Trial Outcomes & Findings for An Observational Study of Erlotinib Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer (NCT NCT01782690)
NCT ID: NCT01782690
Last Updated: 2018-07-23
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
338 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2018-07-23
Participant Flow
Participant milestones
| Measure |
Erlotinib Plus Gemcitabine
Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
|
|---|---|
|
Overall Study
STARTED
|
338
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
299
|
Reasons for withdrawal
| Measure |
Erlotinib Plus Gemcitabine
Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
|
|---|---|
|
Overall Study
Not reported
|
7
|
|
Overall Study
Toxicity of gemcitabine
|
1
|
|
Overall Study
Toxicity of erlotinib
|
1
|
|
Overall Study
Lost to Follow-up
|
31
|
|
Overall Study
Withdrawal of informed consent
|
2
|
|
Overall Study
Absent rash
|
9
|
|
Overall Study
Physician Decision
|
13
|
|
Overall Study
Patient's wish
|
21
|
|
Overall Study
Tumor progression
|
74
|
|
Overall Study
Death
|
133
|
|
Overall Study
Study completion unknown
|
7
|
Baseline Characteristics
An Observational Study of Erlotinib Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Erlotinib Plus Gemcitabine
n=338 Participants
Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
|
|---|---|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
203 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Full Analysis Set (FAS) included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.
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.
Outcome measures
| Measure |
Erlotinib Plus Gemcitabine
n=270 Participants
Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
|
|---|---|
|
Overall Survival Stratified by Rash
Rash = Yes
|
9.9288 months
95% Confidence Interval 0.5066 • Interval 7.9562 to
N/A=Not Available: Upper Limit not estimable
|
|
Overall Survival Stratified by Rash
Rash = No
|
8.6795 months
95% Confidence Interval 0.3151 • Interval 7.2658 to
N/A=Not Available: Upper Limit not estimable
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Safety population included all participants who received at least one treatment with study medication.
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.
Outcome measures
| Measure |
Erlotinib Plus Gemcitabine
n=338 Participants
Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
|
|---|---|
|
Number of Participants With Rash by Severity
Total number with rash
|
174 participants
|
|
Number of Participants With Rash by Severity
Paronychia Grade 1
|
10 participants
|
|
Number of Participants With Rash by Severity
Paronychia Grade 2
|
7 participants
|
|
Number of Participants With Rash by Severity
Paronychia Grade 3
|
2 participants
|
|
Number of Participants With Rash by Severity
Dry skin Grade 1
|
62 participants
|
|
Number of Participants With Rash by Severity
Dry skin Grade 2
|
26 participants
|
|
Number of Participants With Rash by Severity
Papulopustulous eczema Grade 1
|
89 participants
|
|
Number of Participants With Rash by Severity
Papulopustulous eczema Grade 2
|
69 participants
|
|
Number of Participants With Rash by Severity
Papulopustulous eczema Grade 3
|
6 participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Safety population included all participants who received at least one treatment with study medication.
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.
Outcome measures
| Measure |
Erlotinib Plus Gemcitabine
n=338 Participants
Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
|
310 participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Safety population included all participants who received at least one treatment with study medication
Reported is the total number of dose modifications/withdrawals for erlotinib.
Outcome measures
| Measure |
Erlotinib Plus Gemcitabine
n=338 Participants
Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
|
|---|---|
|
Number of Dose Modifications and Dose Withdrawals of Erlotinib
|
152 dose modifications/withdrawals
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Safety population included all participants who received at least one treatment with study medication
Reported is the number of dose modifications/withdrawals for gemcitabine.
Outcome measures
| Measure |
Erlotinib Plus Gemcitabine
n=338 Participants
Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
|
|---|---|
|
Number of Dose Modifications and Dose Withdrawals of Gemcitabine
|
738 dose modifications/withdrawals
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Safety population included all participants who received at least one treatment with study medication.
Reported is the number of days from first erlotinib treatment to first rash onset.
Outcome measures
| Measure |
Erlotinib Plus Gemcitabine
n=338 Participants
Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
|
|---|---|
|
Time of Onset of Rash After Start Erlotinib Treatment
|
18.4 days
Standard Deviation 21.6
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.
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.
