Erlotinib and Gemcitabine With or Without Panitumumab in... | NCT00550836

ID	Type	Description	Link
NCI-2009-01089	Registry Identifier	CTRP (Clinical Trials Reporting System)
CDR0000571863	Registry Identifier	PDQ (Physician Data Query)

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Detailed Description

OBJECTIVES:

Primary

To assess whether the addition of panitumumab (a dual-epidermal growth factor receptor inhibitor) to standard chemotherapy comprising gemcitabine hydrochloride and erlotinib hydrochloride results in an improvement in overall survival of patients with previously untreated, metastatic adenocarcinoma of the pancreas.

Secondary

To compare objective response rates, progression-free survival, time to treatment failure, quality of life, and adverse event rates in patients treated with these regimens.
To evaluate the downstream marker, KRAS, in stool specimens.

OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status (0 vs 1) and prior adjuvant chemotherapy (yes vs no). The first 6 patients are assigned to arm II. Subsequent patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above in the absence of disease progression or unacceptable toxicity. Patients achieving a CR after 4 courses of treatment receive maintenance therapy comprising erlotinib hydrochloride daily until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression (using the first progression tumor measurements as the new baseline reference).
Arm II: Patients receive gemcitabine hydrochloride and erlotinib hydrochloride as in arm I and panitumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above in the absence of disease progression or unacceptable toxicity. Patients achieving a CR after 4 courses of treatment receive maintenance therapy comprising erlotinib hydrochloride daily and panitumumab every 2 weeks until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression (using the first progression tumor measurements as the new baseline reference).

Stool samples are collected at baseline and analyzed for KRAS mutations via protein analyses.

Quality of life will be assessed at baseline, every 2 courses during treatment, and at the end of treatment.

After the second progression, patients are followed every 3-6 months for 2 years.

Label	Type	Description	Intervention Names
Arm A: GE	Active Comparator	Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.	Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride
Arm B: PGE	Experimental	Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.	Biological: panitumumab Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride

Name	Type	Description	Arm Group Labels	Other Names
panitumumab	Biological	Given IV	Arm B: PGE
erlotinib hydrochloride

Measure	Description	Time Frame
Overall Survival	Overall Survival is defined as the time from registration to death due to any cause. The estimate will be done using the Kaplan-Meier method. The primary goal of this trial is to compare the experimental arm (Arm B) to the standard arm (Arm A). The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves.	Up to 2 years

Measure	Description	Time Frame
Confirmed Response Rate	Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed adenocarcinoma of the pancreas (ductal or undifferentiated)
- Metastatic disease
No islet cell, acinar cell, or cystadenocarcinomas
No locally advanced disease
No history or known presence of CNS metastases

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
Life expectancy ≥ 3 months
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Total bilirubin ≤ 2 times upper limit of normal (ULN) (patients may be stented)
AST ≤ 2.5 times ULN
Creatinine ≤ 2.0 times ULN
Magnesium ≥ lower limit of normal
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Willing to provide a stool specimen
No malignancy diagnosed within the past 3 years except basal cell or squamous cell skin cancer, prostate cancer (Gleason < 7), or carcinoma in situ of the cervix
No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
No clinically significant cardiovascular disease (i.e., myocardial infarction, unstable angina, symptomatic congestive heart failure, or serious uncontrolled cardiac arrhythmia) within the past year
No known positive test(s) for HIV infection, hepatitis C virus, or acute or chronic active hepatitis B infection
No liver dysfunction from cirrhosis or viral hepatitis
No enteral hyperalimentation
No grapefruit or grapefruit juice during the study

PRIOR CONCURRENT THERAPY:

Recovered from prior therapy
More than 4 months since prior radiotherapy, immunotherapy, or biologic therapy
More than 4 weeks since prior and no elective or planned major surgery
More than 2 weeks since prior minor and no elective or planned surgery
No prior cytotoxic chemotherapy for metastatic disease
- Adjuvant chemotherapy for completely resected disease or chemoradiotherapy for locally advanced disease is allowed, provided it was administered > 6 months prior to study entry
  - Adjuvant chemotherapy must not have contained an EGFR inhibitor
- Gemcitabine hydrochloride used as either a radiosensitizer or as maintenance therapy is allowed, provided more than 6 months have elapsed since the last day of treatment
No prior anti-EGFR antibody therapy (e.g., cetuximab) or treatment with small molecule EGFR inhibitors (e.g., gefitinib hydrochloride, erlotinib hydrochloride, or lapatinib)
No concurrent immunotherapy or radiotherapy
No other concurrent chemotherapy
No concurrent colony-stimulating factors during the first course of study therapy

Name	Affiliation	Role
George P. Kim, MD	Mayo Clinic	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Aurora Presbyterian Hospital		Aurora	Colorado	80012	United States
Boulder Community Hospital

PubMed Identifier	Type	Citation	Retractions
30679315	Derived	Halfdanarson TR, Foster NR, Kim GP, Meyers JP, Smyrk TC, McCullough AE, Ames MM, Jaffe JP, Alberts SR. A Phase II Randomized Trial of Panitumumab, Erlotinib, and Gemcitabine Versus Erlotinib and Gemcitabine in Patients with Untreated, Metastatic Pancreatic Adenocarcinoma: North Central Cancer Treatment Group Trial N064B (Alliance). Oncologist. 2019 May;24(5):589-e160. doi: 10.1634/theoncologist.2018-0878. Epub 2019 Jan 24.

ID	Title	Description
FG000	Arm A: GE	Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.

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

Overall Survival

Overall Survival is defined as the time from registration to death due to any cause. The estimate will be done using the Kaplan-Meier method. The primary goal of this trial is to compare the experimental arm (Arm B) to the standard arm (Arm A). The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves.

All treated patients that were eligible were included in the analysis.

Posted

Median

95% Confidence Interval

months

Up to 2 years

ID	Title	Description
OG000	Arm A: GE	Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
OG001	Arm B: PGE	Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.

Units	Counts
Participants	OG00046 OG00146

Title

Denominators

Categories

Title	Measurements
	OG0004.2(3.5 to 7.8) OG0018.3(4.5 to 10)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	It was calculated that 39 participants randomized in a 1:1 fashion between the 2 arms would have 80% to detect a difference in median survival of 6 vs. 9.7 months for GE vs. PGE respectively with a minimum follow up of 6 months. Sample size was determined using a 1-sided log-rank test at alpha=0.20.	Log Rank		0.36														Superiority

Secondary

Confirmed Response Rate

Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.

All patients that started protocol treatment and were evaluated were included in this analysis.

Posted

Number

95% Confidence Interval

rate of confirmed response

Up to 2 years

ID	Title	Description
OG000	Arm A: GE	Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
OG001	Arm B: PGE	Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.

Secondary

Progression-free Survival

Progression-free survival is defined as the time from randomization to documentation of disease progression or death, whichever comes first. Progression is defined as at least a 20% increase in the sum of longest dimension (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. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. The progression-free survival curves will be compared between the 2 arms using a log-rank test.

All treated patients were included in this analysis.

Posted

Median

95% Confidence Interval

months

Up to 2 years

ID	Title	Description
OG000	Arm A: GE	Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
OG001	Arm B: PGE	Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.

Secondary

Time to Treatment Failure

Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a nonprotocol failure, the patient will be censored on the date they are removed from treatment. The time to treatment failure will be estimated using the method of Kaplan-Meier.

All eligible treated patients were included in this analysis.

Posted

Median

95% Confidence Interval

months

Up to 2 years

ID	Title	Description
OG000	Arm A: GE	Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
OG001	Arm B: PGE	Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.

Secondary

Frequency and Severity of Observed Adverse Effects

Patients are assessed for Adverse events each cycle using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). The maximum grade for each type of adverse event will be recorded for each patient, and tables will be reviewed to determine adverse event patterns. The number of patients in each arm that reported a grade 3 or higher adverse event and a grade 4 or higher adverse event are reported.

A complete listing of all adverse events is reported in the Adverse Events section.

All evaluable patients were included in this analysis.

Posted

Number

participants

Up to 2 years

ID	Title	Description
OG000	Arm A: GE	Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
OG001	Arm B: PGE	Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Hemoglobin decreased	Blood and lymphatic system disorders	MedDRA 9	Systematic Assessment	EG0006 events6 affected46 at risk EG0016 events6 affected46 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0007 events7 affected46 at risk EG0012 events2 affected46 at risk
Ascites	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0002 events2 affected46 at risk EG0010 events0 affected46 at risk
Constipation	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0003 events2 affected46 at risk EG0012 events2 affected46 at risk
Duodenal hemorrhage	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0012 events2 affected46 at risk
Duodenal obstruction	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected46 at risk
Enteritis	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Ileus	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0002 events2 affected46 at risk EG0010 events0 affected46 at risk
Intra-abdominal hemorrhage	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Jejunal obstruction	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Lower gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Nausea	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG00010 events10 affected46 at risk EG0014 events3 affected46 at risk
Rectal hemorrhage	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Upper gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Vomiting	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0009 events9 affected46 at risk EG0014 events4 affected46 at risk
Chest pain	General disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Death	General disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0012 events2 affected46 at risk
Disease progression	General disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Edema limbs	General disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Fatigue	General disorders	MedDRA 9	Systematic Assessment	EG0005 events5 affected46 at risk EG0014 events4 affected46 at risk
Fever	General disorders	MedDRA 9	Systematic Assessment	EG0002 events2 affected46 at risk EG0012 events2 affected46 at risk
Pain	General disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0012 events2 affected46 at risk
Gallbladder obstruction	Hepatobiliary disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Bladder infection	Infections and infestations	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Catheter related infection	Infections and infestations	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Gallbladder infection	Infections and infestations	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Infectious colitis	Infections and infestations	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0012 events2 affected46 at risk
Pneumonia	Infections and infestations	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Sepsis	Infections and infestations	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected46 at risk
Skin infection	Infections and infestations	MedDRA 9	Systematic Assessment	EG0002 events2 affected46 at risk EG0010 events0 affected46 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected46 at risk
Alanine aminotransferase increased	Investigations	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Alkaline phosphatase increased	Investigations	MedDRA 9	Systematic Assessment	EG0004 events3 affected46 at risk EG0012 events2 affected46 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0012 events2 affected46 at risk
Bilirubin increased	Investigations	MedDRA 9	Systematic Assessment	EG0004 events4 affected46 at risk EG0013 events3 affected46 at risk
Creatinine increased	Investigations	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Lipase increased	Investigations	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected46 at risk
Platelet count decreased	Investigations	MedDRA 9	Systematic Assessment	EG0003 events3 affected46 at risk EG0012 events2 affected46 at risk
Weight loss	Investigations	MedDRA 9	Systematic Assessment	EG0002 events2 affected46 at risk EG0011 events1 affected46 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0004 events4 affected46 at risk EG0011 events1 affected46 at risk
Blood glucose increased	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0003 events3 affected46 at risk EG0011 events1 affected46 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0004 events3 affected46 at risk EG0012 events2 affected46 at risk
Serum albumin decreased	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected46 at risk
Serum calcium decreased	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Serum magnesium decreased	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0012 events2 affected46 at risk
Serum phosphate decreased	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Serum potassium decreased	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Serum sodium decreased	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0013 events3 affected46 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 9	Systematic Assessment	EG0004 events3 affected46 at risk EG0010 events0 affected46 at risk
Muscle weakness	Musculoskeletal and connective tissue disorders	MedDRA 9	Systematic Assessment	EG0002 events2 affected46 at risk EG0011 events1 affected46 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Dizziness	Nervous system disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Ischemia cerebrovascular	Nervous system disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0012 events2 affected46 at risk
