Trial Outcomes & Findings for The Study Observes How Long Patients With Non-small Cell Lung Cancer (NSCLC) Benefit From Treatment With Epidermal Growth Factor Tyrosine Kinase Inhibitor (EGFR-TKI) When Given Either for Uncommon Mutations or for Common Mutations in the Sequence Afatinib Followed by Osimertinib (NCT NCT04179890)
NCT ID: NCT04179890
Last Updated: 2023-05-25
Results Overview
Uncommon Mutation Cohort: Time on treatment with EGFR-TKI assessed as the time from start of EGFR-TKI treatment until the end of treatment or death by any cause is reported. Common mutation cohort: Time on treatment with EGFR-TKI assessed as the time from start of afatinib (Gi(l)otrif®) as first-line treatment until the end of the second line treatment (the last dose of osimertinib) or death date by any cause. Time on treatment was analysed using Kaplan-Meier method, and the median was tabulated along with two-sided 95% confidence interval using the Greenwood's variance estimate.
Recruitment status
COMPLETED
Target enrollment
462 participants
Primary outcome timeframe
Up to 13 years for Uncommon EGFR mutation cohort and up to 6 years for the Sequencing Cohort.
Results posted on
2023-05-25
Participant Flow
A Real world, non-interventional study based on existing data from medical records or electronic health records. The study aimed to collect more information on the benefit of individual Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) treatment for the uncommon mutations and the overall benefit for the sequential EGFR TKI treatment with afatinib and osimertinib for the common EGFR mutations on patients with Non-Small Cell Lung Cancer (NSCLC).
Every patient who fulfilled inclusion and exclusion criteria and agreed to participate in the study was selected until the required sample size was achieved. Deceased and untraceable patients were enrolled whenever possible and discussed with the local authorities.
Participant milestones
| Measure |
Uncommon EGFR Mutation Cohort
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
|---|---|---|
|
Overall Study
STARTED
|
255
|
207
|
|
Overall Study
Eligible Patients
|
246
|
191
|
|
Overall Study
COMPLETED
|
246
|
191
|
|
Overall Study
NOT COMPLETED
|
9
|
16
|
Reasons for withdrawal
| Measure |
Uncommon EGFR Mutation Cohort
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
|---|---|---|
|
Overall Study
Patients not harbouring uncommon or compound EGFR mutations
|
3
|
0
|
|
Overall Study
Patients who did not start EGFR-TKI treatment at least 12 months prior to data entry
|
1
|
0
|
|
Overall Study
Patients treated for EGFR mutated NSCLC within a clinical trial
|
3
|
0
|
|
Overall Study
Patients with active brain metastases at start of EGFR-TKI therapy
|
2
|
0
|
|
Overall Study
Patients not treated with afatinib in first-line or with osimertinib in second line
|
0
|
8
|
|
Overall Study
Patients not starting osimertinib treatment at least 10 months prior to data entry
|
0
|
4
|
|
Overall Study
Patients with active brain metastases at start of EGFR-TKI therapy (independent of treatment line)
|
0
|
2
|
|
Overall Study
Patients without common EGFR mutations (Del19, L858R)
|
0
|
1
|
|
Overall Study
Patients treated for EGFR mutated NSCLC within a clinical trial or participated in GioTag study
|
0
|
1
|
Baseline Characteristics
The Study Observes How Long Patients With Non-small Cell Lung Cancer (NSCLC) Benefit From Treatment With Epidermal Growth Factor Tyrosine Kinase Inhibitor (EGFR-TKI) When Given Either for Uncommon Mutations or for Common Mutations in the Sequence Afatinib Followed by Osimertinib
Baseline characteristics by cohort
| Measure |
Uncommon EGFR Mutation Cohort
n=246 Participants
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
n=191 Participants
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
Total
n=437 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.6 Years
STANDARD_DEVIATION 11.0 • n=99 Participants
|
61.4 Years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
64.89 Years
STANDARD_DEVIATION 11.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=99 Participants
|
106 Participants
n=107 Participants
|
244 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
193 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
206 Participants
n=99 Participants
|
118 Participants
n=107 Participants
|
324 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 13 years for Uncommon EGFR mutation cohort and up to 6 years for the Sequencing Cohort.Population: Eligible Patients set (Uncommon mutation cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. Eligible Patients set (Sequencing cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable.
Uncommon Mutation Cohort: Time on treatment with EGFR-TKI assessed as the time from start of EGFR-TKI treatment until the end of treatment or death by any cause is reported. Common mutation cohort: Time on treatment with EGFR-TKI assessed as the time from start of afatinib (Gi(l)otrif®) as first-line treatment until the end of the second line treatment (the last dose of osimertinib) or death date by any cause. Time on treatment was analysed using Kaplan-Meier method, and the median was tabulated along with two-sided 95% confidence interval using the Greenwood's variance estimate.
Outcome measures
| Measure |
Uncommon EGFR Mutation Cohort
n=246 Participants
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
n=191 Participants
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
|---|---|---|
|
Time on Treatment With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)
|
9.89 Months
Interval 7.75 to 11.56
|
27.7 Months
Interval 23.95 to 30.23
|
SECONDARY outcome
Timeframe: Up to 13 years.Population: Eligible Patients set (Uncommon mutation cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable.
Overall response rate (ORR) using RECIST criteria as assessed by investigator. ORR to index line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) treatment is reported (ORR is defined as number of patients with complete or partial response evaluated by Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1)). (Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR).
Outcome measures
| Measure |
Uncommon EGFR Mutation Cohort
n=246 Participants
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
|---|---|---|
|
Uncommon Epidermal Growth Factor Receptor (EGFR) Mutation Cohort: Overall Response Rate to Index Line Treatment
|
96 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 6 years.Population: Eligible Patients set (Sequencing cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable.
Overall response rate (ORR) using RECIST criteria as assessed by investigator. Overall response rate to first line afatinib treatment for the Common Epidermal Growth Factor Receptor (EGFR) mutation cohort is reported. (ORR is defined as number of patients with complete or partial response evaluated by Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1)). (Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR).
Outcome measures
| Measure |
Uncommon EGFR Mutation Cohort
n=191 Participants
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
|---|---|---|
|
Sequencing Cohort: Overall Response Rate to First Line Afatinib
|
131 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 6 years.Population: Eligible Patients set (Sequencing cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable.
Overall response rate (ORR) using RECIST criteria as assessed by investigator. Overall response rate to second-line treatment (Osimertinib) is reported. (ORR is defined as number of patients with complete or partial response evaluated by Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1)). (Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR).
Outcome measures
| Measure |
Uncommon EGFR Mutation Cohort
n=191 Participants
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
|---|---|---|
|
Sequencing Cohort: Overall Response Rate to Second-line Treatment Osimertinib
|
75 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 13 years for Uncommon EGFR mutation cohort and up to 6 years for the Sequencing Cohort.Population: Eligible Patients set (Uncommon mutation cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. Eligible Patients set (Sequencing cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable.
Uncommon Mutation Cohort: Overall survival since index line treatment start of Tyrosine Kinase Inhibitor (TKI) medication administered per generation until death date by any cause or the end of index line is reported. Sequencing cohort: Overall survival for since first-line afatinib treatment start until death date by any cause or the end of index line. Kaplan-Meier estimates of quartiles of time to death were computed (with their 95% Confidence Intervals, using Greenwood's variance estimate.
Outcome measures
| Measure |
Uncommon EGFR Mutation Cohort
n=246 Participants
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
n=191 Participants
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
|---|---|---|
|
Overall Survival
|
24.44 Months
Interval 20.24 to 28.16
|
36.50 Months
Interval 32.85 to 41.76
|
SECONDARY outcome
Timeframe: At first-line treatment start (i.e. between 2007 and 2019 for the Uncommon Epidermal Growth Factor Receptor (EGFR) mutation cohort and between 2014 and 2018 for Sequencing Cohort).Population: Eligible Patients set (Uncommon mutation cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. Eligible Patients set (Sequencing cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable.
Number of participants for each type of biological samples used for mutation detection at first line treatment start is reported. The reported types of biological samples are: * Tissue, histological sample (solid biopsy); * Cytological sample; * Blood (liquid biopsy); * Other and * Unknown.
Outcome measures
| Measure |
Uncommon EGFR Mutation Cohort
n=246 Participants
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
n=191 Participants
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
|---|---|---|
|
Number of Participants for Each Type of Biological Samples Used for Mutation Detection at First Line Treatment Start
Tissue, Histological sample (solid biopsy)
|
212 Participants
|
160 Participants
|
|
Number of Participants for Each Type of Biological Samples Used for Mutation Detection at First Line Treatment Start
Cytological sample
|
32 Participants
|
19 Participants
|
|
Number of Participants for Each Type of Biological Samples Used for Mutation Detection at First Line Treatment Start
Blood (liquid biopsy)
|
3 Participants
|
6 Participants
|
|
Number of Participants for Each Type of Biological Samples Used for Mutation Detection at First Line Treatment Start
Other
|
2 Participants
|
2 Participants
|
|
Number of Participants for Each Type of Biological Samples Used for Mutation Detection at First Line Treatment Start
Unknown
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At first-line treatment start (i.e. between 2007 and 2019 for the Uncommon Epidermal Growth Factor Receptor (EGFR) mutation cohort and between 2014 and 2018 for the Sequencing Cohort).Population: Eligible Patients set (Uncommon mutation cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. Eligible Patients set (Sequencing cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable.
Number of participants for each type of methodologies used for mutational testing is reported. The reported types of methodology are: * Amplification Refractory Mutation System (ARMS); * Polymerase Chain reactions (PCR)-based techniques; * Sequencing; * Next-Generation Sequencing (NGS); * Other; * Unknown.
Outcome measures
| Measure |
Uncommon EGFR Mutation Cohort
n=246 Participants
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
n=191 Participants
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
|---|---|---|
|
Number of Participants for Each Category of Methodology Used for Mutational Testing at First Line Treatment Start
Amplification Refractory Mutation System (ARMS)
|
4 Participants
|
4 Participants
|
|
Number of Participants for Each Category of Methodology Used for Mutational Testing at First Line Treatment Start
PCR-based techniques
|
155 Participants
|
122 Participants
|
|
Number of Participants for Each Category of Methodology Used for Mutational Testing at First Line Treatment Start
Sequencing
|
39 Participants
|
15 Participants
|
|
Number of Participants for Each Category of Methodology Used for Mutational Testing at First Line Treatment Start
Next-Generation Sequencing (NGS)
|
20 Participants
|
8 Participants
|
|
Number of Participants for Each Category of Methodology Used for Mutational Testing at First Line Treatment Start
Unknown
|
42 Participants
|
41 Participants
|
|
Number of Participants for Each Category of Methodology Used for Mutational Testing at First Line Treatment Start
Other
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From start of first-line treatment to stop of second-line or death by any cause, up to 13 years.Population: Eligible Patients set (Uncommon mutation cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable and who were initiated on a second line treatment.
Time on treatment until failure of second-line (TTF2), defined as time elapsed from start of first-line treatment (regardless the type of treatment) to stop of second-line (regardless of the type of treatment) or death by any cause is reported. Kaplan-Meier estimates of quartiles of time to second-line treatment failure were computed (with their 95% Confidence Intervals, using Greenwood's variance estimate).
Outcome measures
| Measure |
Uncommon EGFR Mutation Cohort
n=140 Participants
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
|---|---|---|
|
Uncommon Mutation Cohort: Time on Treatment Until Failure of Second-line (TTF2)
|
14.46 Months
Interval 13.24 to 18.0
|
—
|
SECONDARY outcome
Timeframe: At second-line treatment start (i.e. between 2007 and 16-Jul-2020 for "Uncommon EGFR mutation cohort" and between 2014 and 23-Oct-2020 for the "Sequencing CohortPopulation: Eligible Patients set: All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable and who were initiated on a second line treatment. For the Uncommon EGFR mutation cohort only patients with \>1 Non-Small Cell Lung Cancer (NSCLC) with re-evaluated mutational status.
Number of participants for each type of biological samples used for mutation detection at second line treatment start is reported. The reported types of biological samples are: * Tissue, Histological sample (solid biopsy); * Cytological sample; * Blood (liquid biopsy); * Not applicable-Clinical evaluation; * Other; * Unknown. Not applicable - Clinical evaluation: The uncommon Epidermal Growth Factor Receptor (EGFR) mutational status had become available after Progression on conventional second-line therapy. Erlotinib was given as state of the art second-line therapy in 2014, and an EGFR mutation was clinically suspected due to the Long-Lasting response. However, due to the unavailability of tumor tissue, this could be proven only after liquid biopsy had subsequently become available at the center in 2016. For the Sequencing cohort second-line treatment start is initiated by the beginning of the therapy with Osimertinib.
Outcome measures
| Measure |
Uncommon EGFR Mutation Cohort
n=34 Participants
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
n=191 Participants
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
|---|---|---|
|
Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Start
Tissue, Histological sample (solid biopsy)
|
22 Participants
|
93 Participants
|
|
Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Start
Cytological sample
|
3 Participants
|
18 Participants
|
|
Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Start
Blood (liquid biopsy)
|
8 Participants
|
57 Participants
|
|
Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Start
Not applicable - Clinical evaluation
|
1 Participants
|
0 Participants
|
|
Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Start
Other
|
0 Participants
|
7 Participants
|
|
Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Start
Unknown
|
0 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: At second-line treatment start (i.e. between 2007 and 16-Jul-2020 for Uncommon Epidermal Growth Factor Receptor (EGFR) mutation cohort and between 2014 and 23-Oct-2020 for the Sequencing Cohort).Population: Eligible Patients set: All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. For the Uncommon EGFR mutation cohort eligible patients with \>1 Non-Small Cell Lung Cancer (NSCLC) line with re-evaluated mutational status are reported.
Number of participants for each type of biological samples used for mutation detection at second line treatment stop/end of observation is reported. The reported categories of biological samples are: * Tissue, Histological sample (solid biopsy); * Cytological sample; * Blood (liquid biopsy); * Other.
Outcome measures
| Measure |
Uncommon EGFR Mutation Cohort
n=10 Participants
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
n=191 Participants
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
|---|---|---|
|
Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Stop/End of Observation
Tissue, Histological sample (solid biopsy)
|
5 Participants
|
9 Participants
|
|
Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Stop/End of Observation
Blood (liquid biopsy)
|
4 Participants
|
9 Participants
|
|
Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Stop/End of Observation
Other
|
1 Participants
|
0 Participants
|
|
Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Stop/End of Observation
Cytological sample
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 13 years.Population: Eligible Patients set: All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. 16 patients in the Uncommon EGFR mutation cohort who switched from first-line chemotherapy to second-line EGFR-TKI therapy for which EGFR mutational status was not re-evaluated at start of second-line treatment were not included in this group.
Number of participants for each type of biological samples used for mutation detection at index therapy start (index therapy refers to therapy switch from first-line chemotherapy to second-line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) therapy (index line)) is reported. The reported categories of biological samples are: * Tissue, Histological sample (solid biopsy); * Cytological sample; * Blood (liquid biopsy); * Other and * Unknown.
