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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1160-2242 | Other Grant/Funding Number | 112455 | |
| 2014-002694-11 | EudraCT Number |
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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non Small Cell Lung Cancer
This is a Phase III, double-blind, randomised study assessing the efficacy and safety of AZD9291 (80 mg orally, once daily) versus a standard of care (SoC) Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) (either gefitinib [250 mg orally, once daily] or erlotinib [150 mg orally, once daily]) in patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) that is known to be EGFR sensitising mutation (EGFRm) positive, treatment-naïve and eligible for first-line treatment with an EGFR-TKI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD9291+ placebo | Experimental | AZD9291 (80 mg or 40 mg orally, once daily) plus placebo Erlotinib (150mg or 100mg orally, once daily) or placebo Gefitinib (250 mg orally, once daily), in accordance with the randomization schedule. |
|
| Standard of Care + placebo AZD9291 | Active Comparator | Erlotinib (150 mg or 100 mg orally, once daily) or placebo Gefitinib (250 mg orally, once daily) plus placebo AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomisation schedule. Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were randomized to Standard of Care arm may have the option to receive open-label AZD9291 (crossover to active AZD9291). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD9291 80 mg/40 mg + placebo | Drug | The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression Free Survival (PFS) (Months) | Progression-free survival was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression and was used to assess the efficacy of single agent osimertinib compared with SoC EGFR-TKI therapy as measured by PFS. The primary endpoint of PFS was based on Investigator assessment. | At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression |
| Percentage of Participants in Progression Free Survival at 6, 12, and 18 Months | Progression-free survival was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression and was used to assess the efficacy of single agent osimertinib compared with SoC EGFR-TKI therapy as measured by PFS. | At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was defined as the number (%) of participants with measurable disease with at least 1 visit response of Complete response (CR) or Partial response (PR) and it was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy. ORR was based on Investigator assessment. | At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression |
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Inclusion Criteria:
Exclusion Criteria:
Treatment with any of the following:
Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of study drug.
Spinal cord compression, symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, have a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids.
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291.
Any of the following cardiac criteria:
Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
Involvement in the planning and/or conduct of the study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anaheim | California | 92801 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41166679 | Derived | Markovets A, Merino Vega D, Abbosh C, Quinn K, Chang K, Wienke S, Hartmaier R, Barrett JC, Hodgson D. Variability of Circulating Tumor DNA Levels in Plasma Samples From Patients With Advanced Non-Small-Cell Lung Cancer in the Absence of Treatment. JCO Precis Oncol. 2025 Oct;9:e2500287. doi: 10.1200/PO-25-00287. Epub 2025 Oct 30. | |
| 40311309 |
| Label | URL |
|---|---|
| Cancer | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
During the 28 day screening period, participants were enrolled based on the presence in their tumour of at least 1 of the 2 most frequent Epidermal growth factor receptor (EGFR) mutations. At the time of enrolment, all participants were required to provide biopsy tissue for central testing of the Exon 19 deletion (Ex19del) and L858R mutations
A total of 556 participants in Global cohort (out of 673 participants in Global and China cohorts) were randomized to treatment at 132 study centres in 29 countries. An additional 117 participants in 19 centres were enrolled into the China extension cohort only.
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| ID | Title | Description |
|---|---|---|
| FG000 | Osimertinib 80 mg (Global Cohort) | Randomized participants received Osimertinib 80 mg orally once daily (QD) |
| FG001 | SoC EGFR-TKI (Global Cohort) | Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 7, 2018 | Jun 13, 2018 |
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| Placebo Erlotinib 150/100mg | Drug | The initial dose of Placebo Erlotinib 150 mg once daily can be reduced to Placebo 100 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria. |
|
|
| Placebo Gefitinib 250 mg | Drug | The initial dose of Placebo Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria. |
|
|
| Erlotinib 150/100 mg | Drug | The initial dose of Erlotinib 150mg once daily can be reduced to 10 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria. Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were randomized to Standard of Care arm may have the option to receive open-label AZD9291 (crossover to active AZD9291). |
|
|
| Gefitinib 250 mg | Drug | The initial dose of Gefitinib 250mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria. Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were randomized to Standard of Care arm may have the option to receive open-label AZD9291 (crossover to active AZD9291). |
|
|
| Placebo AZD9291 80 mg/ 40 mg | Drug | The initial dose of Placebo AZD9291 80 mg once daily can be reduced to Placebo AZD9291 40 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria. |
|
| Duration of Response (DoR) | Duration of response was defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression and was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy. | At baseline and every 6 weeks for the first 18 months and then every 12 weeks until objective disease progression |
| Disease Control Rate (DCR) | The DCR was defined as the percentage of participants who had a best overall response (BOR) of Complete response (CR), Partial response (PR) or Stable disease (SD) ≥6 weeks prior to any Progressive disease (PD) event and was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy. | At baseline and every 6 weeks for the first 18 months and then every 12 weeks until objective disease progression |
| Depth of Response | The Depth of response was defined as the relative change in the sum of the longest diameters of Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions (TLs) at the nadir, in the absence of new lesions (NLs) or progression of Non-target lesions (NTLs), compared to baseline and was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy | At baseline and every 6 weeks for the first 18 months and then every 12 weeks until objective disease progression |
| Overall Survival (OS)- Number of Participants With an Event | Overall survival was defined as the time from the date of randomisation until death from any cause and was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy | From first dose to end of study or date of death from any cause, whichever comes first, assessed every 6 weeks (approximately 29 months) |
| Plasma Concentrations of AZD9291 | To characterise the pharmacokinetics (PK) of osimertinib | Blood samples collected from each participant at pre-dose, 0.5 to 2 hours, and 3 to 5 hours post-dose on Day 1 Cycle 1, and every other cycle thereafter up to and including Cycle 13 (approximately 9 months) |
| Plasma Concentrations of Metabolites AZ5104 | To characterise the pharmacokinetics (PK) of osimertinib metabolite AZ5104. | Blood samples collected from each participant at pre-dose, 0.5 to 2 hours, and 3 to 5 hours post-dose on Day 1 Cycle 1, and every other cycle thereafter up to and including Cycle 13 (approximately 9 months) |
| Plasma Concentrations of Metabolite AZ7550 | To characterise the pharmacokinetics (PK) of osimertinib metabolite AZ7550. | Blood samples collected from each participant at pre-dose, 0.5 to 2 hours, and 3 to 5 hours post-dose on Day 1 Cycle 1, and every other cycle thereafter up to and including Cycle 13 (approximately 9 months) |
| Participants Reported Outcome by Cancer Therapy Satisfaction Questionnaire 16 Items (CTSQ-16 Questionnaire) | The CTSQ-16 was a 16-item questionnaire measuring 3 domains related to participant's satisfaction with cancer therapy: Expectations of therapy, Feelings about side effects, and Satisfaction with therapy. Scores ranged from 0 to 100 for each domain, with a higher score associated with the best outcome on each domain. The three domains of interest were separately analysed using an ANCOVA stratified by race (Asian versus Non-Asian) and mutation type (Ex19del versus L858R). The results of the analyses were presented in terms of mean together with standard deviation. | Questionnaire completed in cycle 2 and 3, prior to Week 6 scan (approximately 2 months) |
| Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) Questionnaires Lung Cancer 13 (QLQ-LC13) | The EORTC QLQ-LC13 was a lung-cancer-specific module comprising 13 questions to assess lung cancer symptoms (cough, haemoptysis, dyspnoea, and site-specific pain); treatment related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia); and pain medication. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items. Higher scores on the global health status/QoL and functioning scales indicated better health status/QoL and function. Higher scores on the symptoms scales indicated greater symptom burden. The analysis was performed using a Mixed-effects model for repeated measures analysis on the change from baseline in PRO symptom score at each visit up to 9 months (281 days), including participants, treatment, visit and treatment by visit interaction as explanatory variables, the baseline PRO score as a covariate along with the baseline PRO score by visit interaction, using an unstructured covariance structure. | Questionnaires completed at baseline, first 9 months, and at week 1, 2, 3, 4, 5, 6, 12, 18, 24, 30 and 36 |
| Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30) | The EORTC QLQ-C30 cancer-specific questionnaire consisted of 30 questions, combined to produce 5 functional scales, 3 symptom scales, 6 individual items, and a global measure of health status/QoL. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, the functional scales, and the global health status/QoL scale in the EORTC QLQ-C30. Higher scores on the global health status and functioning scales indicated better health status/function. Higher scores on the symptoms scales indicated greater symptom burden. The analysis was performed using a Mixed-effects model for repeated measures analysis on the change from baseline in PRO symptom score at each visit up to 9 months (281 days), including participants, treatment, visit and treatment by visit interaction as explanatory variables, the baseline PRO score as a covariate along with the baseline PRO score by visit interaction, using an unstructured covariance structure. | Questionnaires completed at baseline, first 9 months, and at week 6, 12, 18, 24, 30, and 36. |
| Santa Rosa |
| California |
| 95403 |
| United States |
| Research Site | West Hills | California | 91307 | United States |
| Research Site | Tampa | Florida | 33612 | United States |
| Research Site | Atlanta | Georgia | 30318 | United States |
| Research Site | Atlanta | Georgia | 30322 | United States |
| Research Site | Marietta | Georgia | 30060 | United States |
| Research Site | Louisville | Kentucky | 40202 | United States |
| Research Site | Bethesda | Maryland | 20817 | United States |
| Research Site | Boston | Massachusetts | 02215 | United States |
| Research Site | Minneapolis | Minnesota | 55407 | United States |
| Research Site | Lebanon | New Hampshire | 03756 | United States |
| Research Site | Salisbury | North Carolina | 28144 | United States |
| Research Site | Burlington | Vermont | 05401 | United States |
| Research Site | Camperdown | 2050 | Australia |
| Research Site | Chermside | 4032 | Australia |
| Research Site | Clayton | 3168 | Australia |
| Research Site | Heidelberg | 3084 | Australia |
| Research Site | Kogarah | 2217 | Australia |
| Research Site | Nedlands | 6009 | Australia |
| Research Site | Woolloongabba | 4102 | Australia |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Liège | 4000 | Belgium |
| Research Site | Roeselare | 8800 | Belgium |
| Research Site | Porto Alegre | 90610-000 | Brazil |
| Research Site | Sofia | 1330 | Bulgaria |
| Research Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Research Site | Hamilton | Ontario | L8V 5C2 | Canada |
| Research Site | Ottawa | Ontario | K1H 8L6 | Canada |
| Research Site | Toronto | Ontario | M4N 3M5 | Canada |
| Research Site | Toronto | Ontario | M5G 1X5 | Canada |
| Research Site | Toronto | Ontario | M5G 2M9 | Canada |
| Research Site | Beijing | 100071 | China |
| Research Site | Beijing | 100853 | China |
| Research Site | Changchun | 130012 | China |
| Research Site | Changchun | 130021 | China |
| Research Site | Chongqing | 400037 | China |
| Research Site | Chongqing | 400038 | China |
| Research Site | Chongqing | 400042 | China |
| Research Site | Fuzhou | 350025 | China |
| Research Site | Guangzhou | 510080 | China |
| Research Site | Hangzhou | 310022 | China |
| Research Site | Nanjing | 210029 | China |
| Research Site | Nanning | 530021 | China |
| Research Site | Shanghai | 200433 | China |
| Research Site | Shenyang | 110001 | China |
| Research Site | Suzhou | 215006 | China |
| Research Site | Ürümqi | 830000 | China |
| Research Site | Wuhan | 430071 | China |
| Research Site | Xi'an | 710038 | China |
| Research Site | Xi'an | 710061 | China |
| Research Site | Yangzhou | 225001 | China |
| Research Site | Ostrava | 708 52 | Czechia |
| Research Site | Caen | F-14033 | France |
| Research Site | Créteil | 94010 | France |
| Research Site | Lyon | 69373 | France |
| Research Site | Nantes | 44202 | France |
| Research Site | Toulon Naval | 83800 | France |
| Research Site | Villejuif | 94805 | France |
| Research Site | Bad Berka | 99437 | Germany |
| Research Site | Berlin | 13125 | Germany |
| Research Site | Gauting | 82131 | Germany |
| Research Site | Halle | 06120 | Germany |
| Research Site | Heidelberg | 69126 | Germany |
| Research Site | Karlsruhe | 76137 | Germany |
| Research Site | Lübeck | 23538 | Germany |
| Research Site | München | 81925 | Germany |
| Research Site | Villingen-Schwenningen | 78052 | Germany |
| Research Site | Farkasgyepü | 8582 | Hungary |
| Research Site | Gyöngyös - Mátraháza | 3200 | Hungary |
| Research Site | Miskolc | 3529 | Hungary |
| Research Site | Székesfehérvár | 8000 | Hungary |
| Research Site | Tatabánya | 2800 | Hungary |
| Research Site | Zalaegerszeg | 8900 | Hungary |
| Research Site | Haifa | 31999 | Israel |
| Research Site | Kfar Saba | 4428164 | Israel |
| Research Site | Petah Tikva | 49100 | Israel |
| Research Site | Tel Litwinsky | 52621 | Israel |
| Research Site | Cremona | 26100 | Italy |
| Research Site | Lecce | 73100 | Italy |
| Research Site | Lecco | 23900 | Italy |
| Research Site | Orbassano | 10043 | Italy |
| Research Site | Parma | 43126 | Italy |
| Research Site | Roma | 00144 | Italy |
| Research Site | Sondrio | 23100 | Italy |
| Research Site | Terni | 05100 | Italy |
| Research Site | Chūōku | 104-0045 | Japan |
| Research Site | Fukuoka | 812-8582 | Japan |
| Research Site | Hirakata-shi | 573-1191 | Japan |
| Research Site | Kanazawa | 920-8641 | Japan |
| Research Site | Kashiwa | 277-8577 | Japan |
| Research Site | Kobe | 650-0047 | Japan |
| Research Site | Matsuyama | 791-0280 | Japan |
| Research Site | Natori-shi | 981-1293 | Japan |
| Research Site | Osaka | 541-8567 | Japan |
| Research Site | Osakasayama-shi | 589-8511 | Japan |
| Research Site | Sagamihara-shi | 252-0375 | Japan |
| Research Site | Sakaishi | 591-8555 | Japan |
| Research Site | Sendai | 980-0873 | Japan |
| Research Site | Sunto-gun | 411-8777 | Japan |
| Research Site | Yokohama | 232-0024 | Japan |
| Research Site | Yokohama | 236-0051 | Japan |
| Research Site | Yokohama | 240-8555 | Japan |
| Research Site | Yokohama | 241-8515 | Japan |
| Research Site | Kuala Lumpur | 59100 | Malaysia |
| Research Site | Kuantan | 25100 | Malaysia |
| Research Site | Kuching | 93586 | Malaysia |
| Research Site | Cebu | 6000 | Philippines |
| Research Site | Manila | 1000 | Philippines |
| Research Site | Quezon City | 1100 | Philippines |
| Research Site | Brzozoów | 36-200 | Poland |
| Research Site | Otwock | 05-400 | Poland |
| Research Site | Poznan | 60-569 | Poland |
| Research Site | Szczecin | 70-891 | Poland |
| Research Site | Warsaw | 02-781 | Poland |
| Research Site | Amadora | 2720-276 | Portugal |
| Research Site | Lisbon | 1769-001 | Portugal |
| Research Site | Porto | 4200-072 | Portugal |
| Research Site | Vila Nova de Gaia | 4434-502 | Portugal |
| Research Site | Bucharest | 022328 | Romania |
| Research Site | Bucharest | 050098 | Romania |
| Research Site | Craiova | 200347 | Romania |
| Research Site | Saint Petersburg | 197022 | Russia |
| Research Site | Saint Petersburg | 197758 | Russia |
| Research Site | Saint Petersburg | 198255 | Russia |
| Research Site | Cheongju-si | 28644 | South Korea |
| Research Site | Incheon | 405-760 | South Korea |
| Research Site | Seongnam-si | 13620 | South Korea |
| Research Site | Seoul | 02841 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 06591 | South Korea |
| Research Site | Seoul | 5030 | South Korea |
| Research Site | A Coruña | 15006 | Spain |
| Research Site | Barcelona | 08041 | Spain |
| Research Site | Barcelona | 08221 | Spain |
| Research Site | Barcelona | 08907 | Spain |
| Research Site | Lleida | 25198 | Spain |
| Research Site | Lugo | 27003 | Spain |
| Research Site | Madrid | 28040 | Spain |
| Research Site | Málaga | 29010 | Spain |
| Research Site | Seville | 41014 | Spain |
| Research Site | Zaragoza | 50009 | Spain |
| Research Site | Linköping | 581 85 | Sweden |
| Research Site | Lucerne | 6000 | Switzerland |
| Research Site | Winterthur | 8401 | Switzerland |
| Research Site | Zurich | 8091 | Switzerland |
| Research Site | Kaohsiung City | 833 | Taiwan |
| Research Site | Taichung | 402 | Taiwan |
| Research Site | Tainan | 704 | Taiwan |
| Research Site | Tainan | 73657 | Taiwan |
| Research Site | Taoyuan City | 333 | Taiwan |
| Research Site | Bangkok | 10330 | Thailand |
| Research Site | Bangkok | 10400 | Thailand |
| Research Site | Bangkok | 10700 | Thailand |
| Research Site | Hat Yai | 90110 | Thailand |
| Research Site | Muang | 50200 | Thailand |
| Research Site | Ankara | 6500 | Turkey (Türkiye) |
| Research Site | Istanbul | 34069 | Turkey (Türkiye) |
| Research Site | Izmir | 35100 | Turkey (Türkiye) |
| Research Site | Dnipro | 49102 | Ukraine |
| Research Site | Kryvyi Rih | 50048 | Ukraine |
| Research Site | Lviv | 79031 | Ukraine |
| Research Site | Sumy | 40022 | Ukraine |
| Research Site | Edinburgh | EH4 2XU | United Kingdom |
| Research Site | London | NW1 2BU | United Kingdom |
| Research Site | Maidstone | ME16 9QQ | United Kingdom |
| Research Site | Withington | M20 4BX | United Kingdom |
| Research Site | Hanoi | 100000 | Vietnam |
| Research Site | Hanoi | 10000 | Vietnam |
| Research Site | Ho Chi Minh City | 70000 | Vietnam |
| Murat-Onana ML, Ramalingam SS, Janne PA, Gray JE, Ahn MJ, John T, Yatabe Y, Huang X, Rukazenkov Y, Javey M, Brown H, Li-Sucholeiki X. EGFR mutation testing across the osimertinib clinical program. Lung Cancer. 2025 Jun;204:108549. doi: 10.1016/j.lungcan.2025.108549. Epub 2025 Apr 18. |
| 39029876 | Derived | Gray JE, Markovets A, Reungwetwattana T, Majem M, Nogami N, Peled N, Lee JS, Cho BC, Chewaskulyong B, John T, Han JY, Sebastian M, Todd A, Rukazenkov Y, Barrett C, Chmielecki J, Lee SM, Ramalingam SS, Hartmaier R. Longitudinal Analyses of Circulating Tumor DNA for the Detection of EGFR Mutation-Positive Advanced NSCLC Progression During Treatment: Data From FLAURA and AURA3. J Thorac Oncol. 2024 Nov;19(11):1525-1538. doi: 10.1016/j.jtho.2024.07.008. Epub 2024 Jul 17. |
| 38539415 | Derived | Viray H, Piper-Vallillo AJ, Widick P, Academia E, Shea M, Rangachari D, VanderLaan PA, Kobayashi SS, Costa DB. A Real-World Study of Patient Characteristics and Clinical Outcomes in EGFR Mutated Lung Cancer Treated with First-Line Osimertinib: Expanding the FLAURA Trial Results into Routine Clinical Practice. Cancers (Basel). 2024 Mar 7;16(6):1079. doi: 10.3390/cancers16061079. |
| 38010260 | Derived | Johnson M, Serra Traynor C, Vishwanathan K, Overend P, Hartmaier R, Markovets A, Chmielecki J, Mugundu GM, Barrett JC, Tomkinson H, Ramalingam SS. Longitudinal Circulating Tumor DNA Modeling to Predict Disease Progression in First-Line Mutant Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer. Clin Pharmacol Ther. 2024 Feb;115(2):349-360. doi: 10.1002/cpt.3113. Epub 2023 Dec 21. |
| 35099678 | Derived | Walding A, Skaltsa K, Casamayor M, Ryden A. Time to deterioration of patient-reported outcomes in non-small cell lung cancer: exploring different definitions. Qual Life Res. 2022 Aug;31(8):2535-2543. doi: 10.1007/s11136-022-03088-0. Epub 2022 Jan 31. |
| 33544337 | Derived | Cheng Y, He Y, Li W, Zhang HL, Zhou Q, Wang B, Liu C, Walding A, Saggese M, Huang X, Fan M, Wang J, Ramalingam SS. Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study. Target Oncol. 2021 Mar;16(2):165-176. doi: 10.1007/s11523-021-00794-6. Epub 2021 Feb 5. |
| 31838405 | Derived | Leighl NB, Karaseva N, Nakagawa K, Cho BC, Gray JE, Hovey T, Walding A, Ryden A, Novello S. Patient-reported outcomes from FLAURA: Osimertinib versus erlotinib or gefitinib in patients with EGFR-mutated advanced non-small-cell lung cancer. Eur J Cancer. 2020 Jan;125:49-57. doi: 10.1016/j.ejca.2019.11.006. Epub 2019 Dec 12. |
| 31751012 | Derived | Ramalingam SS, Vansteenkiste J, Planchard D, Cho BC, Gray JE, Ohe Y, Zhou C, Reungwetwattana T, Cheng Y, Chewaskulyong B, Shah R, Cobo M, Lee KH, Cheema P, Tiseo M, John T, Lin MC, Imamura F, Kurata T, Todd A, Hodge R, Saggese M, Rukazenkov Y, Soria JC; FLAURA Investigators. Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2020 Jan 2;382(1):41-50. doi: 10.1056/NEJMoa1913662. Epub 2019 Nov 21. |
| 31605792 | Derived | Brown H, Vansteenkiste J, Nakagawa K, Cobo M, John T, Barker C, Kohlmann A, Todd A, Saggese M, Chmielecki J, Markovets A, Scott M, Ramalingam SS. Programmed Cell Death Ligand 1 Expression in Untreated EGFR Mutated Advanced NSCLC and Response to Osimertinib Versus Comparator in FLAURA. J Thorac Oncol. 2020 Jan;15(1):138-143. doi: 10.1016/j.jtho.2019.09.009. Epub 2019 Oct 9. |
| 31439584 | Derived | Gray JE, Okamoto I, Sriuranpong V, Vansteenkiste J, Imamura F, Lee JS, Pang YK, Cobo M, Kasahara K, Cheng Y, Nogami N, Cho EK, Su WC, Zhang G, Huang X, Li-Sucholeiki X, Lentrichia B, Dearden S, Jenkins S, Saggese M, Rukazenkov Y, Ramalingam SS. Tissue and Plasma EGFR Mutation Analysis in the FLAURA Trial: Osimertinib versus Comparator EGFR Tyrosine Kinase Inhibitor as First-Line Treatment in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer. Clin Cancer Res. 2019 Nov 15;25(22):6644-6652. doi: 10.1158/1078-0432.CCR-19-1126. Epub 2019 Aug 22. |
| 30659024 | Derived | Planchard D, Boyer MJ, Lee JS, Dechaphunkul A, Cheema PK, Takahashi T, Gray JE, Tiseo M, Ramalingam SS, Todd A, McKeown A, Rukazenkov Y, Ohe Y. Postprogression Outcomes for Osimertinib versus Standard-of-Care EGFR-TKI in Patients with Previously Untreated EGFR-mutated Advanced Non-Small Cell Lung Cancer. Clin Cancer Res. 2019 Apr 1;25(7):2058-2063. doi: 10.1158/1078-0432.CCR-18-3325. Epub 2019 Jan 18. |
| 30508196 | Derived | Ohe Y, Imamura F, Nogami N, Okamoto I, Kurata T, Kato T, Sugawara S, Ramalingam SS, Uchida H, Hodge R, Vowler SL, Walding A, Nakagawa K. Osimertinib versus standard-of-care EGFR-TKI as first-line treatment for EGFRm advanced NSCLC: FLAURA Japanese subset. Jpn J Clin Oncol. 2019 Jan 1;49(1):29-36. doi: 10.1093/jjco/hyy179. |
| 29151359 | Derived | Soria JC, Ohe Y, Vansteenkiste J, Reungwetwattana T, Chewaskulyong B, Lee KH, Dechaphunkul A, Imamura F, Nogami N, Kurata T, Okamoto I, Zhou C, Cho BC, Cheng Y, Cho EK, Voon PJ, Planchard D, Su WC, Gray JE, Lee SM, Hodge R, Marotti M, Rukazenkov Y, Ramalingam SS; FLAURA Investigators. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Jan 11;378(2):113-125. doi: 10.1056/NEJMoa1713137. Epub 2017 Nov 18. |
| Lung Cancer | View source |
| Erlotinib | View source |
| FDA Drug and Device Resources | View source |
| Gefitinib | View source |
| EGFR mutation | View source |
| Related Info | View source |
| SAP | View source |
| Redacted CSR | View source |
| Redacted CSR addendum | View source |
| FG002 | Osimertinib 80 mg (China Cohort) | Randomized participants received Osimertinib 80 mg orally once daily (QD) |
| FG003 | SoC EGFR-TKI (China Cohort) | Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD. |
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| COMPLETED | Participants ongoing study treatment at data cut-off |
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| NOT COMPLETED |
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There were 12 participants who were in both the Global and China Extension Osimertinib Arm and 7 participants in both the Global and China Extension SoC EGFR-TKI arm.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Global + China Extension Osimertinib Arm | All participants who were enrolled in Osimertinib Arm for either the global or China Extension study. |
| BG001 | Global + China Extension SoC EGFR-TKI Arm | All participants who were enrolled in SoC EGFR-TKI Arm for either the Global or China Extension study |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Each study is reported in a seprate row. There were 12 participants who were in both the Global and China Extension Osimertinib Arm, and 7 particicpants in both the Global and China Extension SoC EGFR-TKI arm. | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Each study is reported in a seprate row. There were 12 participants who were in both the Global and China Extension Osimertinib Arm, and 7 particicpants in both the Global and China Extension SoC EGFR-TKI arm. | Count of Participants | Participants |
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| Race (NIH/OMB) | Each study is reported in a seprate row. There were 12 participants who were in both the Global and China Extension Osimertinib Arm, and 7 particicpants in both the Global and China Extension SoC EGFR-TKI arm. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Each study is reported in a seprate row. There were 12 participants who were in both the Global and China Extension Osimertinib Arm, and 7 particicpants in both the Global and China Extension SoC EGFR-TKI arm. | Count of Participants | Participants |
| |||||||||||||||
| Smoking status | Each study is reported in a seprate row. There were 12 participants who were in both the Global and China Extension Osimertinib Arm, and 7 particicpants in both the Global and China Extension SoC EGFR-TKI arm. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Median Progression Free Survival (PFS) (Months) | Progression-free survival was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression and was used to assess the efficacy of single agent osimertinib compared with SoC EGFR-TKI therapy as measured by PFS. The primary endpoint of PFS was based on Investigator assessment. | The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed. | Posted | Median | 95% Confidence Interval | Months | At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression |
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| Primary | Percentage of Participants in Progression Free Survival at 6, 12, and 18 Months | Progression-free survival was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression and was used to assess the efficacy of single agent osimertinib compared with SoC EGFR-TKI therapy as measured by PFS. | The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed. | Posted | Number | Percentage of Participants | At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression |
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| Secondary | Objective Response Rate (ORR) | ORR was defined as the number (%) of participants with measurable disease with at least 1 visit response of Complete response (CR) or Partial response (PR) and it was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy. ORR was based on Investigator assessment. | The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed. | Posted | Number | 95% Confidence Interval | Percentage of participants | At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression |
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| Secondary | Duration of Response (DoR) | Duration of response was defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression and was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy. | The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed. | Posted | Median | 95% Confidence Interval | Months | At baseline and every 6 weeks for the first 18 months and then every 12 weeks until objective disease progression |
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| Secondary | Disease Control Rate (DCR) | The DCR was defined as the percentage of participants who had a best overall response (BOR) of Complete response (CR), Partial response (PR) or Stable disease (SD) ≥6 weeks prior to any Progressive disease (PD) event and was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy. | The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed. | Posted | Number | 95% Confidence Interval | Percentage of participants | At baseline and every 6 weeks for the first 18 months and then every 12 weeks until objective disease progression |
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| Secondary | Depth of Response | The Depth of response was defined as the relative change in the sum of the longest diameters of Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions (TLs) at the nadir, in the absence of new lesions (NLs) or progression of Non-target lesions (NTLs), compared to baseline and was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy | The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed. | Posted | Mean | Standard Deviation | percentage of change | At baseline and every 6 weeks for the first 18 months and then every 12 weeks until objective disease progression |
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| Secondary | Overall Survival (OS)- Number of Participants With an Event | Overall survival was defined as the time from the date of randomisation until death from any cause and was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy | The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed. | Posted | Count of Participants | Participants | From first dose to end of study or date of death from any cause, whichever comes first, assessed every 6 weeks (approximately 29 months) |
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| Secondary | Plasma Concentrations of AZD9291 | To characterise the pharmacokinetics (PK) of osimertinib | The pharmacokinetic analysis set (osimertinib arm only) was defined as participants in the FAS who had at least 1 evaluable PK concentration and who had no detectable pre-dose osimertinib concentrations above the lower limit of quantitation (LLQ) on Cycle 1 Day 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nano moles | Blood samples collected from each participant at pre-dose, 0.5 to 2 hours, and 3 to 5 hours post-dose on Day 1 Cycle 1, and every other cycle thereafter up to and including Cycle 13 (approximately 9 months) |
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| Secondary | Plasma Concentrations of Metabolites AZ5104 | To characterise the pharmacokinetics (PK) of osimertinib metabolite AZ5104. | The pharmacokinetic analysis set (osimertinib arm only) was defined as participants in the FAS who had at least 1 evaluable PK concentration and who had no detectable pre-dose osimertinib concentrations above the lower limit of quantitation (LLQ) on Cycle 1 Day 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nano moles | Blood samples collected from each participant at pre-dose, 0.5 to 2 hours, and 3 to 5 hours post-dose on Day 1 Cycle 1, and every other cycle thereafter up to and including Cycle 13 (approximately 9 months) |
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| Secondary | Plasma Concentrations of Metabolite AZ7550 | To characterise the pharmacokinetics (PK) of osimertinib metabolite AZ7550. | The pharmacokinetic analysis set (osimertinib arm only) was defined as participants in the FAS who had at least 1 evaluable PK concentration and who had no detectable pre-dose osimertinib concentrations above the lower limit of quantitation (LLQ) on Cycle 1 Day 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nano moles | Blood samples collected from each participant at pre-dose, 0.5 to 2 hours, and 3 to 5 hours post-dose on Day 1 Cycle 1, and every other cycle thereafter up to and including Cycle 13 (approximately 9 months) |
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| Secondary | Participants Reported Outcome by Cancer Therapy Satisfaction Questionnaire 16 Items (CTSQ-16 Questionnaire) | The CTSQ-16 was a 16-item questionnaire measuring 3 domains related to participant's satisfaction with cancer therapy: Expectations of therapy, Feelings about side effects, and Satisfaction with therapy. Scores ranged from 0 to 100 for each domain, with a higher score associated with the best outcome on each domain. The three domains of interest were separately analysed using an ANCOVA stratified by race (Asian versus Non-Asian) and mutation type (Ex19del versus L858R). The results of the analyses were presented in terms of mean together with standard deviation. | The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed. | Posted | Mean | Standard Deviation | Unit on scale | Questionnaire completed in cycle 2 and 3, prior to Week 6 scan (approximately 2 months) |
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| Secondary | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) Questionnaires Lung Cancer 13 (QLQ-LC13) | The EORTC QLQ-LC13 was a lung-cancer-specific module comprising 13 questions to assess lung cancer symptoms (cough, haemoptysis, dyspnoea, and site-specific pain); treatment related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia); and pain medication. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items. Higher scores on the global health status/QoL and functioning scales indicated better health status/QoL and function. Higher scores on the symptoms scales indicated greater symptom burden. The analysis was performed using a Mixed-effects model for repeated measures analysis on the change from baseline in PRO symptom score at each visit up to 9 months (281 days), including participants, treatment, visit and treatment by visit interaction as explanatory variables, the baseline PRO score as a covariate along with the baseline PRO score by visit interaction, using an unstructured covariance structure. | The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed. | Posted | Least Squares Mean | 95% Confidence Interval | Unit on scale | Questionnaires completed at baseline, first 9 months, and at week 1, 2, 3, 4, 5, 6, 12, 18, 24, 30 and 36 |
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| Secondary | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30) | The EORTC QLQ-C30 cancer-specific questionnaire consisted of 30 questions, combined to produce 5 functional scales, 3 symptom scales, 6 individual items, and a global measure of health status/QoL. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, the functional scales, and the global health status/QoL scale in the EORTC QLQ-C30. Higher scores on the global health status and functioning scales indicated better health status/function. Higher scores on the symptoms scales indicated greater symptom burden. The analysis was performed using a Mixed-effects model for repeated measures analysis on the change from baseline in PRO symptom score at each visit up to 9 months (281 days), including participants, treatment, visit and treatment by visit interaction as explanatory variables, the baseline PRO score as a covariate along with the baseline PRO score by visit interaction, using an unstructured covariance structure. | The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed. | Posted | Least Squares Mean | 95% Confidence Interval | Unit on scale | Questionnaires completed at baseline, first 9 months, and at week 6, 12, 18, 24, 30, and 36. |
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All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Osimertinib 80 mg (Global Cohort) | Randomized participants received Osimertinib 80 mg orally once daily (QD) | 155 | 279 | 74 | 279 | 273 | 279 |
| EG001 | SoC EGFR-TKI (Global Cohort) | Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD. | 166 | 277 | 76 | 277 | 271 | 277 |
| EG002 | Osimertinib 80 mg (China Cohort) | Randomized participants received Osimertinib 80 mg orally once daily (QD) | 45 | 71 | 25 | 71 | 70 | 71 |
| EG003 | SoC EGFR-TKI (China Cohort) | Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD. | 44 | 65 | 12 | 65 | 64 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal abscess | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Clostridial infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Endocarditis | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Febrile infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection viral | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Perineal abscess | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Pleural infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Rectal abscess | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Salmonella bacteraemia | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Non-systematic Assessment |
| |
| Histiocytic necrotising lymphadenitis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Non-systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Non-systematic Assessment |
| |
| Ovarian fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | 20.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | 20.0 | Non-systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | 20.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 20.0 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | 20.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 20.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | 20.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 20.0 | Non-systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | 20.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 20.0 | Non-systematic Assessment |
| |
| Brain oedema | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | 20.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | 20.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | 20.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 20.0 | Non-systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | 20.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | 20.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 20.0 | Non-systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | 20.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 20.0 | Non-systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | 20.0 | Non-systematic Assessment |
| |
| Aortic dissection | Vascular disorders | 20.0 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | 20.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 20.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | 20.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | 20.0 | Non-systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | 20.0 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | 20.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Tonsillolith | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | 20.0 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 20.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 20.0 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | 20.0 | Non-systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | 20.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | 20.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | 20.0 | Non-systematic Assessment |
| |
| Condition aggravated | General disorders | 20.0 | Non-systematic Assessment |
| |
| Death | General disorders | 20.0 | Non-systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | 20.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | 20.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | 20.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | 20.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | 20.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Procedural pneumothorax | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Blood disorder | Blood and lymphatic system disorders | 20.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 20.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 20.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | 20.0 | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | 20.0 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | 20.0 | Non-systematic Assessment |
| |
| Adenoviral upper respiratory infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Poisoning | Injury, poisoning and procedural complications | 20.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 20.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | 20.0 | Non-systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | 20.0 | Non-systematic Assessment |
| |
| Cerebral ventricle dilatation | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | 20.0 | Non-systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | 20.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Hepatitis C | Hepatobiliary disorders | 20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 20.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | 20.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | 20.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 20.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | 20.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | 20.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | 20.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | 20.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | 20.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 20.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | 20.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 20.0 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 20.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 20.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 20.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | 20.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 20.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | 20.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 20.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 20.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 20.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Blood albumin decreased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | 20.0 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | 20.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | 20.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 20.0 | Non-systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | 20.0 | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | 20.0 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | 20.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 20.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | 20.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | 20.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 20.0 | Non-systematic Assessment |
|
There were 19 Chinese participants who were included in both the global and China cohort which gives a total of 692 participants instead of a total of 673 participants.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Leader | AstraZeneca AB | +46 766 346712 | ClinicalTrialTransparency@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2017 | Jun 13, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000596361 | osimertinib |
| D000069347 | Erlotinib Hydrochloride |
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| China Cohort |
|
|
|
| China Cohort |
|
|
|
| China Cohort |
|
|
|
| Chinese-Global Cohort |
|
|
| Japanese-Global Cohort |
|
|
| Other-Global Cohort |
|
|
| Missing-Global Cohort |
|
|
| Hispanic or Latino-Global Cohort |
|
|
| Chinese-China cohort |
|
|
|
| Current smokers-Global Cohort |
|
|
| Former smokers-Global Cohort |
|
|
| Never smoked-China Cohort |
|
|
| Current smokers-China Cohort |
|
|
| Former smokers-China Cohort |
|
|
| Hazard Ratio (HR) |
| 0.56 |
| 2-Sided |
| 95 |
| 0.37 |
| 0.85 |
| Other |
The china cohort was not powered for superiority |
| OG002 |
| Osimertinib 80 mg (China Cohort) |
Randomized participants received Osimertinib 80 mg orally once daily (QD) |
| OG003 | SoC EGFR-TKI (China Cohort) | Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD. |
|
|
Randomized participants received Osimertinib 80 mg orally once daily (QD) |
| OG003 | SoC EGFR-TKI (China Cohort) | Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD. |
|
|
|
Randomized participants received Osimertinib 80 mg orally once daily (QD)
| OG003 | SoC EGFR-TKI (China Cohort) | Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD. |
|
|
|
Randomized participants received Osimertinib 80 mg orally once daily (QD) |
| OG003 | SoC EGFR-TKI (China Cohort) | Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD. |
|
|
|
Randomized participants received Osimertinib 80 mg orally once daily (QD) |
| OG003 | SoC EGFR-TKI (China Cohort) | Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD. |
|
|
|
Randomized participants received Osimertinib 80 mg orally once daily (QD)
| OG003 | SoC EGFR-TKI (China Cohort) | Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD. |
|
|
|
|
|
|
| OG002 | Osimertinib 80 mg (China Cohort) | Randomized participants received Osimertinib 80 mg orally once daily (QD) |
| OG003 | SoC EGFR-TKI (China Cohort) | Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD. |
|
|
Randomized participants received Osimertinib 80 mg orally once daily (QD)
| OG001 | SoC EGFR-TKI (Global Cohort) | Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD. |
| OG002 | Osimertinib 80 mg (China Cohort) | Randomized participants received Osimertinib 80 mg orally once daily (QD) |
| OG003 | SoC EGFR-TKI (China Cohort) | Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD. |
|
|
| OG001 | SoC EGFR-TKI (Global Cohort) | Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD. |
| OG002 | Osimertinib 80 mg (China Cohort) | Randomized participants received Osimertinib 80 mg orally once daily (QD) |
| OG003 | SoC EGFR-TKI (China Cohort) | Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD. |
|
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