Trial Outcomes & Findings for An Observational Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer (NCT NCT01535729)
NCT ID: NCT01535729
Last Updated: 2015-10-29
Results Overview
Overall survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall percentage of participants who were alive 1 year after study treatment and those based on the factor of age (65-69, 70-74, 75-79, ≥ 80 years) were reported.
COMPLETED
465 participants
Year 1
2015-10-29
Participant Flow
Participant milestones
| Measure |
Non-small Cell Lung Cancer (NSCLC) Elderly Participants
Elderly Participants (greater than or equal to \[≥\] 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Overall Study
STARTED
|
465
|
|
Overall Study
Treated
|
385
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
416
|
Reasons for withdrawal
| Measure |
Non-small Cell Lung Cancer (NSCLC) Elderly Participants
Elderly Participants (greater than or equal to \[≥\] 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Disease progression
|
230
|
|
Overall Study
Discontinued treatment
|
25
|
|
Overall Study
Lost to Follow-up
|
8
|
|
Overall Study
Death
|
52
|
|
Overall Study
Other
|
19
|
|
Overall Study
Did not sign informed consent
|
1
|
|
Overall Study
No previous chemotherapy
|
33
|
|
Overall Study
NSCLC grade IV histology not confirmed
|
20
|
|
Overall Study
Protocol Violation
|
11
|
|
Overall Study
Screening failure
|
1
|
|
Overall Study
Not treated
|
9
|
|
Overall Study
No participant record available
|
5
|
Baseline Characteristics
An Observational Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Age, Continuous
|
72.66 years
STANDARD_DEVIATION 5.23 • n=93 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
258 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Year 1Population: SAF
Overall survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall percentage of participants who were alive 1 year after study treatment and those based on the factor of age (65-69, 70-74, 75-79, ≥ 80 years) were reported.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Percentage of Participants Who Were Alive 1 Year After Start of Treatment
Overall
|
30.6 percentage of participants
Interval 25.2 to 36.0
|
|
Percentage of Participants Who Were Alive 1 Year After Start of Treatment
65-69 years
|
26.6 percentage of participants
Interval 16.8 to 36.3
|
|
Percentage of Participants Who Were Alive 1 Year After Start of Treatment
70-74 years
|
29.8 percentage of participants
Interval 20.6 to 39.0
|
|
Percentage of Participants Who Were Alive 1 Year After Start of Treatment
75-79 years
|
37.2 percentage of participants
Interval 26.3 to 48.2
|
|
Percentage of Participants Who Were Alive 1 Year After Start of Treatment
≥ 80 years
|
25.6 percentage of participants
Interval 9.0 to 42.3
|
SECONDARY outcome
Timeframe: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)Population: SAF
Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. Median survival based on the factor of age (65-69, 70-74, 75-79, ≥80 years) were reported.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Median Overall Survival: Age
65-69 years
|
7.039 months
Interval 5.033 to 8.717
|
|
Median Overall Survival: Age
70-74 years
|
6.612 months
Interval 5.164 to 8.125
|
|
Median Overall Survival: Age
75-79 years
|
7.928 months
Interval 6.118 to 11.349
|
|
Median Overall Survival: Age
≥ 80 years
|
6.020 months
Interval 4.507 to 10.954
|
SECONDARY outcome
Timeframe: Months 3, 6, 9, 12Population: SAF
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Percentage of Participants With Fatigue
Month 3
|
89.1 percentage of participants
|
|
Percentage of Participants With Fatigue
Month 6
|
38.7 percentage of participants
|
|
Percentage of Participants With Fatigue
Month 9
|
19.5 percentage of participants
|
|
Percentage of Participants With Fatigue
Month 12
|
13.8 percentage of participants
|
SECONDARY outcome
Timeframe: Months 3, 6, 9, 12Population: SAF
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Percentage of Participants With Rash
Month 3
|
90.6 percentage of participants
|
|
Percentage of Participants With Rash
Month 6
|
37.9 percentage of participants
|
|
Percentage of Participants With Rash
Month 9
|
19.5 percentage of participants
|
|
Percentage of Participants With Rash
Month 12
|
13.8 percentage of participants
|
SECONDARY outcome
Timeframe: Months 3, 6, 9, 12Population: SAF
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Percentage of Participants With Diarrhea
Month 3
|
89.6 percentage of participants
|
|
Percentage of Participants With Diarrhea
Month 6
|
39.0 percentage of participants
|
|
Percentage of Participants With Diarrhea
Month 12
|
13.8 percentage of participants
|
|
Percentage of Participants With Diarrhea
Month 9
|
19.5 percentage of participants
|
SECONDARY outcome
Timeframe: Months 3, 6, 9, 12Population: SAF
Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4= life-threatening consequences; urgent intervention indicated. Grade 5= death related to adverse event. Only participants that were included in any of the specified categories were reported.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Percentage of Participants With Rash Based on Severity During the Course of Time
Month 3: Grade 1
|
19.2 percentage of participants
|
|
Percentage of Participants With Rash Based on Severity During the Course of Time
Month 3: Grade 2
|
23.1 percentage of participants
|
|
Percentage of Participants With Rash Based on Severity During the Course of Time
Month 3: Grade 3
|
4.4 percentage of participants
|
|
Percentage of Participants With Rash Based on Severity During the Course of Time
Month 6: Grade 1
|
8.1 percentage of participants
|
|
Percentage of Participants With Rash Based on Severity During the Course of Time
Month 6: Grade 2
|
5.7 percentage of participants
|
|
Percentage of Participants With Rash Based on Severity During the Course of Time
Month 6: Grade 3
|
1.0 percentage of participants
|
|
Percentage of Participants With Rash Based on Severity During the Course of Time
Month 12: Grade 2
|
1.6 percentage of participants
|
|
Percentage of Participants With Rash Based on Severity During the Course of Time
Month 9: Grade 1
|
3.6 percentage of participants
|
|
Percentage of Participants With Rash Based on Severity During the Course of Time
Month 9: Grade 2
|
2.3 percentage of participants
|
|
Percentage of Participants With Rash Based on Severity During the Course of Time
Month 12: Grade 1
|
1.8 percentage of participants
|
SECONDARY outcome
Timeframe: Months 3, 6, 9, 12Population: SAF
Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4= life-threatening consequences; urgent intervention indicated. Grade 5= death related to adverse event. Only participants that were included in any of the specified categories were reported.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Percentage of Participants With Diarrhea Based on Severity During the Course of Time
Month 3: Grade 2
|
7.3 percentage of participants
|
|
Percentage of Participants With Diarrhea Based on Severity During the Course of Time
Month 3: Grade 1
|
11.9 percentage of participants
|
|
Percentage of Participants With Diarrhea Based on Severity During the Course of Time
Month 6: Grade 3
|
0.3 percentage of participants
|
|
Percentage of Participants With Diarrhea Based on Severity During the Course of Time
Month 9: Grade 1
|
1.0 percentage of participants
|
|
Percentage of Participants With Diarrhea Based on Severity During the Course of Time
Month 3: Grade 3
|
0.3 percentage of participants
|
|
Percentage of Participants With Diarrhea Based on Severity During the Course of Time
Month 3: Grade 4
|
0.3 percentage of participants
|
|
Percentage of Participants With Diarrhea Based on Severity During the Course of Time
Month 6: Grade 1
|
2.3 percentage of participants
|
|
Percentage of Participants With Diarrhea Based on Severity During the Course of Time
Month 6: Grade 2
|
0.8 percentage of participants
|
|
Percentage of Participants With Diarrhea Based on Severity During the Course of Time
Month 9: Grade 2
|
0.3 percentage of participants
|
|
Percentage of Participants With Diarrhea Based on Severity During the Course of Time
Month 9: Grade 3
|
0.3 percentage of participants
|
|
Percentage of Participants With Diarrhea Based on Severity During the Course of Time
Month 12: Grade 1
|
0.3 percentage of participants
|
SECONDARY outcome
Timeframe: Months 3, 6, 9, 12Population: SAF
Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4= life-threatening consequences; urgent intervention indicated. Grade 5= death related to adverse event. Only participants that were included in any of the specified categories were reported.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Percentage of Participants With Fatigue Based on Severity During the Course of Time
Month 3: Grade 2
|
8.1 percentage of participants
|
|
Percentage of Participants With Fatigue Based on Severity During the Course of Time
Month 3: Grade 3
|
0.3 percentage of participants
|
|
Percentage of Participants With Fatigue Based on Severity During the Course of Time
Month 6: Grade 1
|
1.8 percentage of participants
|
|
Percentage of Participants With Fatigue Based on Severity During the Course of Time
Month 6: Grade 3
|
0.3 percentage of participants
|
|
Percentage of Participants With Fatigue Based on Severity During the Course of Time
Month 9: Grade 2
|
0.5 percentage of participants
|
|
Percentage of Participants With Fatigue Based on Severity During the Course of Time
Month 12: Grade 1
|
0.5 percentage of participants
|
|
Percentage of Participants With Fatigue Based on Severity During the Course of Time
Month 12: Grade 2
|
0.3 percentage of participants
|
|
Percentage of Participants With Fatigue Based on Severity During the Course of Time
Month 6: Grade 2
|
1.8 percentage of participants
|
|
Percentage of Participants With Fatigue Based on Severity During the Course of Time
Month 9: Grade 1
|
1.0 percentage of participants
|
|
Percentage of Participants With Fatigue Based on Severity During the Course of Time
Month 3: Grade 1
|
6.8 percentage of participants
|
SECONDARY outcome
Timeframe: Months 3, 6, 9, 12Population: SAF
Dose modification included increase or decreased in the dose of the drug and interrupted dose. Reasons for dose modification included progression, participants' wish, intolerance and others. Only participants that were included in any of the specified categories were reported.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Percentage of Participants With Dose Modifications by Reason
Month 3: Increased (other)
|
1.0 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 6: Increased (other)
|
0.8 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 9: Increased (other)
|
0.3 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 12: Increased (participants' wish)
|
0.3 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 12: Increased (other)
|
0.3 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 3: Decreased (participants' wish)
|
0.3 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 3: Decreased (intolerance)
|
7.0 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 3: Decreased (other)
|
0.8 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 6: Decreased (participants' wish)
|
0.8 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 6: Decreased (intolerance)
|
1.6 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 6: Decreased (other)
|
0.3 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 9: Decreased (intolerance)
|
0.8 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 9: Decreased (other)
|
0.3 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 3: Interruption (progression)
|
0.3 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 3: Interruption (intolerance)
|
1.8 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 3: Interruption (other)
|
2.9 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 9: Interruption (progression)
|
0.5 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 9: Interruption (other)
|
0.3 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 12: Interruption (other)
|
0.5 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 12: Decreased (intolerance)
|
0.5 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 6: Interruption (progression)
|
1.0 percentage of participants
|
|
Percentage of Participants With Dose Modifications by Reason
Month 6: Interruption (other)
|
1.6 percentage of participants
|
SECONDARY outcome
Timeframe: Months 3, 6, 9, 12Population: SAF
Reasons for dose withdrawals included progression, participants' wish, intolerance, others and not known. Only participants that were included in any of the specified categories were reported.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Percentage of Participants With Dose Withdrawals by Reason
Month 3: Progression
|
34.3 percentage of participants
|
|
Percentage of Participants With Dose Withdrawals by Reason
Month 3: Participants' wish
|
2.9 percentage of participants
|
|
Percentage of Participants With Dose Withdrawals by Reason
Month 3: Intolerance
|
3.4 percentage of participants
|
|
Percentage of Participants With Dose Withdrawals by Reason
Month 3: Other
|
8.3 percentage of participants
|
|
Percentage of Participants With Dose Withdrawals by Reason
Month 3: Not known
|
1.0 percentage of participants
|
|
Percentage of Participants With Dose Withdrawals by Reason
Month 6: Progression
|
12.7 percentage of participants
|
|
Percentage of Participants With Dose Withdrawals by Reason
Month 6: Participants' wish
|
0.5 percentage of participants
|
|
Percentage of Participants With Dose Withdrawals by Reason
Month 6: Intolerance
|
0.3 percentage of participants
|
|
Percentage of Participants With Dose Withdrawals by Reason
Month 6: Other
|
2.9 percentage of participants
|
|
Percentage of Participants With Dose Withdrawals by Reason
Month 6: Not known
|
0.3 percentage of participants
|
|
Percentage of Participants With Dose Withdrawals by Reason
Month 9: Progression
|
4.7 percentage of participants
|
|
Percentage of Participants With Dose Withdrawals by Reason
Month 9: Participants' wish
|
0.3 percentage of participants
|
|
Percentage of Participants With Dose Withdrawals by Reason
Month 9: Intolerance
|
0.3 percentage of participants
|
|
Percentage of Participants With Dose Withdrawals by Reason
Month 9: Other
|
1.0 percentage of participants
|
|
Percentage of Participants With Dose Withdrawals by Reason
Month 12: Progression
|
2.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9, 12Population: SAF
Severity of cough was categorized as mild, moderate, severe and unknown. Only participants that were included in any of the specified categories in the course of time were reported. Participants with no cough were not included.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Percentage of Participants With Cough by Severity
Baseline: Mild
|
13.8 percentage of participants
|
|
Percentage of Participants With Cough by Severity
Baseline: Moderate
|
24.9 percentage of participants
|
|
Percentage of Participants With Cough by Severity
Baseline: Severe
|
2.9 percentage of participants
|
|
Percentage of Participants With Cough by Severity
Baseline: Unknown
|
1.6 percentage of participants
|
|
Percentage of Participants With Cough by Severity
Month 3: Mild
|
15.1 percentage of participants
|
|
Percentage of Participants With Cough by Severity
Month 3: Moderate
|
14.5 percentage of participants
|
|
Percentage of Participants With Cough by Severity
Month 3: Severe
|
0.3 percentage of participants
|
|
Percentage of Participants With Cough by Severity
Month 3: Unknown
|
0.5 percentage of participants
|
|
Percentage of Participants With Cough by Severity
Month 6: Mild
|
4.4 percentage of participants
|
|
Percentage of Participants With Cough by Severity
Month 6: Moderate
|
3.6 percentage of participants
|
|
Percentage of Participants With Cough by Severity
Month 6: Severe
|
0.3 percentage of participants
|
|
Percentage of Participants With Cough by Severity
Month 6: Unknown
|
0.5 percentage of participants
|
|
Percentage of Participants With Cough by Severity
Month 9: Mild
|
4.7 percentage of participants
|
|
Percentage of Participants With Cough by Severity
Month 9: Moderate
|
0.5 percentage of participants
|
|
Percentage of Participants With Cough by Severity
Month 9: Unknown
|
0.3 percentage of participants
|
|
Percentage of Participants With Cough by Severity
Month 12: Mild
|
1.8 percentage of participants
|
|
Percentage of Participants With Cough by Severity
Month 12: Moderate
|
1.3 percentage of participants
|
|
Percentage of Participants With Cough by Severity
Month 12: Severe
|
0.3 percentage of participants
|
|
Percentage of Participants With Cough by Severity
Month 12: Unknown
|
0.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9, 12Population: SAF
Severity of dyspnea was categorized as mild, moderate, severe, life-threatening and unknown. Only participants that were included in any of the specified categories in the course of time were reported. Participants with no dyspnea were not included.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Percentage of Participants With Dyspnea by Severity
Baseline: Mild
|
16.1 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Baseline: Moderate
|
20.3 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Baseline: Severe
|
8.1 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Baseline: Unknown
|
1.3 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Month 3: Mild
|
10.1 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Month 3: Life-threatening
|
0.3 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Month 3: Unknown
|
0.8 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Month 6: Mild
|
4.7 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Month 6: Moderate
|
3.4 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Month 6: Severe
|
2.1 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Month 6: Unknown
|
0.3 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Month 9: Mild
|
3.4 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Month 9: Moderate
|
1.0 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Month 9: Severe
|
0.5 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Month 9: Unknown
|
0.3 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Month 12: Mild
|
1.6 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Month 12: Moderate
|
0.8 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Month 12: Severe
|
0.5 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Month 12: Unknown
|
0.3 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Month 3: Moderate
|
17.4 percentage of participants
|
|
Percentage of Participants With Dyspnea by Severity
Month 3: Severe
|
4.4 percentage of participants
|
SECONDARY outcome
Timeframe: Months 3, 6, 9, 12Population: SAF
Response rate was observed during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST). It consisted of CR, PR, SD and progressive disease (PD). Participants with CR, PR and SD were reported. CR: disappearance of all target lesions (TLs) and non-TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). PR: at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the baseline (BL) sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)
Month 3: CR
|
0.8 percentage of participants
|
|
Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)
Month 3: PR
|
4.9 percentage of participants
|
|
Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)
Month 3: SD
|
25.2 percentage of participants
|
|
Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)
Month 6: CR
|
0.5 percentage of participants
|
|
Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)
Month 6: PR
|
3.1 percentage of participants
|
|
Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)
Month 6: SD
|
14.3 percentage of participants
|
|
Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)
Month 9: CR
|
0.3 percentage of participants
|
|
Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)
Month 9: PR
|
1.6 percentage of participants
|
|
Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)
Month 9: PD
|
10.6 percentage of participants
|
|
Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)
Month 12: CR
|
0.5 percentage of participants
|
|
Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)
Month 12: PR
|
1.6 percentage of participants
|
|
Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)
Month 12: SD
|
8.1 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: SAF with number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=373 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Time to Start of Erlotinib Therapy After End of First Line Therapy
|
2.30 months
Interval 0.03 to 100.39
|
SECONDARY outcome
Timeframe: Months 3, 6, 9, 12Population: SAF
Remission was defined as participants with CR or PR. CR: disappearance of all TLs and non-TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Percentage of Participants With Remission of CR and PR
Month 3
|
5.7 percentage of participants
|
|
Percentage of Participants With Remission of CR and PR
Month 6
|
3.6 percentage of participants
|
|
Percentage of Participants With Remission of CR and PR
Month 9
|
1.8 percentage of participants
|
|
Percentage of Participants With Remission of CR and PR
Month 12
|
2.1 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)Population: SAF
Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression no death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Median Progression Free Survival: Overall
|
3.5 months
Interval 3.2 to 3.9
|
SECONDARY outcome
Timeframe: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)Population: SAF
Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Median progression-free survival based on the factor of age (65-69, 70-74, 75-79, ≥80 years) were reported.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Median Progression Free Survival: Age
65-69 years
|
3.257 months
Interval 2.632 to 3.914
|
|
Median Progression Free Survival: Age
70-74 years
|
3.388 months
Interval 2.763 to 4.079
|
|
Median Progression Free Survival: Age
75-79 years
|
5.033 months
Interval 3.717 to 6.382
|
|
Median Progression Free Survival: Age
≥ 80 years
|
2.928 months
Interval 2.039 to 3.75
|
SECONDARY outcome
Timeframe: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)Population: SAF
Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Median progression-free survival based on the factor of gender (male and female) were reported.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Median Progression Free Survival: Gender
Male
|
3.355 months
Interval 2.993 to 3.75
|
|
Median Progression Free Survival: Gender
Female
|
4.046 months
Interval 3.257 to 5.888
|
SECONDARY outcome
Timeframe: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)Population: SAF
Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Median progression-free survival based on the factor of smoking status (smoker, non-smoker and ex-smoker) were reported.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Median Progression Free Survival: Smoking Status
Non-smoker
|
5.526 months
Interval 3.849 to 10.855
|
|
Median Progression Free Survival: Smoking Status
Ex-smoker
|
2.993 months
Interval 2.566 to 3.487
|
|
Median Progression Free Survival: Smoking Status
Smoker
|
3.454 months
Interval 2.928 to 4.572
|
SECONDARY outcome
Timeframe: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)Population: Data for best response to prior chemotherapy could not be collected, as it was not recorded in the Case Report Form (CRF), hence, the analysis could not be performed.
Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)Population: SAF
Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Median Overall Survival: Overall
|
7.1 months
Interval 6.0 to 7.9
|
SECONDARY outcome
Timeframe: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)Population: SAF
Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. Median survival based on the factor of gender (male and female) were reported.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Median Overall Survival: Gender
Male
|
6.283 months
Interval 5.526 to 7.467
|
|
Median Overall Survival: Gender
Female
|
8.125 months
Interval 6.349 to 12.237
|
SECONDARY outcome
Timeframe: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)Population: SAF
Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. Median survival based on the factor of smoking status (smoker, non-smoker and ex-smoker) were reported.
Outcome measures
| Measure |
NSCLC Elderly Participants
n=385 Participants
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Median Overall Survival: Smoking Status
Smoker
|
6.612 months
Interval 5.329 to 8.388
|
|
Median Overall Survival: Smoking Status
Non-smoker
|
11.184 months
Interval 7.928 to
Upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
|
Median Overall Survival: Smoking Status
Ex-smoker
|
5.855 months
Interval 5.033 to 7.27
|
SECONDARY outcome
Timeframe: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)Population: Data for best response to prior chemotherapy could not be collected, as it was not recorded in the CRF, hence, the analysis could not be performed.
Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods.
Outcome measures
Outcome data not reported
Adverse Events
NSCLC Elderly Participants
Serious adverse events
| Measure |
NSCLC Elderly Participants
n=385 participants at risk
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
4/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Eye disorders
Visual impairment
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Gastrointestinal disorders
Constipation
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Gastrointestinal disorders
Nausea
|
0.78%
3/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Gastrointestinal disorders
Vomiting
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
General disorders
Asthenia
|
0.52%
2/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
General disorders
Chest pain
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
General disorders
Disease progression
|
0.52%
2/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
General disorders
Fatigue
|
0.52%
2/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
General disorders
General physical health deterioration
|
1.6%
6/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
General disorders
Pain
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
General disorders
Pyrexia
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Infections and infestations
Furuncle
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Infections and infestations
Gangrene
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Infections and infestations
Infection
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Infections and infestations
Paronychia
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Infections and infestations
Pneumonia
|
2.3%
9/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Infections and infestations
Rash pustular
|
1.0%
4/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Infections and infestations
Sepsis
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Investigations
C-reactive protein increased
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Investigations
Liver function test abnormal
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Investigations
Oxygen saturation decreased
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
4/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
4.2%
16/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Nervous system disorders
Motor dysfunction
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Nervous system disorders
Speech disorder
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Renal and urinary disorders
Renal failure
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Renal and urinary disorders
Urinary retention
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
8/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.78%
3/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Reproductive system and breast disorders
Pleural effusion
|
0.78%
3/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
10/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Vascular disorders
Deep vein thrombosis
|
0.26%
1/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
Other adverse events
| Measure |
NSCLC Elderly Participants
n=385 participants at risk
Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
13.5%
52/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
General disorders
Fatigue
|
10.6%
41/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.8%
30/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.4%
36/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.8%
84/385 • Up to Month 40 (Maximum follow-up)
SAF.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER