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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003605-42 | EudraCT Number |
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This is a randomized, Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in two phases: Induction Phase and Maintenance Phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed | Experimental | Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period. |
|
| Arm B (Carboplatin or Cisplatin + Pemetrexed) | Active Comparator | Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Participants received IV infusion of 1200 mg atezolizumab on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurred first. | Randomization up to approximately 39 months |
| Overall Survival (OS) | OS is defined as time from randomization to death from any cause. | Randomization up to approximately 39 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Rate at Year 1 | The Overall Survival Rate at the 1-year landmark time point is defined as the probabilities that participants are alive 1-year after randomization. | Year 1 |
| Overall Survival Rate Year 2 |
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Inclusion Criteria:
Exclusion Criteria:
Cancer-Specific Exclusions
General Medical Exclusions:
Exclusion Criteria Related to Medications and Chemotherapy:
Exclusion Criteria Related to Chemotherapy:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles Hematology Oncology Medical Group | Los Angeles | California | 90017 | United States | ||
| St. Joseph Heritage Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36795388 | Derived | Socinski MA, Jotte RM, Cappuzzo F, Nishio M, Mok TSK, Reck M, Finley GG, Kaul MD, Yu W, Paranthaman N, Bara I, West HJ. Association of Immune-Related Adverse Events With Efficacy of Atezolizumab in Patients With Non-Small Cell Lung Cancer: Pooled Analyses of the Phase 3 IMpower130, IMpower132, and IMpower150 Randomized Clinical Trials. JAMA Oncol. 2023 Apr 1;9(4):527-535. doi: 10.1001/jamaoncol.2022.7711. | |
| 36052772 |
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The study is considered "Completed" because the planned study activities and analyses have been performed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm B (Carboplatin or Cisplatin + Pemetrexed) | Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period. |
| 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 | Feb 11, 2020 | Nov 3, 2023 |
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|
| Carboplatin | Drug | Participants received IV infusion of carboplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period with doses calculated using Calvart formula. |
|
| Cisplatin | Drug | Participants received IV infusion of 75 mg/m^2 cisplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period. |
|
| Pemetrexed | Drug | Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period. |
|
The Overall Survival Rate at the 2-year landmark time point is defined as the probabilities that participants are alive 2-years after randomization.
| Year 2 |
| Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) Assessed by the Investigator Using RECIST V1.1 | An objective response is defined as either an unconfirmed CR or a PR, as determined by the investigator using RECIST v1.1. Objective Response Rate is defined as the proportion of patients who had an objective response. | Randomization up to approximately 25 months |
| Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 | DOR is defined as the time interval from the date of the first occurrence of a CR or PR (whichever status is recorded first) until the first date that progressive disease or death is documented, whichever occurs first. | Randomization up to approximately 25 months |
| Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score | EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998). | Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months) |
| Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score | The EORTC QLQ-LC13 module incorporates one multiple item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998). | Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months) |
| Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score | Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms & are scored at individual symptom level, thus have a dyspnea score, chest pain score, & cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 & maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 & 2, 'Cough' score is mean of question 3 & 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea & cough symptom scores is considered to be clinically significant; whereas a score change of≥0.5 points for chest pain score is considered to be clinically significant. | Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months) |
| Minimum Observed Serum Atezolizumab Concentration (Cmin) | Minimum observed serum atezolizumab concentration (Cmin) prior to infusion at selected cycles (Arm A) | Predose (Prd; 0 hour [h]) on D1 of Cy 2,3,4,8,16 (Cy length=21 days) and thereafter on D1 of every 8th cycle (up to approximately 25 months) |
| Maximum Observed Serum Atezolizumab Concentration (Cmax) | Maximum observed serum atezolizumab concentration (Cmax) after infusion (Arm A) | Day 1 of Cycle 1 (Cycle length=21 days) |
| Plasma Concentrations for Carboplatin in Arm A(Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) | Prd (0 h), 5-10 minutes (mins) before end of carboplatin infusion (infusion duration=1-2 h), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days) |
| Plasma Concentrations for Cisplatin in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) | Prd (0 h), 5-10 mins before end of cisplatin infusion (infusion duration=30-60 mins), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days) |
| Plasma Concentrations for Pemetrexed in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) | Prd (0 h), 5-10 mins before end of pemetrexed infusion (infusion duration=10 mins), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days) |
| Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) of Atezolizumab | Baseline prevalence and post-baseline incidence of anti-drug antibodies (ADA) to Atezolizumab in the Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) | Prd (0 h) on D1 of Cy1,2,3,4,8,16 (Cy length=21 days) and thereafter on D1 of every 8th cycle, at treatment discontinuation & then every 30 days (up to 120 days) after last dose of atezolizumab (up to app 25 months) |
| Sebastopol |
| California |
| 95472 |
| United States |
| Stamford Hospital; BCC, MOHR | Stamford | Connecticut | 06904 | United States |
| Orlando Health Inc. | Orlando | Florida | 32806 | United States |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Illinois Cancer Care | Peoria | Illinois | 61615 | United States |
| HealthCare Research Network II, LLC - PPDS | Tinley Park | Illinois | 60487 | United States |
| Fort Wayne Med Oncology & Hematology Inc | Fort Wayne | Indiana | 46845 | United States |
| Goshen Health System | Goshen | Indiana | 46526 | United States |
| University of Kentucky; Markey Cancer Center | Lexington | Kentucky | 40536 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109-0934 | United States |
| CHI Health St. Francis | Grand Island | Nebraska | 68803 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Swedish Cancer Institute | Cary | North Carolina | 27513 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Gettysburg Cancer Center | Gettysburg | Pennsylvania | 17325 | United States |
| Allegheny Cancer Center | Pittsburgh | Pennsylvania | 15212 | United States |
| Oncology Consultants PA | Houston | Texas | 77030 | United States |
| Virginia Cancer Specialists (Fairfax) - USOR | Fairfax | Virginia | 22031 | United States |
| Peninsula Cancer Institute | Newport News | Virginia | 23601 | United States |
| Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| St. Vincent Hospital | Green Bay | Wisconsin | 54311 | United States |
| Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich | Buenos Aires | 00001428 | Argentina |
| Fundacion Clinica Colombo | Córdoba | X5002AOQ | Argentina |
| Clinica Viedma S.A. | Viedma | R8500ACE | Argentina |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| Sydney Adventist Hospital; Clinical Trial Unit | Sydney | New South Wales | 2076 | Australia |
| St George Hospital; Medical Oncology | Sydney | New South Wales | 2217 | Australia |
| Redcliffe Hospital | Redcliffe | Queensland | 4020 | Australia |
| Mater Adult Hospital | South Brisbane | Queensland | 4101 | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | 7000 | Australia |
| Ballarat Health Services | Ballarat | Victoria | 3350 | Australia |
| Peninsula and South Eastern Haematology and Oncology Group | Frankston | Victoria | 3199 | Australia |
| Barwon Health | Geelong | Victoria | 3220 | Australia |
| Klinikum Wels-Grieskirchen GmbH | Wels | 4600 | Austria |
| AZ Maria Middelares | Ghent | 9000 | Belgium |
| Clinique André Renard; Pneumologie | Herstal | 4040 | Belgium |
| AZ Delta (Campus Rumbeke), Apotheek | Roeselare | 8800 | Belgium |
| Multiprofile Hospital for Active Treatment Serdika EOOD | Sofia | 1303 | Bulgaria |
| Health & Care SPA | Santiago | 7500006 | Chile |
| Sociedad de Investigaciones Medicas Ltda (SIM) | Temuco | 4800827 | Chile |
| Hospital Clinico Vina del Mar? | Viña del Mar | 2520612 | Chile |
| Beijing Friendship Hospital Affiliated of Capital University of Medical Science | Beijing | 100050 | China |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| Hunan Cancer Hospital | Changsha | 410013 | China |
| Changzhou First People's Hospital | Changzhou | 213003 | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | 510120 | China |
| The First Affiliated Hospital of Medical School of Zhejiang University | Hangzhou | 310003 | China |
| Sir Run Run Shaw Hospital Zhejiang University | Hangzhou | 310016 | China |
| Anhui Provincial Hospital; 2F,Tumor chemotherapy Department | Hefei | 230001 | China |
| Anhui Provincial Hospital; Respiratory Department | Hefei | 230088 | China |
| Qilu Hospital | Jinan | 250012 | China |
| Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) | Nanjing | 210029 | China |
| Shanghai Chest Hospital | Shanghai | 200000 | China |
| Zhongshan Hospital Fudan University | Shanghai | 200032 | China |
| First Hospital of China Medical University | Shenyang | 110001 | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | 3000060 | China |
| Tianjin Medical University General Hospital | Tianjin | 300052 | China |
| Tumor Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | 430023 | China |
| Tongji Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | 430030 | China |
| Zhejiang Cancer Hospital | Zhejiang | 310022 | China |
| Institut Sainte Catherine | Avignon | 84082 | France |
| Hopital Louis Pradel; Pneumologie | Bron | 69677 | France |
| Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne | Clermont-Ferrand | 63003 | France |
| Centre Hospitalier Intercommunal; Service de Pneumologie | Créteil | 94010 | France |
| Polyclinique de Limoges - Site Chenieux; Oncologie Medicale | Limoges | 87039 | France |
| Hopital Nord AP-HM | Marseille | 13015 | France |
| Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie | Montpellier | 34298 | France |
| Centre Hospitalier de Mulhouse - Hopital Emile Muller | Mulhouse | 68070 | France |
| Hopital d'Instruction des Armees de Begin | Saint-Mandé | 94160 | France |
| Hopital d Instruction des Armees de Sainte Anne | Toulon | 83041 | France |
| Veszprem Megyei Tudogyogyintezet | Farkasgyepű | 8582 | Hungary |
| Petz Aladar Megyei Oktato Korhaz | Győr | 9024 | Hungary |
| Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Székesfehérvár | 8000 | Hungary |
| Markusovszky Hospital | Szombathely | 9700 | Hungary |
| Tudogyogyintezet Torokbalint | Törökbálint | 2045 | Hungary |
| Mater Misecordiae University Hospital | Dublin | 7 | Ireland |
| St James's Hospital | Dublin | 8 | Ireland |
| Barzilai Medical Center | Ashkelon | 7830604 | Israel |
| Edith Wolfson Medical Center | Holon | 5822012 | Israel |
| Rabin Medical Center | Petach Tiqwa | 4941492 | Israel |
| Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica | Lecce | Apulia | 73044 | Italy |
| Ospedale Casa Sollievo Della Sofferenza IRCCS | San Giovanni Rotondo | Apulia | 71013 | Italy |
| Azienda Ospedaliero Universitaria di Parma | Parma | Emilia-Romagna | 43126 | Italy |
| Ospedale Santa Maria Delle Croci | Ravenna | Emilia-Romagna | 48100 | Italy |
| Istituto Nazionale Tumori Regina Elena | Rome | Lazio | 00144 | Italy |
| Azienda Policlinico Umberto I | Rome | Lazio | 00161 | Italy |
| Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia Toracica | Orbassano (TO) | Piedmont | 10043 | Italy |
| Ospedale San Vincenzo Taormina :Divisione di Oncologia Medica | Taormina | Sicily | 98039 | Italy |
| Ospedale San Luca - USL2 Lucca | Lucca | Tuscany | 55100 | Italy |
| National Hospital Organization Nagoya Medical Center | Aichi | 460-0001 | Japan |
| National Cancer Center Hospital East | Chiba | 277-8577 | Japan |
| Hiroshima University Hospital | Hiroshima | 734-8551 | Japan |
| National Hospital Organization Asahikawa Medical Center | Hokkaido | 070-8644 | Japan |
| National Hospital Organization Himeji Medical Center | Hyōgo | 670-8520 | Japan |
| Kanazawa University Hospital | Ishikawa | 920-8641 | Japan |
| Kagoshima University Hospital | Kagoshima | 890-8520 | Japan |
| Kanagawa Cancer Center | Kanagawa | 241-8515 | Japan |
| Tohoku University Hospital | Miyagi | 980-8574 | Japan |
| Niigata University Medical & Dental Hospital | Niigata | 951-8520 | Japan |
| Osaka University Hospital | Osaka | 565-0871 | Japan |
| Osaka Medical and Pharmaceutical University Hospital | Osaka | 569-8686 | Japan |
| Saga University Hospital | Saga | 849-8501 | Japan |
| Tokushima University Hospital | Tokushima | 770-8503 | Japan |
| Juntendo University Hospital | Tokyo | 113-8431 | Japan |
| Nippon Medical School Hospital | Tokyo | 113-8603 | Japan |
| Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital | Tokyo | 113-8677 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135-8550 | Japan |
| NTT Medical Center Tokyo | Tokyo | 141-8625 | Japan |
| National Hospital Organization Yamaguchi - Ube Medical Center | Yamaguchi | 755-0241 | Japan |
| Riga East Clinical University Hospital Latvian Oncology Centre | Riga | LV-1079 | Latvia |
| Panevezys Hospital | Panevezys | 35144 | Lithuania |
| Hospital Kuala Lumpur | Kuala Lumpur | FED. Territory of Kuala Lumpur | 50586 | Malaysia |
| Advanced Medical and Dental Institute; Kompleks Klinikal | Kepala Batas | Pulau Pinang | 13200 | Malaysia |
| Amphia Ziekenhuis | Breda | 4819 EV | Netherlands |
| Ziekenhuis Gelderse Vallei | Ede | 6716 RP | Netherlands |
| Ziekenhuis St. Jansdal | Harderwijk | 3844 DG | Netherlands |
| Zuyderland Medisch Centrum - Sittard Geleen | Sittard-Geleen | 6162 BG | Netherlands |
