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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004133-33 | EudraCT Number |
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This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally BID. Participants will receive treatment until disease progression, unacceptable toxicity, withdrawal of consent, or death. The study is expected to last approximately 144 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alectinib | Experimental | Participants will receive alectinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death. |
|
| Crizotinib | Active Comparator | Participants will receive crizotinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alectinib | Drug | Participants will receive alectinib 600 mg orally (four 150 mg capsules) BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) by Investigator Assessment | PFS was assessed as time to disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions. | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) |
| Percentage of Participants With PFS Event by Investigator Assessment | PFS was assessed percentage of participants with disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions. | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) |
| Measure | Description | Time Frame |
|---|---|---|
| PFS Independent Review Committee (IRC)-Assessed | PFS was assessed as time to disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Valley Hem Onc Med Grp | Northridge | California | 91325 | United States | ||
| TMPN/ Cancer Care Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39661917 | Derived | Sikkema BJ, Baart SJ, Paats MS, Smit EF, Schols AMWJ, Mathijssen RHJ, van Rossum EFC, Dingemans AC. Body Weight Gain Associated With Alectinib in Patients With ALK+ Non-Small Cell Lung Cancer: Pooled Analysis of Individual Patient Data From Four Prospective Clinical Trials. J Clin Oncol. 2025 Feb 20;43(6):641-650. doi: 10.1200/JCO-24-01579. Epub 2024 Dec 11. | |
| 35275991 |
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A total of 303 participants were randomized and included in the intent-to-treat (ITT) population; 152 participants in the alectinib arm and 151 participants in the crizotinib arm.
The study recruited treatment-naive participants with Anaplastic Lymphoma Kinase (ALK)-positive advanced Non-Small Cell Lung Cancer (NSCLC) in 29 countries from August 2014 to January 2016. The study achieved its protocol-defined definition of completion when the required number of death events was reached, at which point it could be terminated for all participants. The administrative study termination did not impact the overall study completion status.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alectinib | Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death. |
| FG001 | Crizotinib |
| 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 | Oct 15, 2023 | Apr 27, 2026 |
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| Crizotinib | Drug | Participants will receive crizotinib 250 mg capsules orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death. |
|
| Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) |
| Percentage of Participants With PFS Event by IRC | PFS was assessed as percentage of participants with disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions. | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) |
| Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using RECIST V1.1 Criteria | CNS progression was assessed as percentage of participants with an event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib. | Randomization to CNS PD as first occurrence of disease progression (assessed every 8 weeks up to 33 months) |
| Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using Revised Assessment in Neuro Oncology (RANO) Criteria | CNS progression was assessed as percentage of participants with event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib. | Randomization to the first occurrence of disease progression in the CNS (assessed every 8 weeks up to 33 months) |
| Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) as Determined by The Investigators According to RECIST V1.1 Criteria | ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) |
| Duration of Response (DOR) According to RECIST V1.1 Criteria as Assessed by the Investigators | DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR. | First occurrence of objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to approximately 10 years) |
| Overall Survival (OS) | Overall survival (OS) was defined as the time from randomization to death from any cause. | From randomization until death (up to 10.5 years) |
| Percentage of Participants With OS Event | Overall survival (OS) was defined as the time from randomization to death from any cause. | From randomization until death (up to 10.5 years) |
| Percentage of Participants With CNS ORR of CR or PR IRC-assessed According to RECIST v1.1 Criteria | CNS ORR was defined as the percentage of participants who attained CR or PR and had measurable/non-measurable CNS lesions at baseline. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) |
| CNS DOR IRC-assessed According to RECIST v1.1 Criteria | CNS DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR. | First occurrence of CNS objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) |
| Percentage of Participants With Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Baseline up to approximately 10 years |
| Area Under The Concentration-Time Curve (AUC) of Alectinib | Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months) |
| Maximum Concentration (Cmax) of Alectinib | Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) |
| Time to Reach Cmax (Tmax) of Alectinib | Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) |
| AUC of Alectinib Metabolite | Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months) |
| Cmax of Alectinib Metabolite | Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) |
| Tmax of Alectinib Metabolite | Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) |
| Time to Deterioration by European Organization for The Research And Treatment of Cancer (EORTC) Quality Of Life Questionnaire Core 30 (C30) | The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a >or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point decrease from baseline followed by death within 5 weeks from the last assessment. | Baseline, every 4 weeks until disease progression (up to 33 months) |
| Percentage of Participants With Deterioration by EORTC Quality Of Life Questionnaire Core 30 (C30) | The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a >or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point decrease from baseline followed by death within 5 weeks from the last assessment. | Baseline, every 4 weeks until disease progression (up to 33 months) |
| Time to Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13) | The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a >or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point increase above baseline followed by death within 5 weeks from the last assessment. | Baseline, every 4 weeks until disease progression (up to 33 months) |
| Percentage of Participants With Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13) | The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a >or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point increase above baseline followed by death within 5 weeks from the last assessment. | Baseline, every 4 weeks until disease progression (up to 33 months) |
| Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire C30 Score | The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. | Baseline, every 4 weeks until disease progression (up to 33 months) |
| HRQoL by EORTC Quality of Life Questionnaire LC13 Score Coughing | The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. | Baseline, every 4 weeks until disease progression (up to 33 months) |
| HRQoL by EORTC Quality of Life Questionnaire LC13 Score Dyspnoea | The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. | Baseline, every 4 weeks until disease progression (up to 33 months) |
| HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Chest | The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. | Baseline, every 4 weeks until disease progression (up to 33 months) |
| HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Arm and Shoulder | The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. | Baseline, every 4 weeks until disease progression (up to 33 months) |
| Redondo Beach |
| California |
| 90277 |
| United States |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States |
| University of Miami-Deerfield Beach | Deerfield Beach | Florida | 33442 | United States |
| Beth Israel Deaconess Med Ctr | Boston | Massachusetts | 02215 | United States |
| Dana Farber Can Ins | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Washington Uni School of Medicine | St Louis | Missouri | 63110 | United States |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | United States |
| University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Kinghorn Cancer Centre | Darlinghurst | New South Wales | 2010 | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| Calvary Mater Newcastle | Waratah | New South Wales | 2298 | Australia |
| Queen Elizabeth Hospital | Adelaide | South Australia | 5011 | Australia |
| Monash Health Translational Precinct | Victoria | Victoria | 3168 | Australia |
| University Clinical Center Sarajevo | Sarajevo | 71000 | Bosnia and Herzegovina |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Sunnybrook Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Centro Internacional de Estudios ClÃnicos (CIEC) | Santiago | 8420383 | Chile |
| Sun Yet-sen University Cancer Center | Guangzhou | 510060 | China |
| Shanghai Pulmonary Hospital | Shanghai | 200433 | China |
| Clinica CIMCA | San José | DUMMY_VALUE | Costa Rica |
| Kasr Eieny Uni Hospital | Cairo | 11555 | Egypt |
| Chu Grenoble - Hopital Albert Michallon | Grenoble | 38043 | France |
| CHRU de Lille | Lille | 59037 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Hopital Haut Leveque | Pessac | 33604 | France |
| Grupo Angeles | Guatemala City | 01015 | Guatemala |
| Tuen Mun Hospital | Hong Kong | 852 | Hong Kong |
| Pamela Youde Nethersole Eastern Hospital | Hong Kong | DUMMY_VALUE | Hong Kong |
| Princess Margaret Hospital | Hong Kong | DUMMY_VALUE | Hong Kong |
| Queen Mary Hospital | Hong Kong | DUMMY_VALUE | Hong Kong |
| Prince of Wales Hosp | Hong Kong | Hong Kong |
| Rambam Medical Center | Haifa | 4959381 | Israel |
| Meir Medical Center | Kfar Saba | 44281 | Israel |
| Irccs Ist. Tumori Giovanni Paolo Ii | Bari | Apulia | 70124 | Italy |
| A.O. Universitaria Di Parma | Parma | Emilia-Romagna | 43100 | Italy |
| Ospedale Provinciale Santa Maria Delle Croci | Ravenna | Emilia-Romagna | 48100 | Italy |
| Policlinico Umberto i di Roma | Rome | Lazio | 00161 | Italy |
| Irccs Istituto Nazionale Dei Tumori (Int) | Milan | Lombardy | 20133 | Italy |
| Irccs Istituto Europeo Di Oncologia (IEO) | Milan | Lombardy | 20141 | Italy |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga | Orbassano | Piedmont | 10043 | Italy |
| Az Ospedaliera Nuovo Garibaldi Quartiere Nesima | Catania | Sicily | 95122 | Italy |
| Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia | Perugia | Umbria | 06156 | Italy |
| Instituto Nacional De Enfermedades Respiratorias | Mexico City | Mexico CITY (federal District) | 14080 | Mexico |
| Uni of Auckland | Auckland | DUMMY_VALUE | New Zealand |
| Uniwersyteckie Centrum Kliniczne | Gda?sk | 80-214 | Poland |
| Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej | Lublin | 20-064 | Poland |
| Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie | Olsztyn | 10-357 | Poland |
| Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie | Warsaw | 02-781 | Poland |
| CHUC - Unidade de Pneumologia Oncológica | Coimbra | 3000-075 | Portugal |
| IPO de Lisboa | Lisbon | 1099-023 | Portugal |
| IPO do Porto | Porto | 4200-072 | Portugal |
| Moscow City Oncology Hospital #62 | Moscovskaya Oblast | Moscow Oblast | 143423 | Russia |
| SPb City Clin Onc Dsp | Saint Petersburg | Sankt-Peterburg | 197022 | Russia |
| Scientific Research Oncology Institute named after N.N. Petrov | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| N.N.Burdenko Main Military Clinical Hospital | Moscow | 105229 | Russia |
| Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| Institute for pulmonary diseases of Vojvodina | Kamenitz | 21204 | Serbia |
| National University Hospital | Singapore | 119228 | Singapore |
| National Cancer Centre | Singapore | 169610 | Singapore |
| National Cancer Center | Gyeonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital General Univ. de Alicante | Alicante | 3010 | Spain |
| Vall d'Hebron Institute of Oncology (VHIO), Barcelona | Barcelona | 08035 | Spain |
| Hospital Universitari Germans Trias i Pujol | Barcelona | 08916 | Spain |
| Hospital Universitario Puerta de Hierro | Madrid | 28222 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Universitaetsspital Basel | Basel | 4031 | Switzerland |
| Inselspital Bern | Bern | 3010 | Switzerland |
| CHUV | Lausanne | 1011 | Switzerland |
| UniversitätsSpital Zürich | Zurich | 8091 | Switzerland |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Cheng Kung Univ Hosp | Tainan | 00704 | Taiwan |
| National Taiwan University Hospital | Taipei | 00100 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 00112 | Taiwan |
| National Cancer Inst. | Bangkok | 10400 | Thailand |
| Chiang Rai Prachanukroh Hospital | Chiang Rai | 57000 | Thailand |
| Khonkaen Hospital | Khonkaen | 40000 | Thailand |
| King Chulalongkorn Memorial Hospital | Patumwan | 10330 | Thailand |
| Songklanagarind Hospital | Songkhla | 90110 | Thailand |
| Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital | Adana | 01250 | Turkey (Türkiye) |
| Ankara University Medical Faculty | Ankara | 06100 | Turkey (Türkiye) |
| Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department | Edirne | 22770 | Turkey (Türkiye) |
| Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department | Malatya | 44280 | Turkey (Türkiye) |
| Kyiv Regional Oncological Dispensary | Kyiv | 04107 | Ukraine |
| Lviv State Oncology Regional Treatment and Diagnostic Centre | Lviv | 79031 | Ukraine |
| Birmingham Heartlands Hospital | Birmingham | B9 5SS | United Kingdom |
| University College London Hospital | London | NW1 - 2PG | United Kingdom |
| Guys & St Thomas Hospital | London | SE1 9RT | United Kingdom |
| Dziadziuszko R, Peters S, Mok T, Camidge DR, Gadgeel SM, Ou SI, Konopa K, Noe J, Nowicka M, Bordogna W, Morcos PN, Smoljanovic V, Shaw AT. Circulating Cell-free DNA as a Prognostic Biomarker in Patients with Advanced ALK+ Non-small Cell Lung Cancer in the Global Phase III ALEX Trial. Clin Cancer Res. 2022 May 2;28(9):1800-1808. doi: 10.1158/1078-0432.CCR-21-2840. |
| 32418886 | Derived | Mok T, Camidge DR, Gadgeel SM, Rosell R, Dziadziuszko R, Kim DW, Perol M, Ou SI, Ahn JS, Shaw AT, Bordogna W, Smoljanovic V, Hilton M, Ruf T, Noe J, Peters S. Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study. Ann Oncol. 2020 Aug;31(8):1056-1064. doi: 10.1016/j.annonc.2020.04.478. Epub 2020 May 11. |
| 30215676 | Derived | Gadgeel S, Peters S, Mok T, Shaw AT, Kim DW, Ou SI, Perol M, Wrona A, Novello S, Rosell R, Zeaiter A, Liu T, Nuesch E, Balas B, Camidge DR. Alectinib versus crizotinib in treatment-naive anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer: CNS efficacy results from the ALEX study. Ann Oncol. 2018 Nov 1;29(11):2214-2222. doi: 10.1093/annonc/mdy405. |
| 29656744 | Derived | Burudpakdee C, Wong W, Seetasith A, Corvino FA, Yeh W, Gubens M. Economic impact of preventing brain metastases with alectinib in ALK-positive non-small cell lung cancer. Lung Cancer. 2018 May;119:103-111. doi: 10.1016/j.lungcan.2018.03.008. Epub 2018 Mar 9. |
| 28586279 | Derived | Peters S, Camidge DR, Shaw AT, Gadgeel S, Ahn JS, Kim DW, Ou SI, Perol M, Dziadziuszko R, Rosell R, Zeaiter A, Mitry E, Golding S, Balas B, Noe J, Morcos PN, Mok T; ALEX Trial Investigators. Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Aug 31;377(9):829-838. doi: 10.1056/NEJMoa1704795. Epub 2017 Jun 6. |
| 28501139 | Derived | Gainor JF, Shaw AT. J-ALEX: alectinib versus crizotinib in ALK-positive lung cancer. Lancet. 2017 Jul 1;390(10089):3-4. doi: 10.1016/S0140-6736(17)31074-7. Epub 2017 May 10. No abstract available. |
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on intent to treat (ITT) population which included all randomized participants in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Alectinib | Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death. |
| BG001 | Crizotinib | Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death. |
| BG002 | Total | Total of all reporting groups |
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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 | Progression-Free Survival (PFS) by Investigator Assessment | PFS was assessed as time to disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions. | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) |
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| Primary | Percentage of Participants With PFS Event by Investigator Assessment | PFS was assessed percentage of participants with disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions. | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Posted | Number | Percentage of Participants | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) |
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| Secondary | PFS Independent Review Committee (IRC)-Assessed | PFS was assessed as time to disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions. | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) |
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| Secondary | Percentage of Participants With PFS Event by IRC | PFS was assessed as percentage of participants with disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions. | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Posted | Number | Percentage of Participants | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) |
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| Secondary | Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using RECIST V1.1 Criteria | CNS progression was assessed as percentage of participants with an event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib. | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Posted | Number | Percentage of Participants | Randomization to CNS PD as first occurrence of disease progression (assessed every 8 weeks up to 33 months) |
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| Secondary | Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using Revised Assessment in Neuro Oncology (RANO) Criteria | CNS progression was assessed as percentage of participants with event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib. | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Posted | Number | Percentage of Participants | Randomization to the first occurrence of disease progression in the CNS (assessed every 8 weeks up to 33 months) |
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| Secondary | Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) as Determined by The Investigators According to RECIST V1.1 Criteria | ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) |
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| Secondary | Duration of Response (DOR) According to RECIST V1.1 Criteria as Assessed by the Investigators | DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR. | ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants with a BOR of CR or PR. | Posted | Median | 95% Confidence Interval | Months | First occurrence of objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to approximately 10 years) |
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| Secondary | Overall Survival (OS) | Overall survival (OS) was defined as the time from randomization to death from any cause. | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From randomization until death (up to 10.5 years) |
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| Secondary | Percentage of Participants With OS Event | Overall survival (OS) was defined as the time from randomization to death from any cause. | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Posted | Number | Percentage of Participants | From randomization until death (up to 10.5 years) |
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| Secondary | Percentage of Participants With CNS ORR of CR or PR IRC-assessed According to RECIST v1.1 Criteria | CNS ORR was defined as the percentage of participants who attained CR or PR and had measurable/non-measurable CNS lesions at baseline. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure (number of participants with measurable/non-measurable CNS lesions at baseline). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) |
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| Secondary | CNS DOR IRC-assessed According to RECIST v1.1 Criteria | CNS DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR. | ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants with a BOR of CR or PR. | Posted | Median | 95% Confidence Interval | months | First occurrence of CNS objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) |
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| Secondary | Percentage of Participants With Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Safety (SAF) population included all participants who received at least one dose of any study drug. | Posted | Number | Percentage of Participants | Baseline up to approximately 10 years |
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| Secondary | Area Under The Concentration-Time Curve (AUC) of Alectinib | The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months) |
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| Secondary | Maximum Concentration (Cmax) of Alectinib | The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL) | Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) |
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| Secondary | Time to Reach Cmax (Tmax) of Alectinib | The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. | Posted | Median | Full Range | hours | Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) |
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| Secondary | AUC of Alectinib Metabolite | The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months) |
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| Secondary | Cmax of Alectinib Metabolite | The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL) | Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) |
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| Secondary | Tmax of Alectinib Metabolite | The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. | Posted | Median | Full Range | hours | Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) |
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| Secondary | Time to Deterioration by European Organization for The Research And Treatment of Cancer (EORTC) Quality Of Life Questionnaire Core 30 (C30) | The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a >or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point decrease from baseline followed by death within 5 weeks from the last assessment. | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Baseline, every 4 weeks until disease progression (up to 33 months) |
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| Secondary | Percentage of Participants With Deterioration by EORTC Quality Of Life Questionnaire Core 30 (C30) | The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a >or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point decrease from baseline followed by death within 5 weeks from the last assessment. | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Posted | Number | Percentage of Participants | Baseline, every 4 weeks until disease progression (up to 33 months) |
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| Secondary | Time to Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13) | The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a >or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point increase above baseline followed by death within 5 weeks from the last assessment. | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Baseline, every 4 weeks until disease progression (up to 33 months) |
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| Secondary | Percentage of Participants With Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13) | The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a >or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point increase above baseline followed by death within 5 weeks from the last assessment. | ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure. | Posted | Number | Percentage of Participants | Baseline, every 4 weeks until disease progression (up to 33 months) |
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| Secondary | Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire C30 Score | The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. | ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points. | Posted | Median | Full Range | Score on a scale | Baseline, every 4 weeks until disease progression (up to 33 months) |
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| Secondary | HRQoL by EORTC Quality of Life Questionnaire LC13 Score Coughing | The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. | ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points. | Posted | Median | Full Range | Score on a scale | Baseline, every 4 weeks until disease progression (up to 33 months) |
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| Secondary | HRQoL by EORTC Quality of Life Questionnaire LC13 Score Dyspnoea | The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. | ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points. | Posted | Median | Full Range | Score on a scale | Baseline, every 4 weeks until disease progression (up to 33 months) |
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| Secondary | HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Chest | The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. | ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points. | Posted | Median | Full Range | Score on a scale | Baseline, every 4 weeks until disease progression (up to 33 months) |
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| Secondary | HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Arm and Shoulder | The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. | ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points. | Posted | Median | Full Range | Score on a scale | Baseline, every 4 weeks until disease progression (up to 33 months) |
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Baseline up to approximately 10 years
Not provided
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 | Alectinib | Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death. | 76 | 152 | 70 | 152 | 138 | 152 |
| EG001 | Crizotinib | Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death. | 73 | 151 | 48 | 151 | 143 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Aphasia | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Hemiparesis | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Lymphoedema | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Hepatotoxicity | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Disorientation | Psychiatric disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Cardiac tamponade | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Death | General disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Hyperthermia malignant | General disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Oedema | General disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Sudden death | General disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Drug-induced liver injury | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Acinetobacter infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Enteritis infectious | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Hepatitis viral | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Necrotising fasciitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Oesophageal candidiasis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Human chorionic gonadotropin increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Intracranial tumour haemorrhage | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Neurological decompensation | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Bronchopleural fistula | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2017 | Apr 27, 2026 | SAP_003.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582670 | alectinib |
| D000077547 | Crizotinib |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
| D011725 | Pyridines |
Not provided
Not provided
| Male |
|
| Ethinicity - Not Hispanic or Latino |
|
| Ethnicity - Not Stated |
|
| Race - Asian |
|
| Race - Black or African American |
|
| Race - Native Hawaiian or other Pacific Islander |
|
| Race - White |
|
| Race - Unknown |
|
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