A Study of Tarceva (Erlotinib) in Combination With Gemcit... | NCT00461708

Label	Type	Description	Intervention Names
Rash, Grade <2	Experimental	Participants with a rash graded less than (<) 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (v.) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg per (/) square meter (m^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.	Drug: Erlotinib Drug: Gemcitabine
Rash, Grade ≥2	Experimental	Participants with a rash graded greater than or equal to (≥) 2 according to the NCI-CTC v. 3.0 received erlotinib, 100 mg, PO, once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.	Drug: Erlotinib Drug: Gemcitabine

Name	Type	Description	Arm Group Labels	Other Names
Erlotinib	Drug	100 mg, PO, once per day	Rash, Grade <2 Rash, Grade ≥2

Measure	Description	Time Frame
Number of Participants Who Died During the Study		Enrollment through Cycle 24 (4-week cycles), up to 24 months.
Overall Survival (OS) During the Study	OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.	Enrollment through Cycle 24 (4-week cycles), up to 24 months.

Measure	Description	Time Frame
Number of Participants Who Died at 6 Months		Enrollment through Cycle 6 (4-week cycles), up to 6 months.
OS At 6 Months	OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

ID	Title	Description
FG000	Erlotinib, Gemcitabine: Rash Grade Less Than (<) 2	Participants with a rash Grade < 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (V) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.

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

Number of Participants Who Died During the Study

ITT population

Posted

Number

participants

Enrollment through Cycle 24 (4-week cycles), up to 24 months.

ID	Title	Description
OG000	Erlotinib, Gemcitabine: Rash Grade < 2	Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
OG001	Erlotinib, Gemcitabine: Rash Grade ≥ 2	Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.

Units	Counts
Participants	OG000115 OG00138

Title

Denominators

Categories

Title	Measurements
	OG000102 OG00127

Primary

Overall Survival (OS) During the Study

OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.

ITT population; only participants who died were included in the analysis.

Posted

Median

95% Confidence Interval

months

Enrollment through Cycle 24 (4-week cycles), up to 24 months.

ID	Title	Description
OG000	Erlotinib, Gemcitabine: Rash Grade < 2	Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
OG001	Erlotinib, Gemcitabine: Rash Grade ≥ 2	Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.

Secondary

Number of Participants Who Died at 6 Months

ITT population

Posted

Number

participants

Enrollment through Cycle 6 (4-week cycles), up to 6 months.

ID	Title	Description
OG000	Erlotinib, Gemcitabine: Rash Grade < 2	Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
OG001	Erlotinib, Gemcitabine: Rash Grade ≥ 2	Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.

Secondary

OS At 6 Months

ITT population; only participants who died were included in the analysis.

Posted

Median

95% Confidence Interval

months

Enrollment through Cycle 6 (4-week cycles), up to 6 months.

ID	Title	Description
OG000	Erlotinib, Gemcitabine: Rash Grade < 2	Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
OG001	Erlotinib, Gemcitabine: Rash Grade ≥ 2	Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.

Secondary

Number of Participants Who Died During the Study By Rash Grade

ITT population

Posted

Number

participants

Enrollment through Cycle 24 (4-week cycles), up to 24 months.

ID	Title	Description
OG000	Erlotinib, Gemcitabine: Rash Grade 0	Participants with a rash Grade 0 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
OG001	Erlotinib, Gemcitabine: Rash Grade 1	Participants with a rash Grade 1 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
OG002	Erlotinib, Gemcitabine: Rash Grade ≥ 2

Secondary

OS By Rash Grade

ITT population; only participants who died were included in the analysis.

Posted

Median

95% Confidence Interval

months

Enrollment through Cycle 24 (4-week cycles), up to 24 months.

ID	Title	Description
OG000	Erlotinib, Gemcitabine: Rash Grade 0	Participants with a rash Grade 0 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
OG001	Erlotinib, Gemcitabine: Rash Grade 1	Participants with a rash Grade 1 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.

Secondary

Number of Participants With Disease Progression or Death

Progression-free survival (PFS) was defined as the time from the date of enrollment to the date of document disease progression or death due to any cause. As per Response Evaluation Criteria in Solid Tumors (RECIST) V 1.0, progressive disease (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 whose last recorded status was not PD or death were censored.

ITT population

Posted

Number

participants

Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.

ID	Title	Description
OG000	Erlotinib, Gemcitabine: Rash Grade < 2	Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
OG001	Erlotinib, Gemcitabine: Rash Grade ≥ 2	Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.

Secondary

PFS

The time, in months, from enrollment to PFS event. Participants whose last recorded status was not progression or death were censored. PFS was estimated using Kaplan-Meier methodology.

ITT population; only participants with an event (death or disease progression) were included in the analysis.

Posted

Median

95% Confidence Interval

months

Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months

ID	Title	Description
OG000	Erlotinib, Gemcitabine: Rash Grade < 2	Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
OG001	Erlotinib, Gemcitabine: Rash Grade ≥ 2	Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.

Secondary

Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST

As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.

ITT population

Posted

Number

percentage of participants

Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.

ID	Title	Description
OG000	Erlotinib, Gemcitabine: Rash Grade < 2	Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
OG001	Erlotinib, Gemcitabine: Rash Grade ≥ 2	Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.

Secondary

Percentage of Participants With Disease Control According to RECIST

Disease control was defined as BOR of CR, PR, or stable disease (SD). As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.

ITT population

Posted

Number

percentage of participants

Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.

ID	Title	Description
OG000	Erlotinib, Gemcitabine: Rash Grade < 2	Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Haemorrhage, GI	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0011 affected38 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0011 affected38 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0010 affected38 at risk
Benign prostatic hyperplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Gastrointestinal toxicity	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Calcium, serum-low (hypocalcemia)	Metabolism and nutrition disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Anaemia	Blood and lymphatic system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Back pain	Musculoskeletal and connective tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Pericardial effusion	Cardiac disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Vomiting	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0010 affected38 at risk
Sudden death	General disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Bilirubin (Hyperbilirubinemia)	Hepatobiliary disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Haemorrhage, rectal	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Liver	Surgical and medical procedures	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Myelosuppression	Blood and lymphatic system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Thrombocytopenia	Blood and lymphatic system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Cardiac failure congestive	Cardiac disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Hypertension	Vascular disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Left ventricular dysfunction	Cardiac disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Valvular heart disease	Cardiac disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Fatigue	General disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0004 affected115 at risk EG0011 affected38 at risk
Fever	General disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0004 affected115 at risk EG0012 affected38 at risk
Weight loss	Investigations	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Diarrhea	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Gastrointestinal syndrome	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Obstruction, GI	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00011 affected115 at risk EG0012 affected38 at risk
Perforation, GI	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Visceral arterial ischemia	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Haemorrhage, CNS	Nervous system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Liver dysfunction	Hepatobiliary disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Liver dysfunction/failure	Hepatobiliary disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Pancreatitis	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0011 affected38 at risk
Anal/perianal	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Blood	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0004 affected115 at risk EG0012 affected38 at risk
Cellulitis	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Lung (pneumonia)	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0013 affected38 at risk
Peritoneal cavity	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0011 affected38 at risk
Upper airway nos	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Urinary tract nos	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Glucose, serum-high (hyperglycemia)	Metabolism and nutrition disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
CNS Cerebrovascular ischemia	Nervous system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0012 affected38 at risk
Confusion	Psychiatric disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Speech impairment	Nervous system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Abdomen nos	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0005 affected115 at risk EG0010 affected38 at risk
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Obstruction, GU	Renal and urinary disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Renal failure	Renal and urinary disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Thrombosis/Embolism	Vascular disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0011 affected38 at risk
Thrombosis/Thrombus	Vascular disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0010 affected38 at risk
Visceral arterial ischemia	Vascular disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Pain	General disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Diabetes	Metabolism and nutrition disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0010 affected38 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00043 affected115 at risk EG00112 affected38 at risk
Constipation	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00038 affected115 at risk EG00112 affected38 at risk
Vomiting	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00034 affected115 at risk EG0018 affected38 at risk
Neutropenia	Blood and lymphatic system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00020 affected115 at risk EG00116 affected38 at risk
Anorexia	Metabolism and nutrition disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00062 affected115 at risk EG00111 affected38 at risk
Weight loss	Investigations	NCI-CTC V 3.0	Non-systematic Assessment	EG00027 affected115 at risk EG0015 affected38 at risk
Fever	General disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00018 affected115 at risk EG00111 affected38 at risk
Fatigue	General disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00089 affected115 at risk EG00131 affected38 at risk
Dysgeusia	Nervous system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0004 affected115 at risk EG0015 affected38 at risk
Ascites	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0007 affected115 at risk EG0012 affected38 at risk
Insomnia	Psychiatric disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0004 affected115 at risk EG0012 affected38 at risk
Flatulence	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0012 affected38 at risk
Cataract	Eye disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Confusion	Psychiatric disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Muscle weakness	Musculoskeletal and connective tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0011 affected38 at risk
Oral cavity	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Esophagitis	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0011 affected38 at risk
Hypertension	Vascular disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0011 affected38 at risk
Pulmonary hypertension	Vascular disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Myelitis	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Rhinitis	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0011 affected38 at risk
Tremor	Nervous system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0010 affected38 at risk
Arthritis	Musculoskeletal and connective tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Dysphagia	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0010 affected38 at risk
Gastritis	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0010 affected38 at risk
Lymphopenia	Blood and lymphatic system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0010 affected38 at risk
Neuropathy	Nervous system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0006 affected115 at risk EG0011 affected38 at risk
Obesity	Metabolism and nutrition disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0010 affected38 at risk
Eyelid dysfunction	Eye disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Ocular surface disease	Eye disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Chills	General disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Atrial fibrillation	Cardiac disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Haematoma	Vascular disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Hypotension	Vascular disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Monocytopenia	Blood and lymphatic system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Proctitis	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Allergic reaction	Immune system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Thrombocytosis	Blood and lymphatic system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Vision - Blurred vision	Eye disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Allergy /immunology- other	Immune system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0010 affected38 at risk
Hearing loss	Ear and labyrinth disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Anaemia	Blood and lymphatic system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00032 affected115 at risk EG00111 affected38 at risk
Granulocytopenia	Blood and lymphatic system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Hemoglobin	Blood and lymphatic system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0011 affected38 at risk
Hemorrhage	Blood and lymphatic system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Leukocytes	Blood and lymphatic system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Leukocytosis	Blood and lymphatic system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0010 affected38 at risk
Leukopenia	Blood and lymphatic system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0008 affected115 at risk EG0013 affected38 at risk
Left ventricular dysfunction	Cardiac disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0012 affected38 at risk
Constitutional symptoms- other	General disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00011 affected115 at risk EG0016 affected38 at risk
Sweating	Metabolism and nutrition disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Alopecia	Skin and subcutaneous tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Cheilitis	Skin and subcutaneous tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Dermatology/skin- other	Skin and subcutaneous tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0011 affected38 at risk
Dry skin	Skin and subcutaneous tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Hypopigmentation	Skin and subcutaneous tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Nail changes	Skin and subcutaneous tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0010 affected38 at risk
Pruritus/itching	Skin and subcutaneous tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0010 affected38 at risk
Rash/desquamation	Skin and subcutaneous tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0011 affected38 at risk
Diabetes	Metabolism and nutrition disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0011 affected38 at risk
Endocrine- other	Endocrine disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Diarrhea	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00055 affected115 at risk EG00115 affected38 at risk
Gastrointestinal - other	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00021 affected115 at risk EG0015 affected38 at risk
Gastrointestinal toxicity	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Heartburn/dyspepsia	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00013 affected115 at risk EG0013 affected38 at risk
Hemorrhoids	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0011 affected38 at risk
Mucositis/stomatitis	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00019 affected115 at risk EG0019 affected38 at risk
Obstruction, GI	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0011 affected38 at risk
Perforation, GI	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Periodontal disease	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Xerostomia	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0006 affected115 at risk EG0012 affected38 at risk
Anal haemorrhage	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Hemorrhage nasal	Respiratory, thoracic and mediastinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0011 affected38 at risk
Hemorrhage rectal	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Liver dysfunction	Hepatobiliary disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0008 affected115 at risk EG0013 affected38 at risk
Pancreas, exocrine	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0010 affected38 at risk
Abdomen nos	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Anal/perianal	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Blood	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0011 affected38 at risk
Conjunctiva	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0005 affected115 at risk EG0010 affected38 at risk
Infection	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Lung (Pneumonia)	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0011 affected38 at risk
Middle ear	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Oral cavity-gums	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0010 affected38 at risk
Skin	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0010 affected38 at risk
Soft tissue nos	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Upper airway nos	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0006 affected115 at risk EG0013 affected38 at risk
Urinary tract nos	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0011 affected38 at risk
Edema	Blood and lymphatic system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00011 affected115 at risk EG0013 affected38 at risk
Edema: limb	Blood and lymphatic system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00022 affected115 at risk EG0012 affected38 at risk
Lymphatics- other	Blood and lymphatic system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Albumin, serum-low	Metabolism and nutrition disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Alkaline phosphatase	Investigations	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0010 affected38 at risk
ALT, SGPT	Investigations	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0011 affected38 at risk
ALT, SGPT	Investigations	NCI-CTC V 3.0	Non-systematic Assessment	EG0004 affected115 at risk EG0012 affected38 at risk
Bilirubin	Hepatobiliary disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0004 affected115 at risk EG0014 affected38 at risk
Calcium, serum high	Metabolism and nutrition disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0004 affected115 at risk EG0011 affected38 at risk
GGT (Gamma-glutamyl)	Investigations	NCI-CTC V 3.0	Non-systematic Assessment	EG0005 affected115 at risk EG0011 affected38 at risk
Glucose, serum high	Metabolism and nutrition disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0006 affected115 at risk EG0011 affected38 at risk
Glucose, serum low	Metabolism and nutrition disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0005 affected115 at risk EG0011 affected38 at risk
Hypercreatinaemia	Metabolism and nutrition disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Magnesium, serum low	Metabolism and nutrition disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0011 affected38 at risk
Metabolic/laboratory	Metabolism and nutrition disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0011 affected38 at risk
Potassium, serum high	Metabolism and nutrition disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0011 affected38 at risk
Potassium, serum low	Metabolism and nutrition disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0010 affected38 at risk
Dizziness	Nervous system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0012 affected38 at risk
Extrapyramidal	Nervous system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Personality/behavioral	Psychiatric disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00019 affected115 at risk EG0012 affected38 at risk
Somnolence	Nervous system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0004 affected115 at risk EG0010 affected38 at risk
Other	General disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Abdomen nos	Musculoskeletal and connective tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00078 affected115 at risk EG00119 affected38 at risk
Back	Musculoskeletal and connective tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0009 affected115 at risk EG0017 affected38 at risk
Bone	Musculoskeletal and connective tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0004 affected115 at risk EG0010 affected38 at risk
Chest/thorax nos	General disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0010 affected38 at risk
Genitourinary	Renal and urinary disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Headache	Nervous system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0006 affected115 at risk EG0011 affected38 at risk
Joint	Musculoskeletal and connective tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0010 affected38 at risk
Kidney	Renal and urinary disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Muscle	Musculoskeletal and connective tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0005 affected115 at risk EG0016 affected38 at risk
Neck	Musculoskeletal and connective tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Neck/back	Musculoskeletal and connective tissue disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Pain	General disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00018 affected115 at risk EG0018 affected38 at risk
Peritoneum	General disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Skin	General disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	NCI-CTC V 3.0	Non-systematic Assessment	EG0004 affected115 at risk EG0012 affected38 at risk
Nasal/ paranasal	General disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0011 affected38 at risk
Nasal/paranasal reactions	Respiratory, thoracic and mediastinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0006 affected115 at risk EG0014 affected38 at risk
Cough	Respiratory, thoracic and mediastinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00012 affected115 at risk EG0014 affected38 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00011 affected115 at risk EG0015 affected38 at risk
Hiccoughs	Respiratory, thoracic and mediastinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Pulmonay/upper respiratoy- other	Respiratory, thoracic and mediastinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Voice changes	Respiratory, thoracic and mediastinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0011 affected38 at risk
Cystitis	Infections and infestations	NCI-CTC V 3.0	Non-systematic Assessment	EG0006 affected115 at risk EG0012 affected38 at risk
Incontinence, urinary	Renal and urinary disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Renal failure	Renal and urinary disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0004 affected115 at risk EG0011 affected38 at risk
Renal/genitourinary	Renal and urinary disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Testicular oedema	Reproductive system and breast disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Urinary retention	Renal and urinary disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0010 affected38 at risk
Urine color change	Renal and urinary disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0006 affected115 at risk EG0010 affected38 at risk
Upper airway nos	Surgical and medical procedures	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Vein nos	Surgical and medical procedures	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Phlebitis	Vascular disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0005 affected115 at risk EG0014 affected38 at risk
Thrombosis/embolism	Vascular disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0007 affected115 at risk EG0015 affected38 at risk
Thrombosis/thrombus	Vascular disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0004 affected115 at risk EG0010 affected38 at risk
Vein injury	Vascular disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0000 affected115 at risk EG0011 affected38 at risk
Distension/bloating	Gastrointestinal disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0003 affected115 at risk EG0013 affected38 at risk
Fracture	Injury, poisoning and procedural complications	NCI-CTC V 3.0	Non-systematic Assessment	EG0001 affected115 at risk EG0010 affected38 at risk
Ocular/visual- other	Eye disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG0002 affected115 at risk EG0010 affected38 at risk
Thrombopenia	Blood and lymphatic system disorders	NCI-CTC V 3.0	Non-systematic Assessment	EG00021 affected115 at risk EG00110 affected38 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Alcoy	Alicante	03804	Spain

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
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	Erlotinib, Gemcitabine: Rash Grade < 2	Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
BG001	Erlotinib, Gemcitabine: Rash Grade ≥ 2	Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
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	Erlotinib, Gemcitabine: Rash Grade < 2	Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.			58	115	115	115
EG001	Erlotinib, Gemcitabine: Rash Grade ≥ 2	Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.			14	38	38	38