Trial Outcomes & Findings for Rapid Plasma Genotyping For Early Initiation Of Erlotinib In EGFR Mutant Lung Cancer (NCT NCT02770014)
NCT ID: NCT02770014
Last Updated: 2019-11-22
Results Overview
Number of participants who were alive with evidence of complete or partial response, evaluated using RECIST 1.1 criteria. Patients that underwent rapid plasma genotyping and had an EGFR mutation and who were treated with erlotinib were included in this calculation.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
From date of erlotinib initiation until the date of first documented disease progression or date of death from any cause, whichever came first. ORR was assessed up to 21 months after erlotinib initiation.
Results posted on
2019-11-22
Participant Flow
Participant milestones
| Measure |
Participants With Plasma Genotyping
Participants who enrolled to the study and had plasma genotyping
|
|---|---|
|
Plasma Genotyping
STARTED
|
43
|
|
Plasma Genotyping
COMPLETED
|
43
|
|
Plasma Genotyping
NOT COMPLETED
|
0
|
|
EGFR Exon 19 Pos, Treated With Erlotinib
STARTED
|
11
|
|
EGFR Exon 19 Pos, Treated With Erlotinib
COMPLETED
|
6
|
|
EGFR Exon 19 Pos, Treated With Erlotinib
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rapid Plasma Genotyping For Early Initiation Of Erlotinib In EGFR Mutant Lung Cancer
Baseline characteristics by cohort
| Measure |
Participants With Plasma Genotyping
n=43 Participants
Participants who enrolled to the study and had plasma genotyping
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
|
Smoking Status
Former Smoker
|
14 Participants
n=5 Participants
|
|
Smoking Status
Never Smoker
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of erlotinib initiation until the date of first documented disease progression or date of death from any cause, whichever came first. ORR was assessed up to 21 months after erlotinib initiation.Population: A total of 6 participants were treated with erlotinib on study.
Number of participants who were alive with evidence of complete or partial response, evaluated using RECIST 1.1 criteria. Patients that underwent rapid plasma genotyping and had an EGFR mutation and who were treated with erlotinib were included in this calculation.
Outcome measures
| Measure |
EGFR Exon 19 Positive Treatment With Erlotinib
n=6 Participants
Erlotinib will be initially dosed at a pre-determine dosage daily, and it will be given on a 6-week cycle with treatment administered on an outpatient basis
|
|---|---|
|
Overall Response Rate
|
4 Participants
|
SECONDARY outcome
Timeframe: Maximum 38 daysPopulation: A total of 42 participants had plasma genotyping results available (1 of the 43 enrolled participants did not have plasma genotyping).
The turnaround time from study registration to treatment initiation was recorded for the plasma genotyping strategy versus standard tumor genotyping. For rapid plasma genotyping, turnaround time is the time between ordering plasma genotyping and obtaining results; this time period was compared to the turnaround time of obtaining the tumor genotyping results.
Outcome measures
| Measure |
EGFR Exon 19 Positive Treatment With Erlotinib
n=42 Participants
Erlotinib will be initially dosed at a pre-determine dosage daily, and it will be given on a 6-week cycle with treatment administered on an outpatient basis
|
|---|---|
|
Turnaround Time
Turnaround Time: Plasma Genotyping
|
4 days
Interval 1.0 to 11.0
|
|
Turnaround Time
Turnaround Time: Tumor Genotyping
|
20 days
Interval 8.0 to 38.0
|
SECONDARY outcome
Timeframe: PPV and False Negative Rate can be assessed when plasma and tissue results are available for each patient; average plasma result turnaround time was 4 days, versus average of 20 days for tissue result turnaround time.Population: 35 of the 42 participants with plasma genotyping results also had tumor genotyping results available, so PPV and false negative rate could be assessed in these 35 participants.
Concordance between results of plasma genotyping and tumor genotyping, among patients with tissue available for standard genotyping
Outcome measures
| Measure |
EGFR Exon 19 Positive Treatment With Erlotinib
n=35 Participants
Erlotinib will be initially dosed at a pre-determine dosage daily, and it will be given on a 6-week cycle with treatment administered on an outpatient basis
|
|---|---|
|
Positive Predictive Value (PPV) And False Negative Rate Of Plasma Genotyping
Positive Predictive Value
|
100 percentage
|
|
Positive Predictive Value (PPV) And False Negative Rate Of Plasma Genotyping
False Negative Rate
|
30 percentage
|
Adverse Events
EGFR Exon 19 Positive Treatment With Erlotinib
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EGFR Exon 19 Positive Treatment With Erlotinib
n=6 participants at risk
Erlotinib will be initially dosed at a pre-determine dosage daily, and it will be given on a 6-week cycle with treatment administered on an outpatient basis
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Number of events 3 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 4 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
3/6 • Number of events 3 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
2/6 • Number of events 2 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Gastrointestinal disorders
Gastritis
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 2 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
General disorders
Chills
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 2 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • Number of events 5 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Infections and infestations
Papulopustular rash
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Infections and infestations
Paronychia
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Infections and infestations
Skin infection
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Investigations
Serum amylase increased
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Number of events 4 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
2/6 • Number of events 4 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • Number of events 2 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
33.3%
2/6 • Number of events 2 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
50.0%
3/6 • Number of events 3 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness trunk
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Nervous system disorders
Dizziness
|
50.0%
3/6 • Number of events 3 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 2 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 4 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Number of events 2 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Number of events 2 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
16.7%
1/6 • Number of events 4 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
|
Skin and subcutaneous tissue disorders
Skin/subcutaneous tissue disorders; Other, specify
|
16.7%
1/6 • Number of events 4 • Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place