Trial Outcomes & Findings for A Study of Changes in FDG- and FLT-PET Imaging in Patients With Non-Small Cell Lung Cancer Following Treatment With Erlotinib (NCT NCT00453362)
NCT ID: NCT00453362
Last Updated: 2017-03-31
Results Overview
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FDG-PET response and patients without FDG-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. Mean of the percent changes in maximal standard uptake values (mSUVmax) from FDG-PET scans was used to define FDG-PET response. Based on European Organization for Research on the Treatment of Cancer (EORTC) definitions, an objective FDG-PET response was defined an mSUVmax \<-25%.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
88 participants
Primary outcome timeframe
Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
Results posted on
2017-03-31
Participant Flow
A single-arm, open-label, multicenter, international pilot study. The study was expected to enroll approximately 100 evaluable patients at approximately eight sites in Australia and the United States. The study was initiated on 6 DEC 2006 and completed on 23 APR 2010.
Participant milestones
| Measure |
Erlotinib
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
After 14 days and after 56 days of treatment with Erlotinib participants underwent FDG-PET (2-deoxy-2-\[18F\]fluoro-D-glucose-Positron Emission Tomogrpahy)and FLT-PET (3'-deoxy-3'-\[18F\]fluorothymidine-Positron Emission Tomogrpahy) scans.
FDG-PET intravenous injection dosage was based on participant's weight not to exceed 15 mCi and FLT-PET intravenous dose was 7 mCi.
|
|---|---|
|
Overall Study
STARTED
|
88
|
|
Overall Study
Treated With Erlotinib
|
74
|
|
Overall Study
FDG-PET Evaluable
|
51
|
|
Overall Study
FLT-PET Evaluable
|
50
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
87
|
Reasons for withdrawal
| Measure |
Erlotinib
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
After 14 days and after 56 days of treatment with Erlotinib participants underwent FDG-PET (2-deoxy-2-\[18F\]fluoro-D-glucose-Positron Emission Tomogrpahy)and FLT-PET (3'-deoxy-3'-\[18F\]fluorothymidine-Positron Emission Tomogrpahy) scans.
FDG-PET intravenous injection dosage was based on participant's weight not to exceed 15 mCi and FLT-PET intravenous dose was 7 mCi.
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Death
|
7
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Progression of disease
|
56
|
|
Overall Study
Screening Failure
|
14
|
Baseline Characteristics
A Study of Changes in FDG- and FLT-PET Imaging in Patients With Non-Small Cell Lung Cancer Following Treatment With Erlotinib
Baseline characteristics by cohort
| Measure |
Erlotinib
n=74 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
|
|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 yearsPopulation: FDG-Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis. Censoring occurred at the date of the last tumor assessment.
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FDG-PET response and patients without FDG-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. Mean of the percent changes in maximal standard uptake values (mSUVmax) from FDG-PET scans was used to define FDG-PET response. Based on European Organization for Research on the Treatment of Cancer (EORTC) definitions, an objective FDG-PET response was defined an mSUVmax \<-25%.
Outcome measures
| Measure |
Erlotinib_FDG Responders
n=6 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group.
|
Erlotinib_ FDG Non-Responders
n=45 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group.
|
|---|---|---|
|
Progression Free Survival (PFS) of Groups by FDG Response at Day 56
|
28.1 weeks
Interval 16.14 to 40.14
|
12.1 weeks
Interval 7.86 to 51.14
|
PRIMARY outcome
Timeframe: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 yearsPopulation: FDG-Evaluable patients were treated with erlotinib, underwent all FDG-PET scans through Day 56 and had SD by CT at Day 56. Censoring at last tumor assessment. CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start.
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FDG-PET response (Complete /Partial Responses) and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response; defined as a mSUVmax from FDG-PET scans of \<-25% and FDG-PET disease progression; defined as a mSUVmax \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Outcome measures
| Measure |
Erlotinib_FDG Responders
n=3 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group.
|
Erlotinib_ FDG Non-Responders
n=10 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group.
|
|---|---|---|
|
PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56
|
32.1 weeks
Interval 18.0 to 32.14
|
14.9 weeks
Interval 8.14 to 32.14
|
PRIMARY outcome
Timeframe: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 yearsPopulation: FLT-Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis. Censoring occurred at the date of the last tumor assessment.
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25%.
Outcome measures
| Measure |
Erlotinib_FDG Responders
n=4 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group.
|
Erlotinib_ FDG Non-Responders
n=46 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group.
|
|---|---|---|
|
Progression Free Survival of Groups by FLT Response at Day 56
|
39.9 weeks
Interval 18.0 to 40.14
|
13.1 weeks
Interval 7.86 to 51.14
|
PRIMARY outcome
Timeframe: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 yearsPopulation: FLT-Evaluable patients were treated with erlotinib, underwent all FLT-PET scans through Day 56 and had SD by CT at Day 56. Censoring at last tumor assessment. CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start.
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of computed tomography (CT) response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Outcome measures
| Measure |
Erlotinib_FDG Responders
n=2 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group.
|
Erlotinib_ FDG Non-Responders
n=4 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group.
|
|---|---|---|
|
Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56
|
NA weeks
Interval 18.0 to 24.0
Not applicable. The median PFS of Day 56 FLT-PET responders was not estimable using Kaplan-Meier methodology.
Hazard ratio and confidence interval are not estimable due to the limited number of events.
|
12.9 weeks
Interval 8.29 to 17.29
|
PRIMARY outcome
Timeframe: From first erlotinib treatment to death, assessed up to 2 yearsPopulation: FDG-Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis. Censoring occurred at the last date patients known to be alive.
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. Overall survival (OS) was compared between patients with FDG-PET response and patients without FDG-PET response, independent of Response Evaluation Criteria in Solid Tumors (RECIST 1.0) computed tomography (CT) response at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans \<-25%.
Outcome measures
| Measure |
Erlotinib_FDG Responders
n=6 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group.
|
Erlotinib_ FDG Non-Responders
n=45 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group.
|
|---|---|---|
|
Overall Survival of Groups by FDG Response at Day 56
|
NA months
Interval 4.99 to 23.98
Not applicable. The median OS of Day 56 FDG-PET responders was not estimable using Kaplan-Meier methodology.
|
7.8 months
Interval 1.94 to 24.51
|
PRIMARY outcome
Timeframe: From first erlotinib treatment to death, assessed up to 2 yearsPopulation: Patients who were treated with erlotinib, underwent all FDG-PET scans thru Day 56 and had SD by CT at Day 56. Censoring at last date patients known to be alive. CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start.
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FDG-PET response and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease (SD) on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans \<-25% and FDG-PET disease progression was defined as a mSUVmax from FDG-PET scans \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Outcome measures
| Measure |
Erlotinib_FDG Responders
n=3 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group.
|
Erlotinib_ FDG Non-Responders
n=10 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group.
|
|---|---|---|
|
Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56
|
12.2 months
Interval 4.99 to 17.84
|
8.8 months
Interval 2.37 to 20.07
|
PRIMARY outcome
Timeframe: From first erlotinib treatment to death, assessed up to 2 yearsPopulation: FLT-Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis. Censoring occurred at the last date patients known to be alive.
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25%.
Outcome measures
| Measure |
Erlotinib_FDG Responders
n=4 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group.
|
Erlotinib_ FDG Non-Responders
n=46 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group.
|
|---|---|---|
|
Overall Survival of Groups by FLT Response at Day 56
|
NA months
Interval 4.99 to 23.98
Not applicable. The median OS of Day 56 FLT-PET responders was not estimable using Kaplan-Meier methodology.
|
8.4 months
Interval 1.94 to 24.51
|
PRIMARY outcome
Timeframe: From first erlotinib treatment to death, assessed up to 2 yearsPopulation: Patients who were treated with erlotinib,underwent all FLT-PET scans thru Day 56 and had SD by CT at Day 56. Censoring at last date patients known to be alive. CT SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FLT-PET response and patients with FLT-PET progression, within the subset of patients who demonstrated SD on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans of \<-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Outcome measures
| Measure |
Erlotinib_FDG Responders
n=2 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group.
|
Erlotinib_ FDG Non-Responders
n=4 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group.
|
|---|---|---|
|
Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56
|
NA months
Interval 4.99 to 17.84
Not applicable. The median OS of Day 56 FLT-PET responders was not estimable using Kaplan-Meier methodology.
|
8 months
Interval 2.37 to 14.29
|
SECONDARY outcome
Timeframe: Day 14 and Day 56Population: FDG-Evaluable patients. Participants who were treated with erlotinib, underwent all FDG-PET scans through Day 56 and had stable disease by CT at Day 56 were included in the analysis.
In patients with computed tomography (CT)-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses after the initial 14 days and 56 days of erlotinib treatment. FDG-PET response was defined as a mSUVmax from FDG-PET scans \<-25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
Outcome measures
| Measure |
Erlotinib_FDG Responders
n=26 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group.
|
Erlotinib_ FDG Non-Responders
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group.
|
|---|---|---|
|
Percentage of Patients With FDG-PET Responses
Day 14 response
|
7.7 Percentage of Participants
Interval 1.4 to 23.4
|
—
|
|
Percentage of Patients With FDG-PET Responses
Day 56 response
|
11.5 Percentage of Participants
Interval 3.2 to 29.9
|
—
|
SECONDARY outcome
Timeframe: Day 14 and Day 56Population: FLT-Evaluable Patients. Participants who were treated with erlotinib, underwent all FLT-PET scans through Day 56 and had stable disease by CT at Day 56 were included in the analysis.
In patients with CT-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses after the initial 14 days and 56 days of erlotinib treatment. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
Outcome measures
| Measure |
Erlotinib_FDG Responders
n=26 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group.
|
Erlotinib_ FDG Non-Responders
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group.
|
|---|---|---|
|
Percentage of Patients With FLT-PET Responses
Day 14 response
|
7.7 Percentage of Participants
Interval 1.4 to 23.4
|
—
|
|
Percentage of Patients With FLT-PET Responses
Day 56 response
|
7.7 Percentage of Participants
Interval 1.4 to 23.4
|
—
|
SECONDARY outcome
Timeframe: Day 56Population: FDG-Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis.
In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses on Day 56 defined as a mSUVmax from FDG-PET scans \<-25%. CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD. CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions.
Outcome measures
| Measure |
Erlotinib_FDG Responders
n=51 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group.
|
Erlotinib_ FDG Non-Responders
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group.
|
|---|---|---|
|
FDG Response in Subgroups by CT Response at Day 56
CT Partial response (n=4)
|
75 Percentage of participants
Interval 24.9 to 98.7
|
—
|
|
FDG Response in Subgroups by CT Response at Day 56
CT Progressive Disease (n=21)
|
0 Percentage of participants
Interval 0.0 to 14.6
|
—
|
SECONDARY outcome
Timeframe: Day 56Population: FLT-Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis.
In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses on Day 56 defined as a mSUVmax from FLT-PET scans \<-25%. CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD. CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions.
Outcome measures
| Measure |
Erlotinib_FDG Responders
n=50 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group.
|
Erlotinib_ FDG Non-Responders
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group.
|
|---|---|---|
|
FLT Response in Subgroups by CT Response at Day 56
CT Partial response (n=4)
|
50 Percentage of participants
Interval 9.8 to 90.2
|
—
|
|
FLT Response in Subgroups by CT Response at Day 56
CT Progressive Disease (n=20)
|
0 Percentage of participants
Interval 0.0 to 15.4
|
—
|
SECONDARY outcome
Timeframe: From screening to Day 112 assessment visit or study discontinuation or termination, whichever is first. On visits after Day 112, only SAE were recorded.Population: Patients with non-small cell lung cancer (NSCLC) who underwent FLT-PET scans.
The number of participants who experienced an adverse event judged by the investigator to be related to FLT-PET.
Outcome measures
| Measure |
Erlotinib_FDG Responders
n=85 Participants
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group.
|
Erlotinib_ FDG Non-Responders
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group.
|
|---|---|---|
|
Number of Participants With Adverse Events Due to FLT-PET Imaging
|
0 Participants
|
—
|
Adverse Events
Erlotinib
Serious events: 37 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib
n=85 participants at risk
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
After 14 days and after 56 days of treatment with Erlotinib, participants underwent FDG-PET and FLT-PET scans. FDG-PET intravenous injection-dosage based on participant's weight not to exceed 15 mCi and FLT-PET intravenous dose of 7 mCi.
|
|---|---|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Congenital, familial and genetic disorders
TRACHEO-OESOPHAGEAL FISTULA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
2.4%
2/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Gastrointestinal disorders
NAUSEA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
General disorders
DISEASE PROGRESSION
|
5.9%
5/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
General disorders
FATIGUE
|
2.4%
2/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
General disorders
PYREXIA
|
2.4%
2/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Infections and infestations
PNEUMONIA
|
4.7%
4/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Infections and infestations
BRONCHITIS
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Infections and infestations
GANGRENE
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Infections and infestations
INFECTION
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Infections and infestations
LOBAR PNEUMONIA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Injury, poisoning and procedural complications
FALL
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
2.4%
2/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.4%
2/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER
|
4.7%
4/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Nervous system disorders
HEADACHE
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Nervous system disorders
PARAESTHESIA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Nervous system disorders
PRESYNCOPE
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
3.5%
3/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Psychiatric disorders
DEPRESSION
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Psychiatric disorders
DISORIENTATION
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Renal and urinary disorders
URINARY RETENTION
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
2.4%
2/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
Other adverse events
| Measure |
Erlotinib
n=85 participants at risk
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
After 14 days and after 56 days of treatment with Erlotinib, participants underwent FDG-PET and FLT-PET scans. FDG-PET intravenous injection-dosage based on participant's weight not to exceed 15 mCi and FLT-PET intravenous dose of 7 mCi.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.4%
2/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Congenital, familial and genetic disorders
TRACHEO-OESOPHAGEAL FISTULA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Gastrointestinal disorders
DIARRHOEA
|
2.4%
2/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Gastrointestinal disorders
NAUSEA
|
2.4%
2/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Gastrointestinal disorders
DYSPHAGIA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Gastrointestinal disorders
MELAENA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
General disorders
FATIGUE
|
7.1%
6/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
General disorders
DISEASE PROGRESSION
|
5.9%
5/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
General disorders
PAIN
|
2.4%
2/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
General disorders
PYREXIA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Infections and infestations
PNEUMONIA
|
4.7%
4/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Infections and infestations
BRONCHITIS
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Infections and infestations
CELLULITIS
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Infections and infestations
DERMATITIS INFECTED
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Infections and infestations
GANGRENE
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Infections and infestations
INFECTION
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Infections and infestations
LOBAR PNEUMONIA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Infections and infestations
PARONYCHIA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
2.4%
2/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
2.4%
2/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.5%
3/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER
|
4.7%
4/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Nervous system disorders
HEADACHE
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Nervous system disorders
NEURALGIA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Nervous system disorders
PARAESTHESIA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Nervous system disorders
SCIATICA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
2.4%
2/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Psychiatric disorders
ANXIETY
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Psychiatric disorders
DEPRESSION
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Psychiatric disorders
DISORIENTATION
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Renal and urinary disorders
URINARY RETENTION
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
3.5%
3/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Skin and subcutaneous tissue disorders
RASH
|
5.9%
5/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
|
Vascular disorders
HYPOTENSION
|
1.2%
1/85 • Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients \[n = 85\].
|
Additional Information
Medical Communications
Hoffman-LaRoche
Phone: 800-821-8590
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