| Primary | Body Mass Index (BMI): All Asian Participants | BMI was derived from body weight and height, and it was calculated as weight divided by height^2. | FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Kilogram per square meter | | Baseline (date of last non-missing measurement prior to dacomitinib initiation; from data collected for approx. [approximately] 89 months); data was evaluated in this observational study for approx. 35.5 months | | | | ID | Title | Description |
|---|
| OG000 | Dacomitinib 30 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG001 | Dacomitinib 45 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG002 | Dacomitinib Other Dose | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00022.6± 3.57
- OG00123.1± 3.44
- OG00226.4
|
|
| |
| Primary | Number of Participants Classified According to Smoking Status: All Asian Participants | Number of participants classified according to smoking status are presented in this outcome measure. Participants were classified into the following categories: current smoker, former smoker, never smoker and unknown. | FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). | Posted | | Count of Participants | | Participants | | Baseline (date of last non-missing measurement prior to dacomitinib initiation; from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months | | | | ID | Title | Description |
|---|
| OG000 | Dacomitinib 30 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG001 | Dacomitinib 45 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG002 | Dacomitinib Other Dose | |
|
| Primary | Number of Participants Classified According to Comorbidities: All Asian Participants | Number of participants classified According to comorbidities are presented in this outcome measure. Participants were classified into the following categories: any comorbidities, none and unknown. | FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). | Posted | | Count of Participants | | Participants | | Baseline (date of last non-missing measurement prior to dacomitinib initiation; from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months | | | | ID | Title | Description |
|---|
| OG000 | Dacomitinib 30 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG001 | Dacomitinib 45 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG002 | Dacomitinib Other Dose | |
|
| Primary | Number of Participants Classified According to NSCLC Staging: All Asian Participants | The number of participants classified according to the disease stages as 3B, 3C, 4A and 4B were reported in this outcome measure. Cancer stages were classified based on tumor size (T), metastasis to regional lymph nodes (LN) [N] and distant metastasis (M). Stages were 3B, 3C, 4A and 4B. Stage 3B (T1N3M0, T2N3M0, T3N2M0, T4N2M0). Stage 3C (T3N3M0 and T4N3M0), Stage 4A (anyT, anyN and M1a/M1b), Stage 4B (anyT, anyN and M1c). where T1: <=3 cm; T2: >3 to <=5 cm; T3: >5 to <=7 cm; T4: >7cm. N0: not spread to regional LN; N1: spread to ipsilateral pulmonary or hilar nodes; N2: spread to ipsilateral mediastinal or subcarinal nodes; N3: spread to contralateral mediastinal, hilar, or supraclavicular nodes. M0: no distant metastasis; M1a: malignant pleural or pericardial effusion or pleural or pericardial nodules or separate tumor nodule(s) in a contralateral lobe; M1b: single extrathoracic metastasis; M1c= multiple extrathoracic metastases (1 or >1 organ). | FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). | Posted | | Count of Participants | | Participants | | Baseline (date of last non-missing measurement prior to dacomitinib initiation; from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months | | | | ID | Title | Description |
|---|
| OG000 | Dacomitinib 30 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. |
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| Primary | Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status: All Asian Participants | ECOG performance classified as: Grade 0: fully active, able to carry on all pre-disease performance without restriction; Grade 1: restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature; Grade 2: ambulatory and capable of all selfcare but unable to carry out any work activities, up and about more than 50% of waking hours; Grade 3: capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: completely disabled, cannot carry on selfcare and totally confined to bed or chair and Grade 5: dead. Higher score indicated worse health status. | FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). | Posted | | Count of Participants | | Participants | | Baseline (date of last non-missing measurement prior to dacomitinib initiation; from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months | | | | ID | Title | Description |
|---|
| OG000 | Dacomitinib 30 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG001 | Dacomitinib 45 mg | |
|
| Primary | Number of Participants Classified According to Type of EGFR Mutation: All Asian Participants | Number of participants classified according to type of EGFR mutation were reported in this outcome measure. One participant may have more than one mutation. Participants were classified into the following rows: EGFR exon 19 deletion, EGFR exon 21 L858R substitution, EGFR T790M mutation and other. | FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). | Posted | | Count of Participants | | Participants | | Baseline (date of last non-missing measurement prior to dacomitinib initiation; from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months | | | | ID | Title | Description |
|---|
| OG000 | Dacomitinib 30 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG001 | Dacomitinib 45 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG002 | Dacomitinib Other Dose |
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| Primary | Number of Participants Classified According to Number of Oral Dose Modifications: All Asian Participants | Number of participants with dacomitinib oral dose modification (any dose change) from initial dacomitinib therapy are presented in this outcome measure. Participants were classified into the following categories: no dose modification, one dose modification, two dose modifications and more than two dose modifications. | FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). | Posted | | Count of Participants | | Participants | | From start of dacomitinib treatment until discontinuation/end of treatment (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months | | | | ID | Title | Description |
|---|
| OG000 | Dacomitinib 30 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG001 | Dacomitinib 45 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG002 |
|
| Primary | Number of Participants Classified According to Number of Oral Dose Interruptions: All Asian Participants | Number of participants with dacomitinib dose interruption (dacomitinib treatment being temporarily stopped) were reported in this outcome measure. Participants were classified into the following categories: no dose interruption, one dose interruption, two dose interruptions and more than two dose interruptions. | FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). | Posted | | Count of Participants | | Participants | | From start of dacomitinib treatment until discontinuation/end of treatment (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months | | | | ID | Title | Description |
|---|
| OG000 | Dacomitinib 30 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG001 | Dacomitinib 45 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG002 |
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| Primary | Number of Participants With Any Oral Dose Discontinuation: All Asian Participants | Number of participants with dacomitinib dose discontinuation (dacomitinib treatment permanently stopped) were reported in this outcome measure. | FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). | Posted | | Count of Participants | | Participants | | From start of dacomitinib treatment until discontinuation/end of treatment (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months | | | | ID | Title | Description |
|---|
| OG000 | Dacomitinib 30 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG001 | Dacomitinib 45 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG002 | Dacomitinib Other Dose | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. |
|
| Primary | Duration of Dacomitinib Therapy: All Asian Participants | Duration of dacomitinib therapy (dacomitinib last dose date - dacomitinib initiation date + 1 day) was reported in this outcome measure. | FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). | Posted | | Median | Full Range | Months | | First dose of dacomitinib till discontinuation/ end of dacomitinib treatment (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months | | | | ID | Title | Description |
|---|
| OG000 | Dacomitinib 30 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG001 | Dacomitinib 45 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG002 | Dacomitinib Other Dose | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. |
|
| Primary | Time To Treatment Failure (TTF): All Asian Participants | TTF was defined as the time from date of dacomitinib initiation to date of dacomitinib permanent discontinuation (for any reason), first disease progression (PD), or death (from any cause), whichever came first. PD was defined as cancer worsening based on radiologist's interpretation of the imaging and/or clinician's assessment, and after initiation of first-line dacomitinib treatment. Participants who remained on dacomitinib without an event until end of follow-up were censored at the date of last known contact/visit date. Participants lost to follow-up were censored based on the last known contact/visit date. Kaplan-Meier method was used for analysis. | FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). | Posted | | Median | 95% Confidence Interval | Months | | From dacomitinib treatment initiation to dacomitinib discontinuation, PD or death due to any cause, whichever came first or censoring date (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months | | | | ID | Title | Description |
|---|
| OG000 | Dacomitinib 30 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG001 | Dacomitinib 45 mg | |
|
| Secondary | Progression-free Survival (PFS): All Asian Participants | PFS was defined as date of dacomitinib initiation to date of first PD or death from any cause, whichever came first. PD was defined as cancer worsening based on radiologist's interpretation of the imaging and/or clinician's assessment, and after initiation of first-line dacomitinib treatment. Participants without PD and remained alive (i.e. no date of death) until end of follow-up were censored at the date of last known contact/visit date. Participants lost to follow-up were censored based on the last known contact/visit date. Kaplan-Meier method was used for analysis. | FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). | Posted | | Median | 95% Confidence Interval | Months | | From dacomitinib treatment initiation to PD or death due to any cause, whichever came first or censoring date (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months | | | | ID | Title | Description |
|---|
| OG000 | Dacomitinib 30 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG001 | Dacomitinib 45 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. |
|
| Secondary | Number of Participants With Adverse Events (AEs): All Asian Participants | AE was any untoward medical occurrence in a participant or clinical investigation participant administered sponsor's product and which did not necessarily have a causal relationship with the product. | FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). | Posted | | Count of Participants | | Participants | | From dacomitinib treatment initiation to death or end of study whichever occurred first (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months | | | | ID | Title | Description |
|---|
| OG000 | Dacomitinib 30 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG001 | Dacomitinib 45 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG002 | Dacomitinib Other Dose | |
|
| Secondary | TTF: Chinese Participants With Common EGFR Mutation | TTF was defined as the time from date of dacomitinib initiation to date of dacomitinib permanent discontinuation (for any reason), first PD, or death (from any cause), whichever came first. PD was defined as cancer worsening based on radiologist's interpretation of the imaging and/or clinician's assessment, and after initiation of first-line dacomitinib treatment. Participants who remained on dacomitinib without an event until end of follow-up were censored at the date of last known contact/visit date. Participants lost to follow-up were censored based on the last known contact/visit date. Kaplan-Meier method was used for analysis. | FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). Here, "Overall Number of Participants Analyzed" signifies Chinese participants with common EGFR mutation evaluable for this outcome measure. | Posted | | Median | 95% Confidence Interval | Months | | From dacomitinib treatment initiation to dacomitinib discontinuation, PD or death due to any cause, whichever came first or censoring date (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months | | | | ID | Title | Description |
|---|
| OG000 | Dacomitinib 30 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG001 | Dacomitinib 45 mg |
|
| Secondary | PFS: Chinese Participants With Common EGFR Mutation | PFS was defined as date of dacomitinib initiation to date of first PD or death from any cause, whichever came first. PD was defined as cancer worsening based on radiologist's interpretation of the imaging and/or clinician's assessment, and after initiation of first-line dacomitinib treatment. Participants without PD and remained alive (i.e. no date of death) until end of follow-up were censored at the date of last known contact/visit date. Participants lost to follow-up were censored based on the last known contact/visit date. Kaplan-Meier method was used for analysis. | FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). Here, "Overall Number of Participants Analyzed" signifies Chinese participants with common EGFR mutation evaluable for this outcome measure. | Posted | | Median | 95% Confidence Interval | Months | | From dacomitinib treatment initiation to PD or death due to any cause, whichever came first or censoring date (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months | | | | ID | Title | Description |
|---|
| OG000 | Dacomitinib 30 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG001 | Dacomitinib 45 mg | |
|
| Secondary | Number of Participants With AEs: Chinese Participants With Common EGFR Mutation | AE was any untoward medical occurrence in a participant or clinical investigation participant administered sponsor's product and which did not necessarily have a causal relationship with the product. | FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). Here, "Overall Number of Participants Analyzed" signifies Chinese participants with common EGFR mutation evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | From dacomitinib treatment initiation to death or end of study whichever occurred first (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months | | | | ID | Title | Description |
|---|
| OG000 | Dacomitinib 30 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG001 | Dacomitinib 45 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG002 |
|
| Secondary | Number of Participants Classified According to Starting Dose of Dacomitinib as First-line Therapy: Chinese Participants With Common EGFR Mutation | Number of participants classified according to starting dose of dacomitinib (30 mg, 45 mg or other dose) as first-line in Chinese participants with common EGFR mutations are presented in this outcome measure. | FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). Here, "Overall Number of Participants Analyzed" signifies Chinese participants with common EGFR mutation evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | From start of dacomitinib treatment until discontinuation/end of treatment (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months | | | | ID | Title | Description |
|---|
| OG000 | Dacomitinib 30 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG001 | Dacomitinib 45 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | |
|
| Secondary | Number of Participants Without Oral Dose Modifications: Chinese Participants With Common EGFR Mutation | Number of participants without any dacomitinib dose modification (any dose change) from initial dacomitinib therapy in Chinese participants with common EGFR mutations are presented in this outcome measure. | FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). Here, "Overall Number of Participants Analyzed" signifies Chinese participants with common EGFR mutation evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | From start of dacomitinib treatment until discontinuation/end of treatment (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months | | | | ID | Title | Description |
|---|
| OG000 | Dacomitinib 30 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG001 | Dacomitinib 45 mg | Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included. | | OG002 |
|