine
Arm/Group Description	Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.	Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off. Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.
Measure Participants	52	48
PWB, Score Down (n=51,45)	7.8 13.7%	22.2 39.6%
PWB, No Change (n=51,45)	33.3 58.4%	31.1 55.5%
PWB, Score Up (n=51,45)	58.8 103.2%	46.7 83.4%
SWB, Score Down (n=50,45)	40.0 70.2%	37.8 67.5%
SWB, No Change (n=50,45)	40.0 70.2%	40.0 71.4%
SWB, Score Up (n=50,45)	20.0 35.1%	22.2 39.6%
EWB, Score Down (n=52,48)	38.5 67.5%	33.3 59.5%
EWB, No Change (n=52,48)	38.5 67.5%	41.7 74.5%
EWB, Score Up (n=52,48)	23.1 40.5%	25.0 44.6%
FWB, Score Down (n=51,48)	41.2 72.3%	41.7 74.5%
FWB, No Change (n=51,48)	33.3 58.4%	35.4 63.2%
FWB, Score Up (n=51,48)	25.5 44.7%	22.9 40.9%
LCS, Score Down (n=51,47)	17.6 30.9%	31.9 57%
LCS, No Change (n=51,47)	47.1 82.6%	40.4 72.1%
LCS, Score Up (n=51,47)	35.3 61.9%	27.7 49.5%

11. Secondary Outcome

Title	Changes in Quality of Life as Assessed by FACT-L (Lung Symptoms) Questionnaire
Description	The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition) rated on a five-point scale from 0 (not at all) to 4 (very much). The LCS total score is the sum of the scores from the 7 items. For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The change of FACT-L subscore was the change from baseline to endpoint. The LCS of FACT-L is an independently validated tool that measures the disease-related symptoms of lung cancer on an overall scale of 0 (most symptomatic) to 28 (asymptomatic).
Time Frame	Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study

Outcome Measure Data

Analysis Population Description

Safety Population; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Erlotinib	Vinorelbine
Arm/Group Description	Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.	Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off. Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.
Measure Participants	52	48
Shortness of breath, Baseline (n=52,48)	1.4 (0.7)	1.4 (1.1)
Shortness of breath, Endpoint (n=52,48)	1.6 (1.0)	1.3 (0.9)
Shortness of breath, Change (n=52,48)	0.2 (0.8)	-0.1 (1.2)
Weight loss, Baseline (n=51,47)	0.6 (0.8)	0.8 (1.0)
Weight loss, Endpoint (n=51,47)	0.7 (0.9)	0.6 (0.7)
Weight loss, Change (n=51,47)	0.1 (1.0)	-0.2 (1.2)
Clear thinking, Baseline (n=52,48)	2.4 (1.2)	2.3 (1.3)
Clear thinking, Endpoint (n=52,48)	2.2 (1.3)	2.4 (1.3)
Clear thinking, Change (n=52,48)	-0.2 (1.1)	0.1 (1.5)
Coughing, Baseline (n=52,48)	1.3 (0.6)	1.4 (1.0)
Coughing, Endpoint (n=52,48)	1.4 (0.7)	1.4 (0.8)
Coughing, Change (n=52,48)	0.1 (0.8)	-0.0 (1.2)
Hair loss, Baseline (n=52,48)	0.3 (0.6)	0.6 (1.1)
Hair loss, Endpoint (n=52,48)	0.4 (0.7)	0.4 (0.6)
Hair loss, Change (n=52,48)	0.1 (0.8)	-0.1 (1.2)
Good appetite, Baseline (n=52,48)	1.9 (0.9)	2.0 (1.2)
Good appetite, Endpoint (n=52,48)	1.7 (1.1)	1.7 (1.0)
Good appetite, Change (n=52,48)	-0.3 (0.9)	-0.4 (1.3)
Tightness in chest, Baseline (n=52,48)	1.3 (0.8)	1.2 (0.9)
Tightness in chest, Endpoint (n=52,48)	1.4 (0.8)	1.3 (1.0)
Tightness in chest, Change (n=52,48)	0.1 (0.9)	0.1 (1.2)
Easy breathing, Baseline (n=52,48)	1.7 (0.9)	1.7 (1.1)
Easy breathing, Endpoint (n=52,48)	1.7 (0.9)	1.6 (1.1)
Easy breathing, Change (n=52,48)	-0.1 (1.1)	-0.0 (1.3)

12. Secondary Outcome

Title	Percentage of Participants With Changes in FACT-L (Lung Symptoms) by Category of Change
Description	The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items, each rated on a five-point scale from 0 (not at all) to 4 (very much). For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. For each FACT-L question, the response status was defined as down, up, or no change if the score at endpoint was smaller (score down), larger than (score up), or the same as (no change) that at baseline.
Time Frame	Baseline and End of study

Outcome Measure Data

Analysis Population Description

Safety Population; n=number of participants assessed for the specified parameter at a given visit.

Arm/Group Title	Erlotinib	Vinorelbine
Arm/Group Description	Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.	Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off. Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.
Measure Participants	52	48
Shortness of breath, Score Down (n=52,48)	17.3 30.4%	18.8 33.6%
Shortness of breath, No Change (n=52,48)	51.9 91.1%	58.3 104.1%
Shortness of breath, Score Up (n=52,48)	30.8 54%	22.9 40.9%
Weight loss, Score Down (n=51,47)	19.6 34.4%	31.9 57%
Weight loss, No Change (n=51,47)	51.0 89.5%	44.7 79.8%
Weight loss, Score Up (n=51,47)	29.4 51.6%	23.4 41.8%
Clear thinking, Score Down (n=52,48)	26.9 47.2%	27.1 48.4%
Clear thinking No Change (n=52,48)	53.8 94.4%	43.8 78.2%
Clear thinking, Score Up (n=52,48)	19.2 33.7%	29.2 52.1%
Coughing, Score Down (n=52,48)	21.2 37.2%	22.9 40.9%
Coughing, No Change (n=52,48)	53.8 94.4%	50.0 89.3%
Coughing, Score Up (n=52,48)	25.0 43.9%	27.1 48.4%
Hair loss, Score Down (n=52,48)	13.5 23.7%	18.8 33.6%
Hair loss, No Change (n=52,48)	65.4 114.7%	60.4 107.9%
Hair loss, Score Up (n=52,48)	21.2 37.2%	20.8 37.1%
Good appetite, Score Down (n=52,48)	26.9 47.2%	35.4 63.2%
Good appetite, No Change (n=52,48)	61.5 107.9%	45.8 81.8%
Good appetite, Score Up (n=52,48)	11.5 20.2%	18.8 33.6%
Tightness in chest, Score Down (n=52,48)	17.3 30.4%	22.9 40.9%
Tightness in chest, No Change (n=52,48)	55.8 97.9%	54.2 96.8%
Tightness in chest, Score Up (n=52,48)	26.9 47.2%	22.9 40.9%
Easy breathing, Score Down (n=52,48)	28.8 50.5%	22.9 40.9%
Easy breathing, No Change (n=52,48)	48.1 84.4%	58.3 104.1%
Easy breathing, Score Up (n=52,48)	23.1 40.5%	18.8 33.6%

Adverse Events

Time Frame	Adverse Events were monitored continuously during the study treatment and for 28 days after the last intake of study medication. Only SAE were recorded during post study treatment phase and for 28 days after the last intake of study medication.
Arm/Group Title	Erlotinib		Vinorelbine
Arm/Group Description	Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.		Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off. Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.
All Cause Mortality
	Erlotinib		Vinorelbine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Erlotinib		Vinorelbine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/57 (33.3%)		14/57 (24.6%)
Blood and lymphatic system disorders
Febrile neutropenia	0/57 (0%)		3/57 (5.3%)
Neutropenia	0/57 (0%)		1/57 (1.8%)
Cardiac disorders
Cardiogenic shock	1/57 (1.8%)		0/57 (0%)
Cardiopulmonary failure	1/57 (1.8%)		0/57 (0%)
Cardiac arrest	0/57 (0%)		1/57 (1.8%)
Gastrointestinal disorders
Gastrointestinal haemorrhage	1/57 (1.8%)		0/57 (0%)
Melaena	0/57 (0%)		1/57 (1.8%)
Vomiting	0/57 (0%)		1/57 (1.8%)
General disorders
Asthenia	1/57 (1.8%)		0/57 (0%)
Pyrexia	0/57 (0%)		1/57 (1.8%)
Chest Discomfort	0/57 (0%)		1/57 (1.8%)
Chest pain	0/57 (0%)		1/57 (1.8%)
Hepatobiliary disorders
Hepatitis	1/57 (1.8%)		0/57 (0%)
Jaundice	1/57 (1.8%)		0/57 (0%)
Infections and infestations
Urinary tract infection	1/57 (1.8%)		0/57 (0%)
Pneumonia	4/57 (7%)		6/57 (10.5%)
Herpes zoster	1/57 (1.8%)		0/57 (0%)
Septic shock	0/57 (0%)		1/57 (1.8%)
Cellulitis	0/57 (0%)		1/57 (1.8%)
Injury, poisoning and procedural complications
Femoral neck fracture	1/57 (1.8%)		0/57 (0%)
Spinal fracture	1/57 (1.8%)		0/57 (0%)
Subdural haematoma	0/57 (0%)		1/57 (1.8%)
Metabolism and nutrition disorders
Hypoglycaemia	1/57 (1.8%)		0/57 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma	1/57 (1.8%)		0/57 (0%)
Nervous system disorders
Extrapyramidal disorder	1/57 (1.8%)		0/57 (0%)
Parkinsonism	1/57 (1.8%)		0/57 (0%)
Syncope	0/57 (0%)		1/57 (1.8%)
Psychiatric disorders
Alcohol withdrawal syndrome	1/57 (1.8%)		0/57 (0%)
Depression	0/57 (0%)		1/57 (1.8%)
Renal and urinary disorders
Renal failure acute	1/57 (1.8%)		0/57 (0%)
Respiratory, thoracic and mediastinal disorders
Hiccups	1/57 (1.8%)		0/57 (0%)
Respiratory failure	1/57 (1.8%)		1/57 (1.8%)
Acute respiratory failure	1/57 (1.8%)		0/57 (0%)
Pneumonia aspiration	1/57 (1.8%)		0/57 (0%)
Chronic obstructive pulmonary disease	0/57 (0%)		1/57 (1.8%)
Dyspnoea	0/57 (0%)		1/57 (1.8%)
Vascular disorders
Infarction	1/57 (1.8%)		0/57 (0%)
Other (Not Including Serious) Adverse Events
	Erlotinib		Vinorelbine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	54/55 (98.2%)		53/54 (98.1%)
Blood and lymphatic system disorders
Anaemia	3/55 (5.5%)		1/54 (1.9%)
Gastrointestinal disorders
Diarrhoea	20/55 (36.4%)		7/54 (13%)
Mouth ulceration	9/55 (16.4%)		1/54 (1.9%)
Constipation	7/55 (12.7%)		7/54 (13%)
Vomiting	4/55 (7.3%)		6/54 (11.1%)
Abdominal pain upper	3/55 (5.5%)		4/54 (7.4%)
Nausea	3/55 (5.5%)		5/54 (9.3%)
Stomatitis	3/55 (5.5%)		4/54 (7.4%)
Abdominal distension	2/55 (3.6%)		4/54 (7.4%)
Gastrooesophageal reflux disease	3/55 (5.5%)		0/54 (0%)
General disorders
Pyrexia	3/55 (5.5%)		8/54 (14.8%)
Fatigue	1/55 (1.8%)		6/54 (11.1%)
Oedema	3/55 (5.5%)		4/54 (7.4%)
Infections and infestations
Conjunctivitis	3/55 (5.5%)		1/54 (1.9%)
Tinea cruris	3/55 (5.5%)		0/54 (0%)
Folliculitis	4/55 (7.3%)		0/54 (0%)
Metabolism and nutrition disorders
Decreased appetite	16/55 (29.1%)		24/54 (44.4%)
Musculoskeletal and connective tissue disorders
Back pain	3/55 (5.5%)		2/54 (3.7%)
Nervous system disorders
Headache	3/55 (5.5%)		2/54 (3.7%)
Psychiatric disorders
Insomnia	5/55 (9.1%)		7/54 (13%)
Respiratory, thoracic and mediastinal disorders
Mucosal inflammation	5/55 (9.1%)		1/54 (1.9%)
Productive cough	3/55 (5.5%)		2/54 (3.7%)
Oropharyngeal pain	3/55 (5.5%)		0/54 (0%)
Rhinorrhoea	2/55 (3.6%)		3/54 (5.6%)
Hiccups	3/55 (5.5%)		0/54 (0%)
Skin and subcutaneous tissue disorders
Rash	38/55 (69.1%)		3/54 (5.6%)
Vascular disorders
Hypertension	3/55 (5.5%)		0/54 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.