| Haga Ziekenhuis | The Hague | 2547 EX | Netherlands |
| ETZ TweeSteden | Tilburg | 5042AD | Netherlands |
| Hospital Nacional Cayetano Heredia | Lima | 31 | Peru |
| Hospital Beatriz Angelo | Loures | 2674-514 | Portugal |
| Unidade Local de Saude de Matosinhos SA | Matosinhos Municipality | 4454-509 | Portugal |
| Hospital CUF Porto; Servico de Imunoalergologia | Senhora Da Hora - Porto | 4460-188 | Portugal |
| Medisprof SRL | Cluj-Napoca | 400058 | Romania |
| Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta | Constanța | 900591 | Romania |
| Euroclinic Center of Oncology SRL | Iași | 700106 | Romania |
| Chelyabinsk Regional Clinical Oncology Dispensary | Chelyabinsk | Moscow Oblast | 454087 | Russia |
| Moscow City Oncology Hospital #62 | Moscovskaya Oblast | Moscow Oblast | 143423 | Russia |
| Regional Clinical Oncology Hospital | Yaroslavl | 150040 | Russia |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital General Universitario de Elche; Servicio de Oncologia | Elche | Alicante | 03203 | Spain |
| Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| ICO L'Hospitalet; Servicio de oncologia medica | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Corporacio Sanitaria Parc Tauli; Servicio de Oncologia | Sabadell | Barcelona | 8208 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Sant Andreu de la Barca | Barcelona | 08740 | Spain |
| Hospital de Mataro | Mataro | Cantabria | 08304 | Spain |
| Onkologikoa; Ensayos Clinicos | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Centro Oncologico de Galicia COG; Medical Oncology | A Coruña | LA Coruña | 15009 | Spain |
| Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia | El Palmar | Murcia | 30120 | Spain |
| Clinica Universitaria de Navarra; Servicio de Oncologia | Pamplona | Navarre | 31008 | Spain |
| Complejo Hospitalario de Navarra; Servicio de Oncologia | Pamplona | Navarre | 31008 | Spain |
| Complejo Hospitalario Nuestra Senora de Valme | Seville | Sevilla | 41014 | Spain |
| Hospital General Univ. de Alicante | Alicante | 03010 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica | Barcelona | 08028 | Spain |
| C.A.U de Burgos- Hospital Universitario de Burgos; Servicio de Oncologia | Burgos | 09006 | Spain |
| Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica | Girona | 17007 | Spain |
| Hospital Lucus Augusti; Servicio de Oncologia | Lugo | 27003 | Spain |
| MD Anderson Cancer Center | Madrid | 28033 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| HM Sanchinarro ? CIOCC | Madrid | 28050 | Spain |
| Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia | Málaga | 29010 | Spain |
| Instituto Valenciano Oncologia; Oncologia Medica | Valencia | 46009 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Buddhist Dalin Tzuchi General Hospital | Dalin, Chiayi | 622 | Taiwan |
| E-DA Hospital; Chest | Kaohsiung City | 824 | Taiwan |
| Chi Mei Medical Center Liou Ying Campus | Liuying Township | 736 | Taiwan |
| National Taiwan Uni Hospital; Internal Medicine | Taipei | 100 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| Tri-Service General Hospital | Taipei | 11490 | Taiwan |
| MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council | Dnipropetrovsk | Katerynoslav Governorate | 49102 | Ukraine |
| Kyiv Railway Clinical Hospital #3 of Branch Health Center of PJSC Ukrainian Railway; Surgery Dept | Kyiv | Kharkiv Governorate | 02096 | Ukraine |
| MICR Oncology Dispensary of Cherkasy Regional Council; Regional Center of Clinical Oncology | Cherkasy | 18009 | Ukraine |
| Private Enterprise Private Manufacturing Company Acinus | Kirovograd | 25006 | Ukraine |
| Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Oncothoracic department | Sumy | 40022 | Ukraine |
| MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology | Zaporizhzhya | 69040 | Ukraine |
| Bristol Haematology and Oncology centre | Bristol | BS2 8ED | United Kingdom |
| Velindre Hospital | Cardiff | CF14 2TL | United Kingdom |
| Gartnavel General Hospital; Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| Raigmore Hospital | Inverness | IV2 3UV | United Kingdom |
| St George?s Hospital | London | SW17 ORE | United Kingdom |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| Churchill Hospital | Oxford | OX3 7LJ | United Kingdom |
| Derriford Hospital; Plymouth Oncology Centre | Plymouth | PL6 8DH | United Kingdom |
| Queen's Hospital | Romford | RM7 0AG | United Kingdom |
| Royal Cornwall Hospital | Truro | TR1 3LQ | United Kingdom |
| Derived |
| Lu S, Fang J, Wang Z, Fan Y, Liu Y, He J, Zhou J, Hu J, Xia J, Liu W, Shi J, Yi J, Cao L. Results from the IMpower132 China cohort: Atezolizumab plus platinum-based chemotherapy in advanced non-small cell lung cancer. Cancer Med. 2023 Feb;12(3):2666-2676. doi: 10.1002/cam4.5144. Epub 2022 Sep 2. |
| 35511917 | Derived | Ton TGN, Pal N, Trinh H, Mahrus S, Bretscher MT, Machado RJM, Sadetsky N, Chaudhary N, Lu MW, Riely GJ. Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data. Clin Cancer Res. 2022 Jul 1;28(13):2844-2853. doi: 10.1158/1078-0432.CCR-22-0471. |
| FG001 | Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed | Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm B (Carboplatin or Cisplatin + Pemetrexed) | Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase will begin maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period. |
| BG001 | Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed | Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurred first. | The ITT population was defined as all randomized patients, whether or not the patients received the assigned treatment. | Posted | Median | 95% Confidence Interval | Months | Randomization up to approximately 39 months |
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| Primary | Overall Survival (OS) | OS is defined as time from randomization to death from any cause. | The ITT population was defined as all randomized patients, whether or not the patients received the assigned treatment. | Posted | Median | 95% Confidence Interval | Months | Randomization up to approximately 39 months |
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| Secondary | Overall Survival Rate at Year 1 | The Overall Survival Rate at the 1-year landmark time point is defined as the probabilities that participants are alive 1-year after randomization. | The ITT population was defined as all randomized patients, whether or not the patients received the assigned treatment. | Posted | Number | 95% Confidence Interval | Percentage | Year 1 |
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| Secondary | Overall Survival Rate Year 2 | The Overall Survival Rate at the 2-year landmark time point is defined as the probabilities that participants are alive 2-years after randomization. | Posted | Number | 95% Confidence Interval | Percentage | Year 2 |
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| Secondary | Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) Assessed by the Investigator Using RECIST V1.1 | An objective response is defined as either an unconfirmed CR or a PR, as determined by the investigator using RECIST v1.1. Objective Response Rate is defined as the proportion of patients who had an objective response. | The ITT population was defined as all randomized patients, whether or not the patients received the assigned treatment. | Posted | Number | Percentage of Participants | Randomization up to approximately 25 months |
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| Secondary | Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 | DOR is defined as the time interval from the date of the first occurrence of a CR or PR (whichever status is recorded first) until the first date that progressive disease or death is documented, whichever occurs first. | DOR was assessed in participants who had an objective response as determined by the investigator using RECIST v1.1. | Posted | Number | 95% Confidence Interval | Months | Randomization up to approximately 25 months |
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| Secondary | Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score | EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998). | ITT population with a non-missing baseline and at least a post-baseline PRO assessment (i.e., PRO evaluable population). | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months) |
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| Secondary | Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score | The EORTC QLQ-LC13 module incorporates one multiple item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998). | ITT population with a non-missing baseline and at least a post-baseline PRO assessment (i.e., PRO evaluable population). | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months) |
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| Secondary | Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score | Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms & are scored at individual symptom level, thus have a dyspnea score, chest pain score, & cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 & maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 & 2, 'Cough' score is mean of question 3 & 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea & cough symptom scores is considered to be clinically significant; whereas a score change of≥0.5 points for chest pain score is considered to be clinically significant. | ITT population with a non-missing baseline and at least a post-baseline PRO assessment (i.e., PRO evaluable population). | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months) |
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| Secondary | Minimum Observed Serum Atezolizumab Concentration (Cmin) | Minimum observed serum atezolizumab concentration (Cmin) prior to infusion at selected cycles (Arm A) | PK analyses were based on PK observations from all patients who received atezolizumab, carboplatin, cisplatin or pemetrexed treatment and who provided at least one evaluable PK sample. | Posted | Mean | Standard Deviation | μg/mL | Predose (Prd; 0 hour [h]) on D1 of Cy 2,3,4,8,16 (Cy length=21 days) and thereafter on D1 of every 8th cycle (up to approximately 25 months) |
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| Secondary | Maximum Observed Serum Atezolizumab Concentration (Cmax) | Maximum observed serum atezolizumab concentration (Cmax) after infusion (Arm A) | PK analyses were based on PK observations from all patients who received atezolizumab, carboplatin, cisplatin or pemetrexed treatment and who provided at least one evaluable PK sample. | Posted | Mean | Standard Deviation | μg/mL | Day 1 of Cycle 1 (Cycle length=21 days) |
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| Secondary | Plasma Concentrations for Carboplatin in Arm A(Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) | PK analyses were based on PK observations from all patients who received atezolizumab, carboplatin, cisplatin or pemetrexed treatment and who provided at least one evaluable PK sample. | Posted | Mean | Standard Deviation | ng/mL | Prd (0 h), 5-10 minutes (mins) before end of carboplatin infusion (infusion duration=1-2 h), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days) |
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| Secondary | Plasma Concentrations for Cisplatin in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) | PK analyses were based on PK observations from all patients who received atezolizumab, carboplatin, cisplatin or pemetrexed treatment and who provided at least one evaluable PK sample. | Posted | Mean | Standard Deviation | ng/mL | Prd (0 h), 5-10 mins before end of cisplatin infusion (infusion duration=30-60 mins), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days) |
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| Secondary | Plasma Concentrations for Pemetrexed in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) | PK analyses were based on PK observations from all patients who received atezolizumab, carboplatin, cisplatin or pemetrexed treatment and who provided at least one evaluable PK sample. | Posted | Mean | Standard Deviation | ng/mL | Prd (0 h), 5-10 mins before end of pemetrexed infusion (infusion duration=10 mins), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days) |
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| Secondary | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) of Atezolizumab | Baseline prevalence and post-baseline incidence of anti-drug antibodies (ADA) to Atezolizumab in the Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) | The ADA evaluable population was defined as patients with a non-missing baseline ADA sample and >=1 non-missing post-baseline ADA sample. | Posted | Number | Percentage of Participants | Prd (0 h) on D1 of Cy1,2,3,4,8,16 (Cy length=21 days) and thereafter on D1 of every 8th cycle, at treatment discontinuation & then every 30 days (up to 120 days) after last dose of atezolizumab (up to app 25 months) |
|
From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious & other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
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 | Arm B (Carboplatin or Cisplatin + Pemetrexed) | Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who do not experience disease progression during the induction phase will begin maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period. | 189 | 286 | 91 | 274 | 255 | 274 |
| EG001 | Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed | Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period. | 190 | 292 | 149 | 291 | 275 | 291 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| FEBRILE BONE MARROW APLASIA | Blood and lymphatic system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA Version 25.1 | Systematic Assessment |
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| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA Version 25.1 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
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| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
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| MYOCARDITIS | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
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| STRESS CARDIOMYOPATHY | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
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| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
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| TACHYCARDIA | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| AUTOIMMUNE COLITIS | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| COLITIS | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| DIVERTICULUM INTESTINAL HAEMORRHAGIC | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| ENTEROCOLITIS | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| GASTRIC PERFORATION | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| GASTROINTESTINAL DISORDER | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| OESOPHAGITIS | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| PANCREATITIS | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| PROCTITIS ULCERATIVE | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| SMALL INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| STOMATITIS | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA Version 25.1 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA Version 25.1 | Systematic Assessment |
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| DEATH | General disorders | MedDRA Version 25.1 | Systematic Assessment |
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| DISEASE SUSCEPTIBILITY | General disorders | MedDRA Version 25.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA Version 25.1 | Systematic Assessment |
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| GAIT DISTURBANCE | General disorders | MedDRA Version 25.1 | Systematic Assessment |
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| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA Version 25.1 | Systematic Assessment |
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| INFLAMMATION | General disorders | MedDRA Version 25.1 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA Version 25.1 | Systematic Assessment |
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| MUCOSAL INFLAMMATION | General disorders | MedDRA Version 25.1 | Systematic Assessment |
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| NON-CARDIAC CHEST PAIN | General disorders | MedDRA Version 25.1 | Systematic Assessment |
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| PAIN | General disorders | MedDRA Version 25.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA Version 25.1 | Systematic Assessment |
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| AUTOIMMUNE HEPATITIS | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
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| CHOLANGITIS | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
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| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
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| DRUG-INDUCED LIVER INJURY | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
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| HEPATITIS | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
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| HEPATITIS ACUTE | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
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| HEPATOTOXICITY | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
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| CYTOKINE RELEASE SYNDROME | Immune system disorders | MedDRA Version 25.1 | Systematic Assessment |
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| HYPERSENSITIVITY | Immune system disorders | MedDRA Version 25.1 | Systematic Assessment |
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| BACTERAEMIA | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| BRONCHOPULMONARY ASPERGILLOSIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| CAMPYLOBACTER GASTROENTERITIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| DIVERTICULITIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| ENCEPHALITIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| ERYSIPELAS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| H3N2 INFLUENZA | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| INFECTIOUS PLEURAL EFFUSION | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| MENINGITIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| OESOPHAGEAL CANDIDIASIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| PERIPHERAL NERVE INFECTION | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| PHARYNGITIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| PULMONARY SEPSIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| PYELONEPHRITIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| SEPSIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| SOFT TISSUE INFECTION | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| TRACHEITIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| UROSEPSIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
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| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
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| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
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| INTENTIONAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
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| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
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| SKIN INJURY | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
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| STAB WOUND | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
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| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
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| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA Version 25.1 | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA Version 25.1 | Systematic Assessment |
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| BLOOD CREATININE INCREASED | Investigations | MedDRA Version 25.1 | Systematic Assessment |
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| CREATININE RENAL CLEARANCE DECREASED | Investigations | MedDRA Version 25.1 | Systematic Assessment |
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| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| GOUT | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| FRACTURE PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| ADENOCARCINOMA GASTRIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Systematic Assessment |
| |
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Systematic Assessment |
| |
| HISTIOCYTIC NECROTISING LYMPHADENITIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Systematic Assessment |
| |
| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Systematic Assessment |
| |
| PROSTATE CANCER RECURRENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Systematic Assessment |
| |
| TUMOUR EMBOLISM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Systematic Assessment |
| |
| APHASIA | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| ATAXIA | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| BRAIN OEDEMA | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| CAROTID ARTERY OCCLUSION | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| DEVICE MALFUNCTION | Product Issues | MedDRA Version 25.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| CATATONIA | Psychiatric disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| COMPLETED SUICIDE | Psychiatric disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| CHRONIC KIDNEY DISEASE | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| GLYCOSURIA | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| NEPHRITIS ALLERGIC | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| TUBULOINTERSTITIAL NEPHRITIS | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| BRONCHIAL HYPERREACTIVITY | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| HYPERVENTILATION | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| ORGANISING PNEUMONIA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| PHARYNGEAL INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| PULMONARY HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| AORTIC EMBOLUS | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| EMBOLISM | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| PERIPHERAL ARTERY THROMBOSIS | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| PERIPHERAL ISCHAEMIA | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| THROMBOPHLEBITIS | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| VASCULITIS | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| MYELOSUPPRESSION | Blood and lymphatic system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| BILIARY OBSTRUCTION | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| CONGESTIVE HEPATOPATHY | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| GASTROENTERITIS CLOSTRIDIAL | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| LARYNGOPHARYNGITIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| VASCULAR ACCESS SITE CELLULITIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
| |
| CHANGE IN SEIZURE PRESENTATION | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| LACRIMATION INCREASED | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
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| DYSGEUSIA | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
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| PARAESTHESIA | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| HICCUPS | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA Version 25.1 | 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 | May 7, 2018 | Sep 17, 2020 | SAP_001.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 |
|---|---|
| C000594389 | atezolizumab |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| OG001 | Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed | Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period. |
|
|
| OG001 | Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed | Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period. |
|
|
| OG001 | Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed | Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period. |
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|---|---|
| Participants |
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