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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01782690
Recruitment Status : Completed
First Posted : February 4, 2013
Results First Posted : July 23, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Pancreatic Cancer
Interventions Drug: erlotinib
Drug: gemcitabine
Enrollment 338
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erlotinib Plus Gemcitabine
Hide 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
Reason Not Completed
Not reported             7
Toxicity of gemcitabine             1
Toxicity of erlotinib             1
Lost to Follow-up             31
Withdrawal of informed consent             2
Absent rash             9
Physician Decision             13
Patient's wish             21
Tumor progression             74
Death             133
Study completion unknown             7
Arm/Group Title Erlotinib Plus Gemcitabine
Hide 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 Number of Baseline Participants 338
Hide Baseline Analysis Population Description
The baseline analysis population included all subjects who received at least one treatment with study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 338 participants
66.9  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 338 participants
Female
135
  39.9%
Male
203
  60.1%
1.Primary Outcome
Title Overall Survival Stratified by Rash
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 270
Median (95% Confidence Interval)
Unit of Measure: months
Rash = Yes
9.9288 [1] 
(7.9562 to NA)
Rash = No
8.6795 [1] 
(7.2658 to NA)
[1]
N/A=Not Available: Upper Limit not estimable
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.2361
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Rash by Severity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one treatment with study medication.
Arm/Group Title Erlotinib Plus Gemcitabine
Hide 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 Number of Participants Analyzed 338
Measure Type: Number
Unit of Measure: participants
Total number with rash 174
Paronychia Grade 1 10
Paronychia Grade 2 7
Paronychia Grade 3 2
Dry skin Grade 1 62
Dry skin Grade 2 26
Papulopustulous eczema Grade 1 89
Papulopustulous eczema Grade 2 69
Papulopustulous eczema Grade 3 6
3.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one treatment with study medication.
Arm/Group Title Erlotinib Plus Gemcitabine
Hide 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 Number of Participants Analyzed 338
Measure Type: Number
Unit of Measure: participants
310
4.Secondary Outcome
Title Number of Dose Modifications and Dose Withdrawals of Erlotinib
Hide Description Reported is the total number of dose modifications/withdrawals for erlotinib.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one treatment with study medication
Arm/Group Title Erlotinib Plus Gemcitabine
Hide 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 Number of Participants Analyzed 338
Measure Type: Number
Unit of Measure: dose modifications/withdrawals
152
5.Secondary Outcome
Title Number of Dose Modifications and Dose Withdrawals of Gemcitabine
Hide Description Reported is the number of dose modifications/withdrawals for gemcitabine.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one treatment with study medication
Arm/Group Title Erlotinib Plus Gemcitabine
Hide 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 Number of Participants Analyzed 338
Measure Type: Number
Unit of Measure: dose modifications/withdrawals
738
6.Secondary Outcome
Title Time of Onset of Rash After Start Erlotinib Treatment
Hide Description Reported is the number of days from first erlotinib treatment to first rash onset.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one treatment with study medication.
Arm/Group Title Erlotinib Plus Gemcitabine
Hide 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 Number of Participants Analyzed 338
Mean (Standard Deviation)
Unit of Measure: days
18.4  (21.6)
7.Secondary Outcome
Title Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.
Arm/Group Title Erlotinib Plus Gemcitabine
Hide 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 Number of Participants Analyzed 270
Median (95% Confidence Interval)
Unit of Measure: months
ECOG-PS grade 0-1
9.8301 [1] 
(8.2192 to NA)
ECOG-PS grade 2
6.3452 [1] 
(4.0110 to NA)
[1]
N/A=Not Available: Upper Limit not estimable
8.Secondary Outcome
Title Percentage of Participants With Best Overall Response
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.
Arm/Group Title Erlotinib Plus Gemcitabine
Hide 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 Number of Participants Analyzed 270
Measure Type: Number
Unit of Measure: percentage of participants
24.74
9.Secondary Outcome
Title Time to Disease Progression
Hide Description Disease progression was defined in accordance with daily routine practice.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.
Arm/Group Title Erlotinib Plus Gemcitabine
Hide 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 Number of Participants Analyzed 270
Median (95% Confidence Interval)
Unit of Measure: months
4.3726
(3.8795 to 5.0630)
10.Secondary Outcome
Title Score in Patient Questionnaire: Possible Side Effects
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one treatment with study medication.
Arm/Group Title Erlotinib Plus Gemcitabine
Hide 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 Number of Participants Analyzed 338
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4 Number Analyzed 180 participants
1.9  (0.9)
Week 8 Number Analyzed 141 participants
1.9  (0.9)
Week 9 Number Analyzed 1 participants
1.0 [1]   (NA)
Week 16 Number Analyzed 94 participants
1.9  (0.9)
[1]
Data based on one participant and therefore standard deviation not available.
11.Secondary Outcome
Title Score in Participant Questionnaire: What to Do in Case of Side Effect
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one treatment with study medication.
Arm/Group Title Erlotinib Plus Gemcitabine
Hide 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 Number of Participants Analyzed 338
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4 Number Analyzed 179 participants
1.9  (0.8)
Week 8 Number Analyzed 140 participants
2.0  (1.0)
Week 9 Number Analyzed 1 participants
1.0 [1]   (NA)
Week 16 Number Analyzed 94 participants
1.9  (0.7)
[1]
Data based on one participant and therefore standard deviation not available.
12.Secondary Outcome
Title Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one treatment with study medication.
Arm/Group Title Erlotinib Plus Gemcitabine
Hide 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 Number of Participants Analyzed 338
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4 Number Analyzed 179 participants
2.6  (1.1)
Week 8 Number Analyzed 140 participants
2.6  (1.1)
Week 9 Number Analyzed 1 participants
6.0 [1]   (NA)
Week 16 Number Analyzed 94 participants
2.7  (1.1)
[1]
Data based on one participant and therefore standard deviation not available.
13.Secondary Outcome
Title Score in Participant Questionnaire: Quality of Life
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one treatment with study medication.
Arm/Group Title Erlotinib Plus Gemcitabine
Hide 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 Number of Participants Analyzed 338
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 4 Number Analyzed 180 participants
2.9  (1.1)
Week 8 Number Analyzed 140 participants
2.9  (1.2)
Week 9 Number Analyzed 1 participants
1.0 [1]   (NA)
Week 16 Number Analyzed 94 participants
2.9  (1.1)
[1]
Data based on one participant and therefore standard deviation not available.
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
Hide 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 (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Erlotinib Plus Gemcitabine
Affected / at Risk (%)
Total   171/338 (50.59%) 
Blood and lymphatic system disorders   
Anaemia  1  6/338 (1.78%) 
Anaemia of malignant disease  1  1/338 (0.30%) 
Febrile neutropenia  1  1/338 (0.30%) 
Leukopenia  1  3/338 (0.89%) 
Neutropenia  1  3/338 (0.89%) 
Thrombocytopenia  1  1/338 (0.30%) 
Cardiac disorders   
Atrial fibrillation  1  1/338 (0.30%) 
Cardiac arrest  1  1/338 (0.30%) 
Cardiac failure  1  2/338 (0.59%) 
Congenital, familial and genetic disorders   
Pyloric stenosis  1  1/338 (0.30%) 
Eye disorders   
Ocular icterus  1  1/338 (0.30%) 
Gastrointestinal disorders   
Abdominal distension  1  1/338 (0.30%) 
Abdominal pain  1  6/338 (1.78%) 
Abdominal pain upper  1  5/338 (1.48%) 
Ascites  1  8/338 (2.37%) 
Constipation  1  3/338 (0.89%) 
Diarrhoea  1  4/338 (1.18%) 
Duodenal ulcer  1  1/338 (0.30%) 
Functional gastrointestinal disorder  1  1/338 (0.30%) 
Gastric stenosis  1  1/338 (0.30%) 
Gastric varices haemorrhage  1  1/338 (0.30%) 
Gastritis  1  1/338 (0.30%) 
Gastritis haemorrhagic  1  2/338 (0.59%) 
Gastrointestinal haemorrhage  1  4/338 (1.18%) 
Gastrointestinal ulcer haemorrhage  1  1/338 (0.30%) 
Gastrooesophageal reflux disease  1  2/338 (0.59%) 
Haematemesis  1  2/338 (0.59%) 
Ileus  1  4/338 (1.18%) 
Impaired gastric emptying  1  1/338 (0.30%) 
Mechanical ileus  1  1/338 (0.30%) 
Melaena  1  1/338 (0.30%) 
Nausea  1  9/338 (2.66%) 
Pancreatitis  1  1/338 (0.30%) 
Subileus  1  1/338 (0.30%) 
Upper gastrointestinal haemorrhage  1  7/338 (2.07%) 
Vomiting  1  7/338 (2.07%) 
General disorders   
Adverse event  1  1/338 (0.30%) 
Asthenia  1  4/338 (1.18%) 
Chills  1  3/338 (0.89%) 
Death  1  9/338 (2.66%) 
Device dislocation  1  2/338 (0.59%) 
Device occlusion  1  6/338 (1.78%) 
Disease progression  1  6/338 (1.78%) 
Fatigue  1  2/338 (0.59%) 
General physical health deterioration  1  41/338 (12.13%) 
Oedema peripheral  1  1/338 (0.30%) 
Pain  1  9/338 (2.66%) 
Performance status decreased  1  1/338 (0.30%) 
Peripheral swelling  1  2/338 (0.59%) 
Pyrexia  1  9/338 (2.66%) 
Stent malfunction  1  1/338 (0.30%) 
Ulcer  1  1/338 (0.30%) 
Ulcer haemorrhage  1  1/338 (0.30%) 
Hepatobiliary disorders   
Bile duct obstruction  1  2/338 (0.59%) 
Bile duct stenosis  1  1/338 (0.30%) 
Cholangitis  1  14/338 (4.14%) 
Cholecystitis acute  1  2/338 (0.59%) 
Cholestatis  1  8/338 (2.37%) 
Hepatic failure  1  2/338 (0.59%) 
Hydrocholecystis  1  1/338 (0.30%) 
Jaundice  1  8/338 (2.37%) 
Jaundice extrahepatic obstructive  1  1/338 (0.30%) 
Infections and infestations   
Bronchitis  1  1/338 (0.30%) 
Bronchopneumonia  1  1/338 (0.30%) 
Cholangitis infective  1  1/338 (0.30%) 
Cystitis  1  1/338 (0.30%) 
Device related infection  1  3/338 (0.89%) 
Diverticulitis  1  1/338 (0.30%) 
Endocarditis  1  1/338 (0.30%) 
Endophthalmitis  1  1/338 (0.30%) 
Erysipelas  1  3/338 (0.89%) 
Escherichia infection  1  3/338 (0.89%) 
Infection  1  10/338 (2.96%) 
Infective exacerbation of chronic obstructive airways disease  1  1/338 (0.30%) 
Lobar pneumonia  1  1/338 (0.30%) 
Pneumonia  1  9/338 (2.66%) 
Pulmonary sepsis  1  2/338 (0.59%) 
Sepsis  1  3/338 (0.89%) 
Streptococcal sepsis  1  1/338 (0.30%) 
Urinary tract infection  1  1/338 (0.30%) 
Urosepsis  1  1/338 (0.30%) 
Injury, poisoning and procedural complications   
Biliary anastomosis complication  1  1/338 (0.30%) 
Femoral neck fracture  1  1/338 (0.30%) 
Procedural pain  1  1/338 (0.30%) 
Investigations   
Blood alkaline phosphatase abnormal  1  1/338 (0.30%) 
Blood bilirubin abnormal  1  2/338 (0.59%) 
Blood bilirubin increased  1  3/338 (0.89%) 
Blood creatinine increased  1  1/338 (0.30%) 
Blood glucose increased  1  1/338 (0.30%) 
Body temperature increased  1  1/338 (0.30%) 
Haemoglobin abnormal  1  2/338 (0.59%) 
Haemoglobin decreased  1  2/338 (0.59%) 
Neutrophil count decreased  1  1/338 (0.30%) 
Platelet count decreased  1  1/338 (0.30%) 
Weight decreased  1  1/338 (0.30%) 
White blood cell count abnormal  1  1/338 (0.30%) 
White blood cell count decreased  1  2/338 (0.59%) 
White blood cell count increased  1  1/338 (0.30%) 
Metabolism and nutrition disorders   
Cachexia  1  1/338 (0.30%) 
Decreased appetite  1  3/338 (0.89%) 
Dehydration  1  2/338 (0.59%) 
Diabetes mellitus  1  1/338 (0.30%) 
Diet refusal  1  1/338 (0.30%) 
Malnutrition  1  1/338 (0.30%) 
Musculoskeletal and connective tissue disorders   