Outcome measures
| Measure |
Erlotinib Plus Gemcitabine
n=270 Participants
Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
|
|---|---|
|
Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
ECOG-PS grade 0-1
|
9.8301 months
95% Confidence Interval 0.3726 • Interval 8.2192 to
N/A=Not Available: Upper Limit not estimable
|
|
Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
ECOG-PS grade 2
|
6.3452 months
95% Confidence Interval 0.7396 • Interval 4.011 to
N/A=Not Available: Upper Limit not estimable
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.
Best overall response was defined as complete response (CR) plus partial response (PR). Tumor evaluations were performed in accordance with daily routine practice.
Outcome measures
| Measure |
Erlotinib Plus Gemcitabine
n=270 Participants
Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
|
|---|---|
|
Percentage of Participants With Best Overall Response
|
24.74 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.
Disease progression was defined in accordance with daily routine practice.
Outcome measures
| Measure |
Erlotinib Plus Gemcitabine
n=270 Participants
Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
|
|---|---|
|
Time to Disease Progression
|
4.3726 months
95% Confidence Interval 0.2945 • Interval 3.8795 to 5.063
|
SECONDARY outcome
Timeframe: At Weeks 4, 8, 9 and 16Population: Safety population included all participants who received at least one treatment with study medication.
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.
Outcome measures
| Measure |
Erlotinib Plus Gemcitabine
n=338 Participants
Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
|
|---|---|
|
Score in Patient Questionnaire: Possible Side Effects
Week 4
|
1.9 scores on a scale
Standard Deviation 0.9
|
|
Score in Patient Questionnaire: Possible Side Effects
Week 8
|
1.9 scores on a scale
Standard Deviation 0.9
|
|
Score in Patient Questionnaire: Possible Side Effects
Week 9
|
1.0 scores on a scale
Standard Deviation NA
Data based on one participant and therefore standard deviation not available.
|
|
Score in Patient Questionnaire: Possible Side Effects
Week 16
|
1.9 scores on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: At Weeks 4, 8, 9 and 16Population: Safety population included all participants who received at least one treatment with study medication.
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.
Outcome measures
| Measure |
Erlotinib Plus Gemcitabine
n=338 Participants
Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
|
|---|---|
|
Score in Participant Questionnaire: What to Do in Case of Side Effect
Week 4
|
1.9 scores on a scale
Standard Deviation 0.8
|
|
Score in Participant Questionnaire: What to Do in Case of Side Effect
Week 8
|
2.0 scores on a scale
Standard Deviation 1.0
|
|
Score in Participant Questionnaire: What to Do in Case of Side Effect
Week 9
|
1.0 scores on a scale
Standard Deviation NA
Data based on one participant and therefore standard deviation not available.
|
|
Score in Participant Questionnaire: What to Do in Case of Side Effect
Week 16
|
1.9 scores on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: At Weeks 4, 8, 9 and 16Population: Safety population included all participants who received at least one treatment with study medication.
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.
Outcome measures
| Measure |
Erlotinib Plus Gemcitabine
n=338 Participants
Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
|
|---|---|
|
Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation
Week 4
|
2.6 scores on a scale
Standard Deviation 1.1
|
|
Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation
Week 8
|
2.6 scores on a scale
Standard Deviation 1.1
|
|
Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation
Week 9
|
6.0 scores on a scale
Standard Deviation NA
Data based on one participant and therefore standard deviation not available.
|
|
Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation
Week 16
|
2.7 scores on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: At Weeks 4, 8, 9 and 16Population: Safety population included all participants who received at least one treatment with study medication.
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.
Outcome measures
| Measure |
Erlotinib Plus Gemcitabine
n=338 Participants
Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
|
|---|---|
|
Score in Participant Questionnaire: Quality of Life
Week 8
|
2.9 scores on a scale
Standard Deviation 1.2
|
|
Score in Participant Questionnaire: Quality of Life
Week 4
|
2.9 scores on a scale
Standard Deviation 1.1
|
|
Score in Participant Questionnaire: Quality of Life
Week 9
|
1.0 scores on a scale
Standard Deviation NA
Data based on one participant and therefore standard deviation not available.
|
|
Score in Participant Questionnaire: Quality of Life
Week 16
|
2.9 scores on a scale
Standard Deviation 1.1
|
Adverse Events
Erlotinib Plus Gemcitabine
Serious events: 171 serious events
Other events: 261 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib Plus Gemcitabine
n=338 participants at risk
Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
6/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.89%
3/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.89%
3/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Cardiac disorders
Cardiac failure
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Eye disorders
Ocular icterus
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
6/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
5/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Ascites
|
2.4%
8/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.89%
3/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
4/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Gastritis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
4/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Haematemesis
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Ileus
|
1.2%
4/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Melaena
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Nausea
|
2.7%
9/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Subileus
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.1%
7/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
7/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Adverse event
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Asthenia
|
1.2%
4/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Chills
|
0.89%
3/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Death
|
2.7%
9/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Device dislocation
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Device occlusion
|
1.8%
6/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Disease progression
|
1.8%
6/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Fatigue
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
General physical health deterioration
|
12.1%
41/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Oedema peripheral
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Pain
|
2.7%
9/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Performance status decreased
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Peripheral swelling
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Pyrexia
|
2.7%
9/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Stent malfunction
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Ulcer
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Ulcer haemorrhage
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Hepatobiliary disorders
Cholangitis
|
4.1%
14/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Hepatobiliary disorders
Cholestatis
|
2.4%
8/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Hepatobiliary disorders
Jaundice
|
2.4%
8/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Hepatobiliary disorders
Jaundice extrahepatic obstructive
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Bronchitis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Bronchopneumonia
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Cholangitis infective
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Cystitis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Device related infection
|
0.89%
3/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Diverticulitis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Endocarditis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Endophthalmitis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Erysipelas
|
0.89%
3/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Escherichia infection
|
0.89%
3/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Infection
|
3.0%
10/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Lobar pneumonia
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Pneumonia
|
2.7%
9/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Pulmonary sepsis
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Sepsis
|
0.89%
3/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Streptococcal sepsis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Urosepsis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Injury, poisoning and procedural complications
Biliary anastomosis complication
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Investigations
Blood alkaline phosphatase abnormal
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Investigations
Blood bilirubin abnormal
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Investigations
Blood bilirubin increased
|
0.89%
3/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Investigations
Blood creatinine increased
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Investigations
Blood glucose increased
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Investigations
Body temperature increased
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Investigations
Haemoglobin abnormal
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Investigations
Haemoglobin decreased
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Investigations
Neutrophil count decreased
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Investigations
Platelet count decreased
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Investigations
Weight decreased
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Investigations
White blood cell count abnormal
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Investigations
White blood cell count decreased
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Investigations
White blood cell count increased
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.89%
3/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Metabolism and nutrition disorders
Diet refusal
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
17.2%
58/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour compression
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour invasion
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Nervous system disorders
Altered state of consciousness
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Nervous system disorders
Aphasia
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Nervous system disorders
Cerebral infarction
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Nervous system disorders
Disturbance in attention
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Nervous system disorders
Hemiplegia
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Nervous system disorders
Hypoaesthesia
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Nervous system disorders
IIIrd nerve disorder
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Nervous system disorders
Sensory disturbance
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Nervous system disorders
VIth nerve paralysis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Psychiatric disorders
Disorientation
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Psychiatric disorders
Personality change
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Psychiatric disorders
Restlessness
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Renal and urinary disorders
Dysuria
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Renal and urinary disorders
Haematuria
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Renal and urinary disorders
Pollakiuria
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Renal and urinary disorders
Renal failure
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Renal and urinary disorders
Renal failure acute
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Renal and urinary disorders
Urinary retention
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
8/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
5/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
5/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
4/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Surgical and medical procedures
Bile duct stent insertion
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Vascular disorders
Embolism
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Vascular disorders
Hypertensive crisis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Vascular disorders
Infarction
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Vascular disorders
Thrombophlebitis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Vascular disorders
Thrombosis
|
0.59%
2/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Vascular disorders
Trousseau's syndrome
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Vascular disorders
Varicose vein
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Vascular disorders
Vena cava thrombosis
|
0.30%
1/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Vascular disorders
Venous thrombosis limb
|
0.89%
3/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
Other adverse events
| Measure |
Erlotinib Plus Gemcitabine
n=338 participants at risk
Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
5.6%
19/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.2%
48/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Nausea
|
19.5%
66/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
20/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Fatigue
|
14.5%
49/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Oedema peripheral
|
7.7%
26/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Pain
|
18.0%
61/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Infection
|
6.8%
23/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Investigations
Haemoglobin abnormal
|
10.4%
35/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Investigations
Platelet count abnormal
|
11.2%
38/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Investigations
White blood cell count abnormal
|
11.8%
40/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
24/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.9%
172/338 • Up to 12 months
Safety population included all participants who received at least one treatment with study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER