| Primary | Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status | The 95% Confidence intervals were calculated using Clopper Pearson method for each country. | Tumour Evaluable Population | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | China | Subjects in China that meet I/E and population criteria. | | OG001 | Taiwan | Subjects in Taiwan that meet I/E and population criteria | | OG002 | South Korea | Subjects in South Korea that meet I/E and population criteria | | OG003 | Australia | Subjects in Australia that meet I/E and population criteria | | OG004 | Thailand | Subjects in Thailand that meet I/E and population criteria | | OG005 | Singapore | Subjects in Singapore that meet I/E and population criteria | | OG006 | Malaysia | Subjects in Malaysia that meet I/E and population criteria | | OG007 | Indonesia | Subjects in Indonesia that meet I/E and population criteria | | OG008 | Russia | Subjects in Russia that meet I/E and population criteria |
| | Units | Counts |
|---|
| Participants | - OG0001391
- OG001271
- OG00262
- OG003
|
| | Title | Denominators | Categories |
|---|
| Mutation Negative | | | Title | Measurements |
|---|
| - OG00059.2(56.6 to 61.8)
- OG00152.0(45.9 to 58.1)
- OG00277.4(65.0 to 87.1)
- OG003
|
|
| |
| Primary | Tumour EGFR Mutation by Subtype | Frequency distribution of subjects with a positive mutation status by the mutation subtype and country. | Tumour Evaluable Population | Posted | | Number | | Participants | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | China | Subjects in China that meet I/E and population criteria. | | OG001 | Taiwan | Subjects in Taiwan that meet I/E and population criteria | | OG002 | South Korea | Subjects in South Korea that meet I/E and population criteria | | OG003 | Australia | Subjects in Australia that meet I/E and population criteria | | OG004 | Thailand | Subjects in Thailand that meet I/E and population criteria | |
|
| Primary | Tumour EGFR Mutation Status by Histology | Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country. | Tumour Evaluable Population | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | China-Adenocarcinoma | Subjects in China that meet I/E and population criteria with a histological type of Adenocarcinoma. | | OG001 | China-Non-adenocarcinoma | Subjects in China that meet I/E and population criteria with a histological type of Non-Adenocarcinoma. | | OG002 | Taiwan-Adenocarcinoma | Subjects in Taiwan that meet I/E and population criteria with a histological type of Adenocarcinoma. | | OG003 | Taiwan-Non-adenocarcinoma | Subjects in Taiwan that meet I/E and population criteria with a histological type of Non-Adenocarcinoma. |
|
| Primary | Overall Plasma EGFR Mutation Status | Plasma samples were only performed in China, Taiwan, South Korea and Russia. The Confidence intervals were calculated using Clopper Pearson method for each country. | Plasma Evaluable Population | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | China | Subjects in China that meet I/E and population criteria. | | OG001 | Taiwan | Subjects in Taiwan that meet I/E and population criteria | | OG002 | South Korea | Subjects in South Korea that meet I/E and population criteria | | OG003 | Russia | Subjects in Russia that meet I/E and population criteria |
| |
| Primary | Plasma EGFR Mutation by Subtype | Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequency distribution of subjects with a positive mutation status by the mutation subtype and country. | Plasma Evaluable Population | Posted | | Number | | Participants | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | China | Subjects in China that meet I/E and population criteria. | | OG001 | Taiwan | Subjects in Taiwan that meet I/E and population criteria | | OG002 | South Korea | Subjects in South Korea that meet I/E and population criteria | | OG003 | Russia | Subjects in Russia that meet I/E and population criteria |
| |
| Primary | Plasma EGFR Mutation Status by Histology | Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country | Plasma Evaluable Population | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | China-Adenocarcinoma | Subjects in China that meet I/E and population criteria with a histological type of Adenocarcinoma. | | OG001 | China-Non-Adenocarcinoma | Subjects in China that meet I/E and population criteria with a histological type of Non-Adenocarcinoma. | | OG002 | Taiwan-Adenocarcinoma | Subjects in Taiwan that meet I/E and population criteria with a histological type of Adenocarcinoma. | | OG003 | Taiwan-Non-adenocarcinoma | Subjects in Taiwan that meet I/E and population criteria with a histological type of Non-Adenocarcinoma. |
|
| Secondary | Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples | Plasma samples were only performed in China, Taiwan, South Korea and Russia. | Tumour and Plasma Evaluable Population | Posted | | Number | | Percentage | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | China | Subjects in China that meet I/E and population criteria. | | OG001 | Taiwan | Subjects in Taiwan that meet I/E and population criteria | | OG002 | South Korea | Subjects in South Korea that meet I/E and population criteria | | OG003 | Russia | Subjects in Russia that meet I/E and population criteria |
| |
| Secondary | Sensitivity and Specificity of Comparison of Mutation Status Between Tumour and Plasma Samples | Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants only include those who had sensitivity and specificity tests performed. | Tumour and Plasma Evaluable Population | Posted | | Number | | Percentage | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | China - Sensitivity | Subjects in China that meet I/E and population criteria, who had a sensitivity test performed. | | OG001 | China - Specificty | Subjects in China that meet I/E and population criteria, who had a specificity test performed. | | OG002 | Taiwan - Sensitivity | Subjects in Taiwan that meet I/E and population criteria, who had a sensitivity test performed. | | OG003 | Taiwan - Specificity | Subjects in Taiwan that meet I/E and population criteria, who had a specificity test performed. | |
|
| Secondary | Predictive Values of Comparison of Mutation Status Between Tumour and Plasma Samples | Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants include only those who had Positive and Negative Predictive tests performed. | Tumour and Plasma Evaluable Population | Posted | | Number | | Percentage | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | China - Positive Predictive Value | Subjects in China that meet I/E and population criteria, who had a Positive Predictive test performed. | | OG001 | China - Negative Predictive Value | Subjects in China that meet I/E and population criteria, who had a Negative Predictive test performed. | | OG002 | Taiwan - Positive Predictive Value | Subjects in Taiwan that meet I/E and population criteria, who had a Positive Predictive test performed. | | OG003 | Taiwan - Negative Predictive Value | Subjects in Taiwan that meet I/E and population criteria, who had a Negative Predictive test performed. |
|
| Secondary | Tumour EGFR Mutation Testing | Frequencies of tumour EGFR mutation testing practices parameters. | | Posted | | Number | | Participants | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | China | Subjects in China that meet I/E and population criteria. | | OG001 | Taiwan | Subjects in Taiwan that meet I/E and population criteria | | OG002 | South Korea | Subjects in South Korea that meet I/E and population criteria | | OG003 | Australia | Subjects in Australia that meet I/E and population criteria | | OG004 | Thailand | Subjects in Thailand that meet I/E and population criteria | | OG005 |
|
| Secondary | Tumour EGFR Mutation Testing Rates | Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation. | | Posted | | Number | | Percentage of Participants | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | China | Subjects in China that meet I/E and population criteria. | | OG001 | Taiwan | Subjects in Taiwan that meet I/E and population criteria | | OG002 | South Korea | Subjects in South Korea that meet I/E and population criteria | | OG003 | Australia | Subjects in Australia that meet I/E and population criteria | | OG004 | Thailand | Subjects in Thailand that meet I/E and population criteria |
|
| Secondary | Tumour EGFR Mutation Testing Turnaround Time | Tumour EGFR mutation testing turnaround time is the number of days from the test request to getting the test result. | | Posted | | Mean | Standard Deviation | Time (Days) | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | China | Subjects in China that meet I/E and population criteria. | | OG001 | Taiwan | Subjects in Taiwan that meet I/E and population criteria | | OG002 | South Korea | Subjects in South Korea that meet I/E and population criteria | | OG003 | Australia | Subjects in Australia that meet I/E and population criteria | | OG004 | Thailand | Subjects in Thailand that meet I/E and population criteria |
|
| Secondary | Plasma EGFR Mutation Testing | Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequencies of plasma EGFR mutation testing practices parameters. | | Posted | | Number | | Participants | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | China | Subjects in China that meet I/E and population criteria. | | OG001 | Taiwan | Subjects in Taiwan that meet I/E and population criteria | | OG002 | South Korea | Subjects in South Korea that meet I/E and population criteria | | OG003 | Russia | Subjects in Russia that meet I/E and population criteria |
| |
| Secondary | Plasma EGFR Mutation Testing Rates | Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation. Plasma samples were only performed in China, Taiwan, South Korea and Russia. | | Posted | | Number | | Percentage of Participants | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | China | Subjects in China that meet I/E and population criteria. | | OG001 | Taiwan | Subjects in Taiwan that meet I/E and population criteria | | OG002 | South Korea | Subjects in South Korea that meet I/E and population criteria | | OG003 | Russia | Subjects in Russia that meet I/E and population criteria |
| |
| Secondary | Plasma EGFR Mutation Testing Turnaround Time | Plasma samples were only performed in China, Taiwan, South Korea and Russia. Plasma EGFR mutation testing turnaround time is the number of days from the test request to getting the test result. | | Posted | | Mean | Standard Deviation | Time (Days) | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | China | Subjects in China that meet I/E and population criteria | | OG001 | Taiwan | Subjects in Taiwan that meet I/E and population criteria | | OG002 | South Korea | Subjects in South Korea that meet I/E and population criteria | | OG003 | Russia | Subjects in Russia that meet I/E and population criteria |
| |
| Secondary | Demographics and Disease Characteristics by Tumour EGFR Mutation Status | Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry. | Tumour Evaluable Population | Posted | | Number | | Participants | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | EGFR Mutation Positive | Participants who were EGFR Mutation Positive for the analysis population. | | OG001 | EGFR Mutation Negative | Participants who were EGFR Mutation Negative for the analysis population. |
| |
| Secondary | Time Since First Non-small-cell Lung Carcinoma (NSCLC) Diagnosis by Tumor EGFR Mutation | Number of months since the first diagnosis of NSCLC from informed consent date. | Tumour Evaluable Population | Posted | | Mean | Standard Deviation | Months | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | EGFR Mutation Positive | Participants who were EGFR Mutation Positive for the analysis population. | | OG001 | EGFR Mutation Negative | Participants who were EGFR Mutation Negative for the analysis population. |
| |
| Secondary | Number of Organs With Metastasis by Tumour EGFR Mutation Status | Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included. | Tumour Evaluable Population | Posted | | Mean | Standard Deviation | Number | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | EGFR Mutation Positive | Participants who were EGFR Mutation Positive for the analysis population. | | OG001 | EGFR Mutation Negative | Participants who were EGFR Mutation Negative for the analysis population. |
| |
| Secondary | Demographics and Disease Characteristics by Plasma EGFR Mutation Status | Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry. | Plasma Evaluable Population | Posted | | Number | | Participants | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | EGFR Mutation Positive | Participants who were EGFR Mutation Positive for the analysis population. | | OG001 | EGFR Mutation Negative | Participants who were EGFR Mutation Negative for the analysis population. |
| |
| Secondary | Time Since First NSCLC Diagnosis by Plasma EGFR Mutation | Number of months since the first diagnosis of NSCLC from informed consent date. | Plasma Evaluable Population | Posted | | Mean | Standard Deviation | Months | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | EGFR Mutation Positive | Participants who were EGFR Mutation Positive for the analysis population. | | OG001 | EGFR Mutation Negative | Participants who were EGFR Mutation Negative for the analysis population. |
| |
| Secondary | Number of Organs With Metastasis by Plasma EGFR Mutation Status | Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included. | Plasma Evaluable Population | Posted | | Mean | Standard Deviation | Number | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | EGFR Mutation Positive | Participants who were EGFR Mutation Positive for the analysis population. | | OG001 | EGFR Mutation Negative | Participants who were EGFR Mutation Negative for the analysis population. |
| |
| Secondary | First Line Treatment Choice by Asia Pacific Country | | Tumour Evaluable Population | Posted | | Number | | Participants | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | China | Subjects in China that meet I/E and population criteria. | | OG001 | Taiwan | Subjects in Taiwan that meet I/E and population criteria | | OG002 | South Korea | Subjects in South Korea that meet I/E and population criteria | | OG003 | Australia | Subjects in Australia that meet I/E and population criteria | | OG004 | Thailand | Subjects in Thailand that meet I/E and population criteria | | OG005 | Singapore |
|
| Secondary | First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status | | Tumour Evaluable Population | Posted | | Number | | Participants | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | China-Mutation Status Positive | Subjects in China that meet I/E and population criteria, who had a Positive Mutation Status. | | OG001 | China-Mutation Status Negative | Subjects in China that meet I/E and population criteria, who had a Negative Mutation Status. | | OG002 | Taiwan-Mutation Status Positive | Subjects in Taiwan that meet I/E and population criteria, who had a Positive Mutation Status. | | OG003 | Taiwan-Mutation Status Negative | Subjects in Taiwan that meet I/E and population criteria, who had a Negative Mutation Status. | | OG004 | South Korea-Mutation Status Positive | |
|