Bursitis  1  1/338 (0.30%) 
Intervertebral disc protrusion  1  1/338 (0.30%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Malignant neoplasm progression  1  58/338 (17.16%) 
Metastases to liver  1  1/338 (0.30%) 
Metastases to lung  1  1/338 (0.30%) 
Metastases to peritoneum  1  2/338 (0.59%) 
Metastasis  1  1/338 (0.30%) 
Neoplasm  1  1/338 (0.30%) 
Pancreatic carcinoma  1  2/338 (0.59%) 
Paraneoplastic syndrome  1  1/338 (0.30%) 
Tumour compression  1  1/338 (0.30%) 
Tumour invasion  1  1/338 (0.30%) 
Nervous system disorders   
Altered state of consciousness  1  1/338 (0.30%) 
Aphasia  1  1/338 (0.30%) 
Cerebral infarction  1  1/338 (0.30%) 
Cerebral ischaemia  1  2/338 (0.59%) 
Cerebrovascular accident  1  1/338 (0.30%) 
Disturbance in attention  1  1/338 (0.30%) 
Embolic cerebral infarction  1  1/338 (0.30%) 
Hemiplegia  1  1/338 (0.30%) 
Hypoaesthesia  1  1/338 (0.30%) 
IIIrd nerve disorder  1  1/338 (0.30%) 
Post herpetic neuralgia  1  1/338 (0.30%) 
Sensory disturbance  1  1/338 (0.30%) 
VIth nerve paralysis  1  1/338 (0.30%) 
Psychiatric disorders   
Disorientation  1  1/338 (0.30%) 
Personality change  1  1/338 (0.30%) 
Restlessness  1  1/338 (0.30%) 
Renal and urinary disorders   
Dysuria  1  1/338 (0.30%) 
Haematuria  1  1/338 (0.30%) 
Pollakiuria  1  1/338 (0.30%) 
Renal failure  1  2/338 (0.59%) 
Renal failure acute  1  2/338 (0.59%) 
Urinary retention  1  1/338 (0.30%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome  1  1/338 (0.30%) 
Alveolitis  1  1/338 (0.30%) 
Atelectasis  1  1/338 (0.30%) 
Dyspnoea  1  8/338 (2.37%) 
Epistaxis  1  1/338 (0.30%) 
Pleural effusion  1  5/338 (1.48%) 
Pneumonia aspiration  1  1/338 (0.30%) 
Pneumothorax  1  1/338 (0.30%) 
Pulmonary embolism  1  5/338 (1.48%) 
Respiratory failure  1  1/338 (0.30%) 
Skin and subcutaneous tissue disorders   
Rash  1  4/338 (1.18%) 
Skin hyperpigmentation  1  1/338 (0.30%) 
Skin ulcer  1  1/338 (0.30%) 
Surgical and medical procedures   
Bile duct stent insertion  1  1/338 (0.30%) 
Vascular disorders   
Deep vein thrombosis  1  2/338 (0.59%) 
Embolism  1  1/338 (0.30%) 
Hypertensive crisis  1  1/338 (0.30%) 
Infarction  1  1/338 (0.30%) 
Thrombophlebitis  1  1/338 (0.30%) 
Thrombosis  1  2/338 (0.59%) 
Trousseau's syndrome  1  1/338 (0.30%) 
Varicose vein  1  1/338 (0.30%) 
Vena cava thrombosis  1  1/338 (0.30%) 
Venous thrombosis limb  1  3/338 (0.89%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Erlotinib Plus Gemcitabine
Affected / at Risk (%)
Total   261/338 (77.22%) 
Gastrointestinal disorders   
Constipation  1  19/338 (5.62%) 
Diarrhoea  1  48/338 (14.20%) 
Nausea  1  66/338 (19.53%) 
Vomiting  1  20/338 (5.92%) 
General disorders   
Fatigue  1  49/338 (14.50%) 
Oedema peripheral  1  26/338 (7.69%) 
Pain  1  61/338 (18.05%) 
Infections and infestations   
Infection  1  23/338 (6.80%) 
Investigations   
Haemoglobin abnormal  1  35/338 (10.36%) 
Platelet count abnormal  1  38/338 (11.24%) 
White blood cell count abnormal  1  40/338 (11.83%) 
Metabolism and nutrition disorders   
Decreased appetite  1  24/338 (7.10%) 
Skin and subcutaneous tissue disorders   
Rash  1  172/338 (50.89%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01782690     History of Changes
Other Study ID Numbers: ML23024
First Submitted: January 31, 2013
First Posted: February 4, 2013
Results First Submitted: May 11, 2017
Results First Posted: July 23, 2018
Last Update Posted: July 23, 2018