A Study of Tarceva (Erlotinib) in Sequential Combination... | NCT00940875

Label	Type	Description	Intervention Names
1	Experimental		Drug: erlotinib [Tarceva] Drug: gemcitabine
2	Active Comparator		Drug: gemcitabine

Name	Type	Description	Arm Group Labels	Other Names
erlotinib [Tarceva]	Drug	150mg po on days 15-28 of each 4 week cycle	1

Measure	Description	Time Frame
Percentage of Participants With Disease Progression or Death	Progression-free survival (PFS) was defined as the time from randomization to the date of first documentation of progressive disease (PD), according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V) 1.0, or date of death from any cause. PD was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-Baseline (BL) tumor assessment who were known to be alive were censored at the date of randomization.	BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).
PFS	The median time, in weeks, between randomization and PFS event. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-BL tumor assessment who were known to be alive were censored at the date of randomization. PFS was estimated by using Kaplan-Meier methodology.	BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (up to 2 years)

Measure	Description	Time Frame
Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0	As per RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper Method.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Port Macquarie	New South Wales	2444	Australia

ID	Title	Description
FG000	Gemcitabine Monotherapy	Participants received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
FG001	Gemcitabine (G) Plus (+) Erlotinib (E)

ID	Title	Description
BG000	Gemcitabine Monotherapy	Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
BG001	Gemcitabine + Erlotinib	Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Disease Progression or Death

Progression-free survival (PFS) was defined as the time from randomization to the date of first documentation of progressive disease (PD), according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V) 1.0, or date of death from any cause. PD was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-Baseline (BL) tumor assessment who were known to be alive were censored at the date of randomization.

FAS

Posted

Number

percentage of participants

BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).

ID	Title	Description
OG000	Gemcitabine Monotherapy	Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
OG001	Gemcitabine + Erlotinib	Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).

Units	Counts
Participants	OG00028 OG00126

Title

Denominators

Categories

Title	Measurements
	OG00096.4 OG00196.2

Secondary

Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0

As per RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper Method.

FAS

Posted

Number

95% Confidence Interval

percentage of participants

BL, Day 22 of Cycle 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).

ID	Title	Description
OG000	Gemcitabine Monotherapy	Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
OG001	Gemcitabine + Erlotinib	Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).

Primary

PFS

The median time, in weeks, between randomization and PFS event. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-BL tumor assessment who were known to be alive were censored at the date of randomization. PFS was estimated by using Kaplan-Meier methodology.

FAS

Posted

Median

95% Confidence Interval

weeks

BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (up to 2 years)

ID	Title	Description
OG000	Gemcitabine Monotherapy	Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
OG001	Gemcitabine + Erlotinib	Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).

Secondary

Percentage of Participants With Non-Progression at Weeks 8 and 16

Non-progression was defined as CR, PR, or stable disease according to RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD recorded since the start of treatment. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and SD was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above the normal limits. The 95% CI for one-sample binomial was determined using the Pearson-Clopper method.

FAS

Posted

Number

95% Confidence Interval

percentage of participants

Weeks 8 and 16

ID	Title	Description
OG000	Gemcitabine Monotherapy	Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
OG001	Gemcitabine + Erlotinib	Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).

Secondary

Percentage of Participants Who Died

FAS

Posted

Number

percentage of participants

BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.

ID	Title	Description
OG000	Gemcitabine Monotherapy	Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
OG001	Gemcitabine+ Erlotinib	Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS)

OS was defined as the median time, in weeks, between randomization and death due to any cause. Participants without documented death were censored at the last date recorded in the drug log, or the last date of follow-up the participant was known to be alive, whichever was last. Participants without a post-BL assessment who were known to be alive were censored at the date of randomization. OS was estimated using Kaplan-Meier methodology.

FAS

Posted

Median

95% Confidence Interval

weeks

BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.

ID	Title	Description
OG000	Gemcitabine Monotherapy	Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
OG001	Gemcitabine + Erlotinib	Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).

Secondary

Duration of Response

Duration of response was defined as the time between the first documentation of CR or PR (whichever status was recorded first as assessed by the RECIST V 1.0) until the date of documented disease progression or death. Participants with no documented disease progression or death after confirmed CR or PR were censored at the date of the last tumor assessment or last date of follow-up when the participant was known to be progression free, whichever was last.

Data could not be summarized to be included in the data table because there are too few events to calculate a median and confidence intervals.

Posted

BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.

ID	Title	Description
OG000	Gemcitabine Monotherapy	Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
OG001	Gemcitabine+ Erlotinib	Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected23 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected23 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Pulmomary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected23 at risk
Pneumonia	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected23 at risk
Cellulitis	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Herpes zoster	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Lung infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Otitis externa	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Sepsis	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Septic shock	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Pyrexia	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0004 affected31 at risk EG0012 affected23 at risk
Malaise	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Pain	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Sudden death	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected23 at risk
Constipation	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected23 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Atrial flutter	Cardiac disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Embolism venous	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Hypotension	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Peripheral embolism	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Anxiety	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Confusional state	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Mood altered	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Haemoglobin decreased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Troponin increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected23 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Renal impairment	Renal and urinary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG00013 affected31 at risk EG00113 affected23 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0003 affected31 at risk EG00112 affected23 at risk
Constipation	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0006 affected31 at risk EG0017 affected23 at risk
Vomiting	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0005 affected31 at risk EG0016 affected23 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0003 affected31 at risk EG0012 affected23 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0015 affected23 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0013 affected23 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected23 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected23 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected23 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected23 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected23 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Gingival pain	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Toothache	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Fatigue	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0007 affected31 at risk EG00110 affected23 at risk
Oedema peripheral	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0008 affected31 at risk EG0014 affected23 at risk
Chest pain	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0005 affected31 at risk EG0015 affected23 at risk
Pyrexia	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0003 affected31 at risk EG0011 affected23 at risk
Mucosal inflammation	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0004 affected31 at risk EG0013 affected23 at risk
Pain	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected31 at risk EG0011 affected23 at risk
Ill-defined disorder	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Influenza like illness	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Injection site reaction	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0005 affected31 at risk EG0012 affected23 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0004 affected31 at risk EG0012 affected23 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0013 affected23 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0013 affected23 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0013 affected23 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0012 affected23 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected23 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected23 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0007 affected31 at risk EG0017 affected23 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0004 affected31 at risk EG0013 affected23 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected23 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected23 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Pulmonary hilum mass	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Respiratory tract haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Sputum retention	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected31 at risk EG0012 affected23 at risk
Oral candidiasis	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0004 affected31 at risk EG0011 affected23 at risk
Cellulitis	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0003 affected31 at risk EG0010 affected23 at risk
Lung infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected23 at risk
Pneumonia	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0012 affected23 at risk
Sepsis	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Furuncle	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Paronychia	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Respiratory tract infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0005 affected31 at risk EG00115 affected23 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0014 affected23 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected23 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected23 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Pericardial effusion	Cardiac disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0012 affected23 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Deafness	Ear and labyrinth disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Dizziness	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0004 affected31 at risk EG0012 affected23 at risk
Headache	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0003 affected31 at risk EG0012 affected23 at risk
Lethargy	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0003 affected31 at risk EG0011 affected23 at risk
Ataxia	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected23 at risk
Paraesthesia	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected23 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Dizziness postural	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Dysgeusia	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Hemiparesis	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Intention tremor	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Pyramidal tract syndrome	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Syncope	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Tardive dyskinesia	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Tremor	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Hypotension	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0015 affected23 at risk
Hypertension	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected23 at risk
Ischaemic limb pain	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Thrombophlebitis	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Venous thrombosis limb	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Blepharitis	Eye disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Dry eye	Eye disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Exophthalmos	Eye disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Eye irritation	Eye disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Eye pain	Eye disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Foreign body sensation in eyes	Eye disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Uveitis	Eye disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Vision blurred	Eye disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Visual impairment	Eye disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0012 affected23 at risk
Renal impairment	Renal and urinary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Dysuria	Renal and urinary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Haematuria	Renal and urinary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Urinary retention	Renal and urinary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Weight decreased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0003 affected31 at risk EG0012 affected23 at risk
Alanine aminotransferase increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected31 at risk EG0011 affected23 at risk
Haemoglobin decreased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0012 affected23 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected23 at risk
Platelet count decreased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected23 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Eastern cooperative oncology group performance status worsened	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Hepatic enzyme increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Liver function test abnormal	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Platelet count increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Weight increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0006 affected31 at risk EG0017 affected23 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0004 affected31 at risk EG0011 affected23 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0003 affected31 at risk EG0012 affected23 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0004 affected31 at risk EG0012 affected23 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected31 at risk EG0012 affected23 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected23 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected23 at risk
Gout	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Confusional state	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected31 at risk EG0011 affected23 at risk
Insomnia	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0013 affected23 at risk
Anxiety	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected23 at risk
Depression	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected31 at risk EG0011 affected23 at risk
Agitation	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected23 at risk
Delirium	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk
Depressed mood	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected23 at risk

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Gemcitabine Monotherapy	Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.			20	31	28	31
EG001	Gemcitabine + Erlotinib	Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).			14	23	22	23