Outcome measures
| Measure |
Uncommon EGFR Mutation Cohort
n=230 Participants
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
|---|---|---|
|
Uncommon Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Index Therapy Start
Tissue, Histological sample (solid biopsy)
|
199 Participants
|
—
|
|
Uncommon Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Index Therapy Start
Cytological sample
|
29 Participants
|
—
|
|
Uncommon Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Index Therapy Start
Blood (liquid biopsy)
|
2 Participants
|
—
|
|
Uncommon Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Index Therapy Start
Other
|
2 Participants
|
—
|
|
Uncommon Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Index Therapy Start
Unknown
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: At second-line treatment start (i.e. between 2007 and 16-Jul-2020 for Uncommon Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR) mutation cohort and between 2014 and 23-Oct-2020 for the Sequencing Cohort).Population: Eligible Patients set: All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable and who were initiated on a second line treatment. For the Uncommon EGFR mutation cohort only patients with \>1 Non-Small Cell Lung Cancer (NSCLC) with re-evaluated mutational status.
Number of participants for each type of methodology used for mutational testing at second-line treatment start is reported. The reported types of methodologies are: * Amplification Refractory Mutation System (ARMS); * Polymerase Chain Reaction (PCR)-based techniques; * Sequencing; * Next-Generation Sequencing (NGS); * Other; * Unknown/Not applicable- Clinical evaluation.
Outcome measures
| Measure |
Uncommon EGFR Mutation Cohort
n=34 Participants
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
n=191 Participants
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
|---|---|---|
|
Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Start
PCR-based techniques
|
23 Participants
|
121 Participants
|
|
Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Start
Sequencing
|
2 Participants
|
2 Participants
|
|
Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Start
Next-Generation Sequencing (NGS)
|
3 Participants
|
13 Participants
|
|
Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Start
Unknown/Not applicable- Clinical evaluation
|
6 Participants
|
51 Participants
|
|
Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Start
Amplification Refractory Mutation System (ARMS)
|
0 Participants
|
3 Participants
|
|
Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Start
Other
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At second-line treatment stop/end of observation (i.e. between 2007 and 16-Jul-2020 for Uncommon Epidermal Growth Factor Receptor (EGFR) mutation cohort and between 2014 and 23-Oct-2020 for the Sequencing Cohort).Population: Eligible Patients set: All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable.
Number of participants for each type of methodology used for mutational testing is reported. The reported types of methodologies are: * Polymerase Chain Reaction (PCR)-based techniques; * Next-Generation Sequencing (NGS); * Unknown.
Outcome measures
| Measure |
Uncommon EGFR Mutation Cohort
n=10 Participants
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
n=16 Participants
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
|---|---|---|
|
Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Stop/End of Observation
PCR-based techniques
|
7 Participants
|
11 Participants
|
|
Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Stop/End of Observation
Next-Generation Sequencing (NGS)
|
2 Participants
|
2 Participants
|
|
Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Stop/End of Observation
Unknown
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 13 years.Population: Eligible Patients set: All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. 16 patients in the "Uncommon EGFR mutation cohort" who switched from first-line chemotherapy to second-line EGFR-TKI therapy for which EGFR mutational status was not re-evaluated at start of second-line treatment were not included in this group.
Number of participants for each type of methodology used for mutation detection at index therapy start is reported. Index therapy refers to therapy switch from first-line chemotherapy to second-line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) therapy (index line). The reported categories of methodology are: * Amplification Refractory Mutation System (ARMS), * Polymerase chain reaction based techniques (PCR-based techniques), * Sequencing, * Next-Generation Sequencing (NGS), * Unknown.
Outcome measures
| Measure |
Uncommon EGFR Mutation Cohort
n=230 Participants
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
|---|---|---|
|
Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Index Therapy Start
Amplification Refractory Mutation System (ARMS)
|
4 Participants
|
—
|
|
Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Index Therapy Start
PCR-based techniques
|
146 Participants
|
—
|
|
Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Index Therapy Start
Sequencing
|
34 Participants
|
—
|
|
Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Index Therapy Start
Next-Generation Sequencing (NGS)
|
18 Participants
|
—
|
|
Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Index Therapy Start
Unknown
|
41 Participants
|
—
|
SECONDARY outcome
Timeframe: At start of first-line chemotherapy before index line (i.e. between 2007 and 2019).Population: Eligible Patients set: All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. Only patients switching from first-line chemotherapy to second-line EGFR-TKI therapy (index line) for which EGFR mutational status was not re-evaluated at start of second-line treatment are reported.
Number of participants for each type of methodology used for mutation detection at start of first-line chemotherapy before index line is reported. The reported types of methodologies are: * PCR-based techniques; * Sequencing; * Next-Generation Sequencing (NGS); * Unknown. Index therapy refers to therapy switch from first-line chemotherapy to second-line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) therapy (index line).
Outcome measures
| Measure |
Uncommon EGFR Mutation Cohort
n=16 Participants
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
|---|---|---|
|
Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Start of First-line Chemotherapy Before Index Line
PCR-based techniques
|
9 Participants
|
—
|
|
Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Start of First-line Chemotherapy Before Index Line
Sequencing
|
5 Participants
|
—
|
|
Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Start of First-line Chemotherapy Before Index Line
Next-Generation Sequencing (NGS)
|
2 Participants
|
—
|
|
Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Start of First-line Chemotherapy Before Index Line
Unknown
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: At start of first-line chemotherapy before index line (i.e. between 2007 and 2019).Population: Eligible Patients set: All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. Only patients switching from first-line chemotherapy to second-line EGFR-TKI therapy (index line) for which EGFR mutational status was not re-evaluated at start of second-line treatment are reported.
Number of participants for each type of biological samples used for mutation detection at start of first-line chemotherapy before index line is reported. Index therapy refers to therapy switch from first-line chemotherapy to second-line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) therapy (index line). The reported types of biological samples are: * Tissue, Histological sample (solid biopsy); * Cytological sample, Blood (liquid biopsy).
Outcome measures
| Measure |
Uncommon EGFR Mutation Cohort
n=16 Participants
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
Sequencing Cohort
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
|---|---|---|
|
Uncommon Mutation Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Start of First-line Chemotherapy Before Index Line
Tissue, Histological sample (solid biopsy)
|
13 Participants
|
—
|
|
Uncommon Mutation Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Start of First-line Chemotherapy Before Index Line
Cytological sample
|
3 Participants
|
—
|
|
Uncommon Mutation Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Start of First-line Chemotherapy Before Index Line
Blood (liquid biopsy)
|
1 Participants
|
—
|
Adverse Events
Sequencing Cohort
Serious events: 12 serious events
Other events: 41 other events
Deaths: 0 deaths
Uncommon EGFR Mutation Cohort
Serious events: 6 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sequencing Cohort
n=44 participants at risk
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
Uncommon EGFR Mutation Cohort
n=35 participants at risk
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
1/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
0.00%
0/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
General disorders
Disease progression
|
2.3%
1/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
0.00%
0/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
Infections and infestations
Neutropenic sepsis
|
2.3%
1/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
0.00%
0/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
2.9%
1/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
2.9%
1/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
22.7%
10/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
8.6%
3/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
2.9%
1/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
2.9%
1/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
Other adverse events
| Measure |
Sequencing Cohort
n=44 participants at risk
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
\- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
|
Uncommon EGFR Mutation Cohort
n=35 participants at risk
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
* Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
* Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
* Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
* Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
77.3%
34/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
68.6%
24/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
Gastrointestinal disorders
Stomatitis
|
29.5%
13/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
34.3%
12/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
Infections and infestations
Paronychia
|
38.6%
17/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
34.3%
12/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
13.6%
6/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
34.3%
12/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.1%
4/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
5.7%
2/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
Skin and subcutaneous tissue disorders
Rash
|
43.2%
19/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
20.0%
7/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
Gastrointestinal disorders
Nausea
|
6.8%
3/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
0.00%
0/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
General disorders
Inflammation
|
6.8%
3/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
0.00%
0/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
General disorders
Mucosal inflammation
|
6.8%
3/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
0.00%
0/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
General disorders
Oedema peripheral
|
0.00%
0/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
8.6%
3/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.3%
1/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
5.7%
2/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.8%
3/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
2.9%
1/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
Skin and subcutaneous tissue disorders
Nail fold inflammation
|
0.00%
0/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
5.7%
2/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/44 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
5.7%
2/35 • From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER