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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001409-34 | EudraCT Number |
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This is a Phase III/IV, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in participants with Stage IIIb or Stage IV NSCLC who have progressed after standard systemic chemotherapy (including if given in combination with anti-programmed cell death protein 1 [anti-PD-1] therapy, after anti-PD-1 as monotherapy, or after tyrosine kinase inhibitor [TKI] therapy). The study will consist of a Screening Period, a Treatment Period, a Treatment Discontinuation Visit, and a Follow-Up Period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab | Experimental | Participants with Stage IIIb or State IV NSCLC who have progressed after standard systemic chemotherapy will receive atezolizumab until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Participants will receive 1200 milligrams (mg) of atezolizumab administered by intravenous infusion on Day 1 of every 3-week cycle until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs. | Baseline up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Alive 2 Years After Initiation of Treatment | The overall survival (OS) rate at 2 years, was defined as the percentage of participants remaining alive 2 years after initiation of study treatment. | Baseline up to Year 2 |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Aleman | Caba | C1118AAT | Argentina | |||
| Centro Oncologico Riojano Integral (CORI) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36450379 | Derived | Ardizzoni A, Azevedo S, Rubio-Viqueira B, Rodriguez-Abreu D, Alatorre-Alexander J, Smit HJM, Yu J, Syrigos K, Hoglander E, Kaul M, Tolson J, Hu Y, Vollan HK, Newsom-Davis T. Final results from TAIL: updated long-term efficacy of atezolizumab in a diverse population of patients with previously treated advanced non-small cell lung cancer. J Immunother Cancer. 2022 Nov;10(11):e005581. doi: 10.1136/jitc-2022-005581. | |
| 33737339 |
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Four enrolled participants died without receiving study treatment.
Participants were enrolled at 111 sites across 24 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atezolizumab | Participants with Stage IIIb or State IV NSCLC who had progressed after standard systemic chemotherapy received atezolizumab until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurred first). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 23, 2021 | Mar 15, 2023 |
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|
OS was defined as the time (in months) from initiation of study treatment to death from any cause. |
| Baseline up to death (up to 4 years) |
| Progression-Free Survival (PFS) as Evaluated By the Investigator in Accordance With Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v.1.1) | PFS was defined as the time (in months) from initiation of study treatment to the first documented disease progression or death from any cause, whichever occurred first. PFS was evaluated by the investigator according to RECIST v1.1. | Baseline up to disease progression or death whichever occurs first (up to 4 years) |
| EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire - Mobility Item | The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a Visual Analogue Scale (VAS) that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the mobility item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'. | Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years) |
| EQ-5D-5L Questionnaire - Self-Care Item | The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the self-care item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'. | Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years) |
| EQ-5D-5L Questionnaire - Usual Activities Item | The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the usual activities item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'. | Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years) |
| EQ-5D-5L Questionnaire - Pain/Discomfort Item | The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the pain/discomfort item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'. | Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years) |
| EQ-5D-5L Questionnaire - Anxiety/Depression Item | The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the anxiety/depression item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'. | Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years) |
| EQ-5D-5L Questionnaire - VAS Scores | The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Values presented after baseline represent the change from baseline. | Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years) |
| European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Supplemental Lung Cancer Module (EORTC QLQ-LC13) | The EORTC QLQ-LC13 consisted of 13 items that address key lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related adverse effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. The dysphagia scale is multi-item, while the rest are single-item scales. The scales are linearly transformed so that each score has a range from 0 to 100. A high scale score represents a higher response level (e.g. a high score for global health status represents a high QoL). A high score for the symptom scale represents a high level of symptoms. A >=10-point change in the EORTC scale score was perceived by participants as clinically significant. Values presented after baseline represent the change from baseline. | Day 1 of first 3 cycles (21-day cycle), then every 6 weeks for 48 weeks; thereafter every 9 weeks until disease progression or until treatment discontinuation (up to 4 years) |
| Progression-Free Survival as Evaluated By the Investigator in Accordance With Modified RECIST | PFS was defined as the time (in months) from initiation of study treatment to the first documented disease progression or death from any cause, whichever occurred first. PFS was evaluated by the investigator according to modified RECIST. | Baseline up to disease progression or death whichever occurs first (up to 4 years) |
| Percentage of Participants Alive 3 Years After Initiation of Treatment | The OS rate at 3 years, was defined as the percentage of participants remaining alive 3 years after initiation of study treatment. | Baseline up to Year 3 |
| Percentage of Participants With Objective Reponse as Assessed by the Investigator According to RECIST v1.1 | Objective response rate (ORR), according to RECIST v1.1, was defined as the percentage of participants with a confirmed best overall response (BOR), either complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1. | Baseline up to disease progression or death whichever occurs first (up to 4 years) |
| Percentage of Participants With Objective Reponse as Assessed by the Investigator According to Modified RECIST | The investigator-assessed ORR was defined as the proportion of participants whose confirmed BOR is either a PR or CR per modified RECIST. | Baseline up to disease progression or death whichever occurs first (up to 4 years) |
| Duration of Response as Assessed by the Investigator According to RECIST v.1.1 | DOR was defined as the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first reported) to documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first, among participants who had a best overall response as CR or PR. | From date of first objective response up to disease progression or death whichever occurs first (up to 4 years) |
| Duration of Response as Assessed by the Investigator According to Modified RECIST | DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurred first. | From date of first objective response up to disease progression or death whichever occurs first (up to 4 years) |
| La Rioja |
| F5300COE |
| Argentina |
| CETUS Hospital Dia Oncologia | Uberaba | Minas Gerais | 38082-049 | Brazil |
| Hospital das Clinicas - UFRGS | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Hospital Alemao Oswaldo Cruz | São Paulo | São Paulo | 01327-001 | Brazil |
| Beijing Hospital | Beijing | 100006 | China |
| Chinese PLA General Hospital | Beijing | 100853 | China |
| Shandong Cancer Hospital | Jinan | 250117 | China |
| First Affiliated Hospital of Soochow University | Suzhou | 215006 | China |
| Henan Cancer Hospital | Zhengzhou | 450008 | China |
| Organizacion Sanitas Internacional | Bogota, D.C. | 111321 | Colombia |
| Clinica CIMCA | San José | 10103 | Costa Rica |
| Sjællands Universitetshospital, Næstved; Onkologisk Afdeling | Næstved | 4700 | Denmark |
| Odense Universitetshospital, Onkologisk Afdeling R | Odense C | 5000 | Denmark |
| Vejle Sygehus; Onkologisk Afdeling | Vejle | 7100 | Denmark |
| Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine | Athens | 115 22 | Greece |
| Uoa Sotiria Hospital; Oncology | Athens | 115 27 | Greece |
| Agioi Anargyroi; 3Rd Dept. of Medical Oncology | Athens | 145 64 | Greece |
| Univ General Hosp Heraklion; Medical Oncology | Heraklion | 711 10 | Greece |
| University Hospital of Patras Medical Oncology | Pátrai | 265 04 | Greece |
| Diavalkaniko Hospital | Thessaloniki | 570 01 | Greece |
| Oncomedica | Guatemala City | 01010 | Guatemala |
| Ospedale Regionale Umberto Parini; S.C. Oncologia | Aosta | Aosta Valley | 11100 | Italy |
| Ist. Ricovero e Cura a Carattere Scientifico-Centro Rif. Oncologico della Basilica | Rionero in Vulture (PZ) | Basilicate | 85028 | Italy |
| Campus Universitario S.Venuta; Centro Oncologico T.Campanella | Catanzaro | Calabria | 88100 | Italy |
| Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica | Bologna | Emilia-Romagna | 40138 | Italy |
| Arcispedale Santa Maria Nuova; Medicina Nucleare | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche | Rome | Lazio | 00161 | Italy |
| AZ. Ospedaliera San Giovanni - Addolorata | Rome | Lazio | 00184 | Italy |
| Cliniche Gavazzeni S.p.A.; Dip. di Oncologia Pneumologica ed Urologica | Bergamo | Lombardy | 24125 | Italy |
| ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica | Brescia | Lombardy | 25123 | Italy |
| Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia | Milan | Lombardy | 20162 | Italy |
| Ospedale Oncologico A.Businco; Div. Oncologia Medica II | Cagliari | Sardinia | 09121 | Italy |
| Ospedale Cannizzaro, Oncologia | Catania | Sicily | 95126 | Italy |
| Ospedali Riuniti Di Ancona; Oncology | Ancona | The Marches | 60121 | Italy |
| Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia | Florence | Tuscany | 50134 | Italy |
| Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare | Pisa | Tuscany | 56124 | Italy |
| ULSS2 Marca Trevigiana; UOC Oncologia Medica - Distretto di Treviso | Treviso | Veneto | 31100 | Italy |
| Pauls Stradins Clinical University Hospital | R?ga | LV-1002 | Latvia |
| Riga East Clinical University Hospital Latvian Oncology Centre | Riga | LV-1079 | Latvia |
| Hotel Dieu de France; Oncology | Beirut | 2063 1111 | Lebanon |
| Bellevue Medical Center | El-Metn | 2241 | Lebanon |
| University Malaya Medical Centre; Clinical Oncology Unit, | Kuala Lumpur | FED. Territory of Kuala Lumpur | 59100 | Malaysia |
| Institute Kanser Negara (IKN) | Putrajaya | FED. Territory of Kuala Lumpur | 62250 | Malaysia |
| Hospital Pulau Pinang; Jabatan Respiratori | George Town | Pulau Pinang | 10450 | Malaysia |
| Mount Miriam Cancer Hospital | Pulau Pinang | Pulau Pinang | 11200 | Malaysia |
| Hospital Umum Sarawak; Oncology and Radiotherapy | Kuching | Sarawak | 93586 | Malaysia |
| Health Pharma Professional Research | Mexico City | Mexico CITY (federal District) | 03100 | Mexico |
| Centro Oncologico Internacional | Mexico City | Mexico CITY (federal District) | 04700 | Mexico |
| Oaxaca Site Management Organization | Oaxaca City | Oaxaca | 68000 | Mexico |
| Oncologico Potosino | San Luis Potosí City | San Luis Potosí | 78209 | Mexico |
| Investigacion Clinica Merida | Mérida | Yucatán | 97125 | Mexico |
| Clinique le Littoral | Casablanca | 20100 | Morocco |
| Centre Hospitalier Universitaire Hassan II | Fes | 30000 | Morocco |
| Institut National D'oncologie Sidi Med Benabdellah | Rabat | 6213 | Morocco |
| Meander Medisch Centrum | Amersfoort | 3813 TZ | Netherlands |
| Ziekenhuis Rijnstate | Arnhem | 6815 AD | Netherlands |
| Amphia Ziekenhuis; Afdeling Longziekten | Breda | 4818 CK | Netherlands |
| Tergooiziekenhuizen, loc. Hilversum | Hilversum | 1213 HX | Netherlands |
| UMC Radboud Nijmegen | Nijmegen | 6500 HB | Netherlands |
| Isala | Zwolle | 8025 AB | Netherlands |
| The Panama Clinic | Panama City | 0832 | Panama |
| Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica | Arequipa | 5154 | Peru |
| Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional | Lima | 15036 | Peru |
| University of Perpetual Help System DALTA Medical Center | Las Piñas | 1740 | Philippines |
| The Medical City Hospital; Cancer Research Room | Pasig | 1605 | Philippines |
| East Avenue Medical Center | Quezon City | 1100 | Philippines |
| Narodowy Instytut Onkologii Oddzial Gliwice; II Klinika Radioterapii i Chemioterapii | Gliwice | 44-101 | Poland |
| Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie | Olsztyn | 10-357 | Poland |
| Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii | Otwock | 05-400 | Poland |
| Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna | Poznan | 60-569 | Poland |
| Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers | Warsaw | 02-781 | Poland |
| University Clinic Golnik | Golnik | 4204 | Slovenia |
| Hospital Universitario Son Espases; Servicio de Oncologia | Palma de Mallorca | Balearic Islands | 07014 | Spain |
| Hospital Universitario Marques de Valdecilla; Servicio de Oncologia | Santander | Cantabria | 39008 | Spain |
| Hospital Provincial de Castellon; Servicio de Oncologia | Castellon | Castellon | 12002 | Spain |
| Hospital Universitario Reina Sofia; Servicio de Oncologia | Córdoba | Cordoba | 14004 | Spain |
