An Observational Study of Erlotinib Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01782690
• Collaborator: (none)
• Enrollment: 338
• Location: 1
• Duration (Months): 35
• Patients Per Site Per Month: 9.7

Study Details

Study Description

Brief Summary

This observational study will evaluate the impact of rash on survival of patients with metastatic pancreatic cancer treated with erlotinib plus gemcitabine. Further, clinical effectiveness, efficacy and safety will be assessed. Data will be collected for 12 months.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: erlotinib; Drug: gemcitabine

Study Design

• Study Type: Observational
• Actual Enrollment: 338 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impact on Survival of Cutaneous Reactions in Erlotinib Plus Gemcitabine Treated Patients With Metastatic Pancreatic Cancer Under Conditions of Daily Routine Practice
• Study Start Date: Mar 31, 2012
• Actual Primary Completion Date: Feb 28, 2015
• Actual Study Completion Date: Feb 28, 2015

Arms and Interventions

Arm	Intervention/Treatment
Erlotinib plus Gemcitabine Patients with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.	Drug: erlotinib; Study participants will receive erlotinib according to Summary of Product Characteristics (SmPC); Other Names: Tarceva ; Drug: gemcitabine; Study participants will receive gemcitabine according to Summary of Product Characteristics (SmPC)

Outcome Measures

Primary Outcome Measures

1. Overall Survival Stratified by Rash [Up to 12 months]

   Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by rash status. Participants with rash: rash = yes. Participants without rash: rash = no.

Secondary Outcome Measures

1. Number of Participants With Rash by Severity [Up to 12 months]

   Reported is the total number of participants with rash as well as the number of participants with specific forms of rash, including paronychia, dry skin and papulopustulous eczema. Severity was reported according to Common Terminology Criteria for Adverse Events version 4.0 (CTC AE 4.0): Grade 1 = mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 = moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.

2. Number of Participants With Adverse Events (AEs) [Up to 12 months]

   An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

3. Number of Dose Modifications and Dose Withdrawals of Erlotinib [Up to 12 months]

   Reported is the total number of dose modifications/withdrawals for erlotinib.

4. Number of Dose Modifications and Dose Withdrawals of Gemcitabine [Up to 12 months]

   Reported is the number of dose modifications/withdrawals for gemcitabine.

5. Time of Onset of Rash After Start Erlotinib Treatment [Up to 12 months]

   Reported is the number of days from first erlotinib treatment to first rash onset.

6. Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS) [Up to 12 months]

   Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by ECOG-PS at baseline (0-1 versus 2). ECOG-PS 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG-PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. ECOPG-PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.

7. Percentage of Participants With Best Overall Response [Up to 12 months]

   Best overall response was defined as complete response (CR) plus partial response (PR). Tumor evaluations were performed in accordance with daily routine practice.

8. Time to Disease Progression [Up to 12 months]

   Disease progression was defined in accordance with daily routine practice.

9. Score in Patient Questionnaire: Possible Side Effects [At Weeks 4, 8, 9 and 16]

   Participant questionnaire regarding satisfaction with the information about possible side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study.

10. Score in Participant Questionnaire: What to Do in Case of Side Effect [At Weeks 4, 8, 9 and 16]

    Participant questionnaire regarding satisfaction with the information about what one should do in case of side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study.

11. Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation [At Weeks 4, 8, 9 and 16]

    Participant questionnaire regarding the actual side effects of therapy compared to what one expected before therapy. Assessment ranged from 1 (less than expected) to 6 (more than expected). Questionnaire scores were assessed at several time points during the study.

12. Score in Participant Questionnaire: Quality of Life [At Weeks 4, 8, 9 and 16]

    Participant assessment of life quality under therapy. Assessment ranged from 1 (very good) to 6 (very bad). Questionnaire scores were assessed at several time points during the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adults, age >= 18 years

• Patients with metastatic pancreatic cancer where investigators have decided to give combination therapy of erlotinib and gemcitabine according to Summary of Product Characteristics (SmPC)

Exclusion Criteria:

• Contraindications for erlotinib according to Summary of Products Characteristics (SmPC)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinikum der Universität zu Köln Klinik für Gastroenterologie am Abdominalzentrum	Köln		Germany	50937

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01782690
• Other Study ID Numbers: ML23024
• First Posted: Feb 4, 2013
• Last Update Posted: Jul 23, 2018
• Last Verified: Oct 1, 2017

• Additional relevant MeSH terms: Pancreatic Neoplasms; Gemcitabine; Erlotinib Hydrochloride

Study Results

Participant Flow

Arm/Group Title	Erlotinib Plus Gemcitabine
Arm/Group Description	Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
Period Title: Overall Study
STARTED	338
COMPLETED	39
NOT COMPLETED	299

Baseline Characteristics

Arm/Group Title	Erlotinib Plus Gemcitabine
Arm/Group Description	Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
Overall Participants	338
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.9 (9.1)
Sex: Female, Male (Count of Participants)
Female	135 39.9%
Male	203 60.1%

Outcome Measures

1. Primary Outcome

Title	Overall Survival Stratified by Rash
Description	Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by rash status. Participants with rash: rash = yes. Participants without rash: rash = no.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.

Arm/Group Title	Erlotinib Plus Gemcitabine
Arm/Group Description	Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
Measure Participants	270
Rash = Yes	9.9288 (0.5066)
Rash = No	8.6795 (0.3151)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Erlotinib Plus Gemcitabine
	Comments	Comparison of Rash=Yes versus Rash=No within Erlotinib plus Gemcitabine arm
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2361
	Comments
	Method	Log Rank
	Comments

2. Secondary Outcome

Title	Number of Participants With Rash by Severity
Description	Reported is the total number of participants with rash as well as the number of participants with specific forms of rash, including paronychia, dry skin and papulopustulous eczema. Severity was reported according to Common Terminology Criteria for Adverse Events version 4.0 (CTC AE 4.0): Grade 1 = mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 = moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least one treatment with study medication.

Arm/Group Title	Erlotinib Plus Gemcitabine
Arm/Group Description	Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
Measure Participants	338
Total number with rash	174 51.5%
Paronychia Grade 1	10 3%
Paronychia Grade 2	7 2.1%
Paronychia Grade 3	2 0.6%
Dry skin Grade 1	62 18.3%
Dry skin Grade 2	26 7.7%
Papulopustulous eczema Grade 1	89 26.3%
Papulopustulous eczema Grade 2	69 20.4%
Papulopustulous eczema Grade 3	6 1.8%

3. Secondary Outcome

Title	Number of Participants With Adverse Events (AEs)
Description	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least one treatment with study medication.

Arm/Group Title	Erlotinib Plus Gemcitabine
Arm/Group Description	Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
Measure Participants	338
Number [participants]	310 91.7%

4. Secondary Outcome

Title	Number of Dose Modifications and Dose Withdrawals of Erlotinib
Description	Reported is the total number of dose modifications/withdrawals for erlotinib.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least one treatment with study medication

Arm/Group Title	Erlotinib Plus Gemcitabine
Arm/Group Description	Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
Measure Participants	338
Number [dose modifications/withdrawals]	152

5. Secondary Outcome

Title	Number of Dose Modifications and Dose Withdrawals of Gemcitabine
Description	Reported is the number of dose modifications/withdrawals for gemcitabine.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least one treatment with study medication

Arm/Group Title	Erlotinib Plus Gemcitabine
Arm/Group Description	Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
Measure Participants	338
Number [dose modifications/withdrawals]	738

6. Secondary Outcome

Title	Time of Onset of Rash After Start Erlotinib Treatment
Description	Reported is the number of days from first erlotinib treatment to first rash onset.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least one treatment with study medication.

Arm/Group Title	Erlotinib Plus Gemcitabine
Arm/Group Description	Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
Measure Participants	338
Mean (Standard Deviation) [days]	18.4 (21.6)

7. Secondary Outcome

Title	Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Description	Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by ECOG-PS at baseline (0-1 versus 2). ECOG-PS 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG-PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. ECOPG-PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.

Arm/Group Title	Erlotinib Plus Gemcitabine
Arm/Group Description	Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
Measure Participants	270
ECOG-PS grade 0-1	9.8301 (0.3726)
ECOG-PS grade 2	6.3452 (0.7396)

8. Secondary Outcome

Title	Percentage of Participants With Best Overall Response
Description	Best overall response was defined as complete response (CR) plus partial response (PR). Tumor evaluations were performed in accordance with daily routine practice.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.

Arm/Group Title	Erlotinib Plus Gemcitabine
Arm/Group Description	Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
Measure Participants	270
Number [percentage of participants]	24.74 7.3%

9. Secondary Outcome

Title	Time to Disease Progression
Description	Disease progression was defined in accordance with daily routine practice.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.

Arm/Group Title	Erlotinib Plus Gemcitabine
Arm/Group Description	Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
Measure Participants	270
Median (95% Confidence Interval) [months]	4.3726 (0.2945)

10. Secondary Outcome

Title	Score in Patient Questionnaire: Possible Side Effects
Description	Participant questionnaire regarding satisfaction with the information about possible side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study.
Time Frame	At Weeks 4, 8, 9 and 16

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least one treatment with study medication.

Arm/Group Title	Erlotinib Plus Gemcitabine
Arm/Group Description	Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
Measure Participants	338
Week 4	1.9 (0.9)
Week 8	1.9 (0.9)
Week 9	1.0 (NA)
Week 16	1.9 (0.9)

11. Secondary Outcome

Title	Score in Participant Questionnaire: What to Do in Case of Side Effect
Description	Participant questionnaire regarding satisfaction with the information about what one should do in case of side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study.
Time Frame	At Weeks 4, 8, 9 and 16

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least one treatment with study medication.

Arm/Group Title	Erlotinib Plus Gemcitabine
Arm/Group Description	Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
Measure Participants	338
Week 4	1.9 (0.8)
Week 8	2.0 (1.0)
Week 9	1.0 (NA)
Week 16	1.9 (0.7)

12. Secondary Outcome

Title	Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation
Description	Participant questionnaire regarding the actual side effects of therapy compared to what one expected before therapy. Assessment ranged from 1 (less than expected) to 6 (more than expected). Questionnaire scores were assessed at several time points during the study.
Time Frame	At Weeks 4, 8, 9 and 16

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least one treatment with study medication.

Arm/Group Title	Erlotinib Plus Gemcitabine
Arm/Group Description	Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
Measure Participants	338
Week 4	2.6 (1.1)
Week 8	2.6 (1.1)
Week 9	6.0 (NA)
Week 16	2.7 (1.1)

13. Secondary Outcome

Title	Score in Participant Questionnaire: Quality of Life
Description	Participant assessment of life quality under therapy. Assessment ranged from 1 (very good) to 6 (very bad). Questionnaire scores were assessed at several time points during the study.
Time Frame	At Weeks 4, 8, 9 and 16

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least one treatment with study medication.

Arm/Group Title	Erlotinib Plus Gemcitabine
Arm/Group Description	Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
Measure Participants	338
Week 4	2.9 (1.1)
Week 8	2.9 (1.2)
Week 9	1.0 (NA)
Week 16	2.9 (1.1)

Adverse Events

Time Frame	Up to 12 months
Adverse Event Reporting Description	Safety population included all participants who received at least one treatment with study medication.
Arm/Group Title	Erlotinib Plus Gemcitabine
Arm/Group Description	Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
All Cause Mortality
	Erlotinib Plus Gemcitabine
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Erlotinib Plus Gemcitabine
	Affected / at Risk (%)	# Events
Total	171/338 (50.6%)
Blood and lymphatic system disorders
Anaemia	6/338 (1.8%)
Anaemia of malignant disease	1/338 (0.3%)
Febrile neutropenia	1/338 (0.3%)
Leukopenia	3/338 (0.9%)
Neutropenia	3/338 (0.9%)
Thrombocytopenia	1/338 (0.3%)
Cardiac disorders
Atrial fibrillation	1/338 (0.3%)
Cardiac arrest	1/338 (0.3%)
Cardiac failure	2/338 (0.6%)
Congenital, familial and genetic disorders
Pyloric stenosis	1/338 (0.3%)
Eye disorders
Ocular icterus	1/338 (0.3%)
Gastrointestinal disorders
Abdominal distension	1/338 (0.3%)
Abdominal pain	6/338 (1.8%)
Abdominal pain upper	5/338 (1.5%)
Ascites	8/338 (2.4%)
Constipation	3/338 (0.9%)
Diarrhoea	4/338 (1.2%)
Duodenal ulcer	1/338 (0.3%)
Functional gastrointestinal disorder	1/338 (0.3%)
Gastric stenosis	1/338 (0.3%)
Gastric varices haemorrhage	1/338 (0.3%)
Gastritis	1/338 (0.3%)
Gastritis haemorrhagic	2/338 (0.6%)
Gastrointestinal haemorrhage	4/338 (1.2%)
Gastrointestinal ulcer haemorrhage	1/338 (0.3%)
Gastrooesophageal reflux disease	2/338 (0.6%)
Haematemesis	2/338 (0.6%)
Ileus	4/338 (1.2%)
Impaired gastric emptying	1/338 (0.3%)
Mechanical ileus	1/338 (0.3%)
Melaena	1/338 (0.3%)
Nausea	9/338 (2.7%)
Pancreatitis	1/338 (0.3%)
Subileus	1/338 (0.3%)
Upper gastrointestinal haemorrhage	7/338 (2.1%)
Vomiting	7/338 (2.1%)
General disorders
Adverse event	1/338 (0.3%)
Asthenia	4/338 (1.2%)
Chills	3/338 (0.9%)
Death	9/338 (2.7%)
Device dislocation	2/338 (0.6%)
Device occlusion	6/338 (1.8%)
Disease progression	6/338 (1.8%)
Fatigue	2/338 (0.6%)
General physical health deterioration	41/338 (12.1%)
Oedema peripheral	1/338 (0.3%)
Pain	9/338 (2.7%)
Performance status decreased	1/338 (0.3%)
Peripheral swelling	2/338 (0.6%)
Pyrexia	9/338 (2.7%)
Stent malfunction	1/338 (0.3%)
Ulcer	1/338 (0.3%)
Ulcer haemorrhage	1/338 (0.3%)
Hepatobiliary disorders
Bile duct obstruction	2/338 (0.6%)
Bile duct stenosis	1/338 (0.3%)
Cholangitis	14/338 (4.1%)
Cholecystitis acute	2/338 (0.6%)
Cholestatis	8/338 (2.4%)
Hepatic failure	2/338 (0.6%)
Hydrocholecystis	1/338 (0.3%)
Jaundice	8/338 (2.4%)
Jaundice extrahepatic obstructive	1/338 (0.3%)
Infections and infestations
Bronchitis	1/338 (0.3%)
Bronchopneumonia	1/338 (0.3%)
Cholangitis infective	1/338 (0.3%)
Cystitis	1/338 (0.3%)
Device related infection	3/338 (0.9%)
Diverticulitis	1/338 (0.3%)
Endocarditis	1/338 (0.3%)
Endophthalmitis	1/338 (0.3%)
Erysipelas	3/338 (0.9%)
Escherichia infection	3/338 (0.9%)
Infection	10/338 (3%)
Infective exacerbation of chronic obstructive airways disease	1/338 (0.3%)
Lobar pneumonia	1/338 (0.3%)
Pneumonia	9/338 (2.7%)
Pulmonary sepsis	2/338 (0.6%)
Sepsis	3/338 (0.9%)
Streptococcal sepsis	1/338 (0.3%)
Urinary tract infection	1/338 (0.3%)
Urosepsis	1/338 (0.3%)
Injury, poisoning and procedural complications
Biliary anastomosis complication	1/338 (0.3%)
Femoral neck fracture	1/338 (0.3%)
Procedural pain	1/338 (0.3%)
Investigations
Blood alkaline phosphatase abnormal	1/338 (0.3%)
Blood bilirubin abnormal	2/338 (0.6%)
Blood bilirubin increased	3/338 (0.9%)
Blood creatinine increased	1/338 (0.3%)
Blood glucose increased	1/338 (0.3%)
Body temperature increased	1/338 (0.3%)
Haemoglobin abnormal	2/338 (0.6%)
Haemoglobin decreased	2/338 (0.6%)
Neutrophil count decreased	1/338 (0.3%)
Platelet count decreased	1/338 (0.3%)
Weight decreased	1/338 (0.3%)
White blood cell count abnormal	1/338 (0.3%)
White blood cell count decreased	2/338 (0.6%)
White blood cell count increased	1/338 (0.3%)
Metabolism and nutrition disorders
Cachexia	1/338 (0.3%)
Decreased appetite	3/338 (0.9%)
Dehydration	2/338 (0.6%)
Diabetes mellitus	1/338 (0.3%)
Diet refusal	1/338 (0.3%)
Malnutrition	1/338 (0.3%)
Musculoskeletal and connective tissue disorders
Bursitis	1/338 (0.3%)
Intervertebral disc protrusion	1/338 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression	58/338 (17.2%)
Metastases to liver	1/338 (0.3%)
Metastases to lung	1/338 (0.3%)
Metastases to peritoneum	2/338 (0.6%)
Metastasis	1/338 (0.3%)
Neoplasm	1/338 (0.3%)
Pancreatic carcinoma	2/338 (0.6%)
Paraneoplastic syndrome	1/338 (0.3%)
Tumour compression	1/338 (0.3%)
Tumour invasion	1/338 (0.3%)
Nervous system disorders
Altered state of consciousness	1/338 (0.3%)
Aphasia	1/338 (0.3%)
Cerebral infarction	1/338 (0.3%)
Cerebral ischaemia	2/338 (0.6%)
Cerebrovascular accident	1/338 (0.3%)
Disturbance in attention	1/338 (0.3%)
Embolic cerebral infarction	1/338 (0.3%)
Hemiplegia	1/338 (0.3%)
Hypoaesthesia	1/338 (0.3%)
IIIrd nerve disorder	1/338 (0.3%)
Post herpetic neuralgia	1/338 (0.3%)
Sensory disturbance	1/338 (0.3%)
VIth nerve paralysis	1/338 (0.3%)
Psychiatric disorders
Disorientation	1/338 (0.3%)
Personality change	1/338 (0.3%)
Restlessness	1/338 (0.3%)
Renal and urinary disorders
Dysuria	1/338 (0.3%)
Haematuria	1/338 (0.3%)
Pollakiuria	1/338 (0.3%)
Renal failure	2/338 (0.6%)
Renal failure acute	2/338 (0.6%)
Urinary retention	1/338 (0.3%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	1/338 (0.3%)
Alveolitis	1/338 (0.3%)
Atelectasis	1/338 (0.3%)
Dyspnoea	8/338 (2.4%)
Epistaxis	1/338 (0.3%)
Pleural effusion	5/338 (1.5%)
Pneumonia aspiration	1/338 (0.3%)
Pneumothorax	1/338 (0.3%)
Pulmonary embolism	5/338 (1.5%)
Respiratory failure	1/338 (0.3%)
Skin and subcutaneous tissue disorders
Rash	4/338 (1.2%)
Skin hyperpigmentation	1/338 (0.3%)
Skin ulcer	1/338 (0.3%)
Surgical and medical procedures
Bile duct stent insertion	1/338 (0.3%)
Vascular disorders
Deep vein thrombosis	2/338 (0.6%)
Embolism	1/338 (0.3%)
Hypertensive crisis	1/338 (0.3%)
Infarction	1/338 (0.3%)
Thrombophlebitis	1/338 (0.3%)
Thrombosis	2/338 (0.6%)
Trousseau's syndrome	1/338 (0.3%)
Varicose vein	1/338 (0.3%)
Vena cava thrombosis	1/338 (0.3%)
Venous thrombosis limb	3/338 (0.9%)
Other (Not Including Serious) Adverse Events
	Erlotinib Plus Gemcitabine
	Affected / at Risk (%)	# Events
Total	261/338 (77.2%)
Gastrointestinal disorders
Constipation	19/338 (5.6%)
Diarrhoea	48/338 (14.2%)
Nausea	66/338 (19.5%)
Vomiting	20/338 (5.9%)
General disorders
Fatigue	49/338 (14.5%)
Oedema peripheral	26/338 (7.7%)
Pain	61/338 (18%)
Infections and infestations
Infection	23/338 (6.8%)
Investigations
Haemoglobin abnormal	35/338 (10.4%)
Platelet count abnormal	38/338 (11.2%)
White blood cell count abnormal	40/338 (11.8%)
Metabolism and nutrition disorders
Decreased appetite	24/338 (7.1%)
Skin and subcutaneous tissue disorders
Rash	172/338 (50.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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