Syncope	Nervous system disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Confusion	Psychiatric disorders	MedDRA 9	Systematic Assessment	EG0002 events2 affected46 at risk EG0010 events0 affected46 at risk
Insomnia	Psychiatric disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Psychosis	Psychiatric disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Renal failure	Renal and urinary disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 9	Systematic Assessment	EG0003 events3 affected46 at risk EG0014 events4 affected46 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected46 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0012 events2 affected46 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0012 events2 affected46 at risk
Rash desquamating	Skin and subcutaneous tissue disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Skin ulceration	Skin and subcutaneous tissue disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Hypertension	Vascular disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0012 events2 affected46 at risk
Hypotension	Vascular disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected46 at risk
Thrombosis	Vascular disorders	MedDRA 9	Systematic Assessment	EG0009 events9 affected46 at risk EG0016 events6 affected46 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Hemoglobin decreased	Blood and lymphatic system disorders	MedDRA 9	Systematic Assessment	EG00011 events8 affected46 at risk EG00121 events10 affected46 at risk
Hemolysis	Blood and lymphatic system disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0012 events1 affected46 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0008 events4 affected46 at risk EG0016 events5 affected46 at risk
Ascites	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0014 events4 affected46 at risk
Constipation	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG00013 events5 affected46 at risk EG0012 events1 affected46 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG00047 events25 affected46 at risk EG00160 events24 affected46 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected46 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected46 at risk
Ear, nose and throat examination abnormal	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0002 events2 affected46 at risk EG0010 events0 affected46 at risk
Flatulence	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Lower gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Mucositis oral	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Nausea	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG00064 events30 affected46 at risk EG00179 events35 affected46 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Vomiting	Gastrointestinal disorders	MedDRA 9	Systematic Assessment	EG00021 events13 affected46 at risk EG00132 events22 affected46 at risk
Chest pain	General disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Edema limbs	General disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0017 events4 affected46 at risk
Fatigue	General disorders	MedDRA 9	Systematic Assessment	EG00025 events15 affected46 at risk EG00144 events19 affected46 at risk
Fever	General disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0013 events3 affected46 at risk
Pain	General disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Hypersensitivity	Immune system disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Biliary tract infection	Infections and infestations	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Gingival infection	Infections and infestations	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Infection	Infections and infestations	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0013 events1 affected46 at risk
Nail infection	Infections and infestations	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0012 events1 affected46 at risk
Paranasal sinus infection	Infections and infestations	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Pneumonia	Infections and infestations	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Sinusitis	Infections and infestations	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Skin infection	Infections and infestations	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0014 events4 affected46 at risk
Vaginal infection	Infections and infestations	MedDRA 9	Systematic Assessment	EG0002 events1 affected46 at risk EG0010 events0 affected46 at risk
Venous injury - Extremity-upper	Injury, poisoning and procedural complications	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Alanine aminotransferase increased	Investigations	MedDRA 9	Systematic Assessment	EG00012 events10 affected46 at risk EG00113 events7 affected46 at risk
Alkaline phosphatase increased	Investigations	MedDRA 9	Systematic Assessment	EG00015 events11 affected46 at risk EG00112 events10 affected46 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 9	Systematic Assessment	EG0005 events5 affected46 at risk EG00110 events10 affected46 at risk
Bilirubin increased	Investigations	MedDRA 9	Systematic Assessment	EG0003 events3 affected46 at risk EG0016 events5 affected46 at risk
Cardiac troponin T increased	Investigations	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Coagulopathy	Investigations	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Creatinine increased	Investigations	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
INR increased	Investigations	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0012 events1 affected46 at risk
Laboratory test abnormal	Investigations	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0012 events2 affected46 at risk
Leukocyte count decreased	Investigations	MedDRA 9	Systematic Assessment	EG00013 events7 affected46 at risk EG0017 events5 affected46 at risk
Lipase increased	Investigations	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Lymphocyte count decreased	Investigations	MedDRA 9	Systematic Assessment	EG0005 events4 affected46 at risk EG0019 events2 affected46 at risk
Neutrophil count decreased	Investigations	MedDRA 9	Systematic Assessment	EG00069 events25 affected46 at risk EG00145 events21 affected46 at risk
Platelet count decreased	Investigations	MedDRA 9	Systematic Assessment	EG00095 events32 affected46 at risk EG00173 events29 affected46 at risk
Weight loss	Investigations	MedDRA 9	Systematic Assessment	EG0007 events4 affected46 at risk EG00112 events5 affected46 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG00016 events12 affected46 at risk EG00130 events17 affected46 at risk
Blood glucose increased	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0003 events3 affected46 at risk EG0019 events7 affected46 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0014 events4 affected46 at risk
Serum albumin decreased	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0002 events2 affected46 at risk EG00117 events10 affected46 at risk
Serum calcium decreased	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG00113 events7 affected46 at risk
Serum calcium increased	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Serum glucose decreased	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Serum magnesium decreased	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0008 events5 affected46 at risk EG001102 events31 affected46 at risk
Serum phosphate decreased	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0012 events2 affected46 at risk
Serum potassium decreased	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0014 events4 affected46 at risk
Serum sodium decreased	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0007 events4 affected46 at risk EG0014 events3 affected46 at risk
Serum sodium increased	Metabolism and nutrition disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 9	Systematic Assessment	EG0002 events1 affected46 at risk EG0013 events3 affected46 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 9	Systematic Assessment	EG0002 events1 affected46 at risk EG0010 events0 affected46 at risk
Joint pain	Musculoskeletal and connective tissue disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Muscle weakness	Musculoskeletal and connective tissue disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0015 events4 affected46 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Mini mental status examination abnormal	Nervous system disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Taste alteration	Nervous system disorders	MedDRA 9	Systematic Assessment	EG0003 events3 affected46 at risk EG0015 events3 affected46 at risk
Confusion	Psychiatric disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Insomnia	Psychiatric disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0012 events2 affected46 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 9	Systematic Assessment	EG00022 events12 affected46 at risk EG00115 events12 affected46 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 9	Systematic Assessment	EG00019 events10 affected46 at risk EG00125 events14 affected46 at risk
Hiccough	Respiratory, thoracic and mediastinal disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0012 events1 affected46 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0012 events2 affected46 at risk
Pharyngeal examination abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0012 events1 affected46 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG00111 events5 affected46 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 9	Systematic Assessment	EG0002 events2 affected46 at risk EG0017 events5 affected46 at risk
Hand-and-foot syndrome	Skin and subcutaneous tissue disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected46 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 9	Systematic Assessment	EG00010 events5 affected46 at risk EG00120 events6 affected46 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 9	Systematic Assessment	EG00022 events13 affected46 at risk EG00178 events31 affected46 at risk
Rash desquamating	Skin and subcutaneous tissue disorders	MedDRA 9	Systematic Assessment	EG00090 events32 affected46 at risk EG001183 events43 affected46 at risk
Skin ulceration	Skin and subcutaneous tissue disorders	MedDRA 9	Systematic Assessment	EG0000 events0 affected46 at risk EG0013 events2 affected46 at risk
Phlebitis	Vascular disorders	MedDRA 9	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected46 at risk
Thrombosis	Vascular disorders	MedDRA 9	Systematic Assessment	EG0003 events3 affected46 at risk EG0016 events6 affected46 at risk

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D004700	Endocrine System Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
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
BG000	Arm A: GE	Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
BG001	Arm B: PGE	Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A: GE	Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.			30	46	45	46
EG001	Arm B: PGE	Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.			27	46	46	46

ID	Term
D000077544	Panitumumab
D000069347	Erlotinib Hydrochloride
D000093542	Gemcitabine