| Hospital de Donostia; Servicio de Oncologia Medica | Donostia / San Sebastian | Guipuzcoa | 20080 | Spain |
| Complejo Hospitalario Universitario Insular?Materno Infantil; Servicio de Oncologia | Las Palmas de Gran Canaria | LAS Palmas | 35016 | Spain |
| Hospital Universitario Puerta de Hierro; Servicio de Oncologia | Majadahonda | Madrid | 28222 | Spain |
| Hospital Quiron de Madrid; Servicio de Oncologia | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Infanta Sofia; Servico de Oncologia | San Sebastián de los Reyes | Madrid | 28702 | Spain |
| Complejo Hospitalario de Navarra; Servicio de Oncologia | Pamplona | Navarre | 31008 | Spain |
| Hospital Univ. Central de Asturias; Servicio de Oncologia | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Universitario de Canarias;servicio de Oncologia | San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Hospital General Univ. de Alicante; Servicio de Oncologia | Alicante | 3010 | Spain |
| Hospital del Mar; Servicio de Oncologia | Barcelona | 08003 | Spain |
| Hospital Clínic i Provincial; Servicio de Hematología y Oncología | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia | Barcelona | 08041 | Spain |
| Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica | Girona | 17007 | Spain |
| Hospital Universitario Virgen de las Nieves; Servicio de Oncologia | Granada | 18014 | Spain |
| Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia | Jaén | 23007 | Spain |
| Hospital Lucus Augusti; Servicio de Oncologia | Lugo | 27003 | Spain |
| Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | 28041 | Spain |
| Hospital Universitario La Paz; Servicio de Oncologia | Madrid | 28046 | Spain |
| Hospital Universitario Virgen del Rocio; Servicio de Oncologia | Seville | 41013 | Spain |
| Hospital General Universitario de Valencia; Servicio de oncologia | Valencia | 46014 | Spain |
| Hospital Universitario la Fe; Servicio de Oncologia | Valencia | 46026 | Spain |
| Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia | Zaragoza | 50009 | Spain |
| Sahlgrenska Universitetssjukhuset, Lungmedicinkliniken | Gothenburg | 41345 | Sweden |
| Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01 | Stockholm | 171 76 | Sweden |
| Uppsala University Hospital; Department of Oncology | Uppsala | 751 85 | Sweden |
| Tawam Hospital | Al Ain City | 15258 | United Arab Emirates |
| Royal United Hospital | Bath | BA1 3NG | United Kingdom |
| Birmingham Heartlands Hospital ; Department of Respiratory Medicine (Rm 30) | Birmingham | B9 5SS | United Kingdom |
| Castle Hill Hospital; The Queen's Centre for Oncology & Haematology | Hull | HU16 5JQ | United Kingdom |
| Forth Valley Royal Hospital ; Oncology Department | Larbert | FK5 4QE | United Kingdom |
| Chelsea & Westminster Hospital | London | SW10 9TH | United Kingdom |
| Mount Vernon Cancer Centre | Northwood | HA6 2RN | United Kingdom |
| New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
| Derived |
| Ardizzoni A, Azevedo S, Rubio-Viqueira B, Rodriguez-Abreu D, Alatorre-Alexander J, Smit HJM, Yu J, Syrigos K, Trunzer K, Patel H, Tolson J, Cardona A, Perez-Moreno PD, Newsom-Davis T. Primary results from TAIL: a global single-arm safety study of atezolizumab monotherapy in a diverse population of patients with previously treated advanced non-small cell lung cancer. J Immunother Cancer. 2021 Mar;9(3):e001865. doi: 10.1136/jitc-2020-001865. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Atezolizumab | Participants with Stage IIIb or State IV NSCLC who had progressed after standard systemic chemotherapy received atezolizumab until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurred first). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region | Count of Participants | Participants |
| |||||||||||||||||||||||
| ECOG Performance Status | ECOG Performance Status is graded from 0-5 with a lower number representing no or limited impact on daily living activities and a higher number represents greater impact on daily living activities. | Count of Participants | Participants |
| ||||||||||||||||||||||
| Smoking Status | Count of Participants | Participants |
| |||||||||||||||||||||||
| eGFR (mL/min/1.73 m^2) at baseline | Count of Participants | Participants |
|
| 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 | Percentage of Participants With Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs. | The safety population was based on all participants who received any dose of atezolizumab during the study treatment. | Posted | Count of Participants | Participants | Baseline up to 4 years |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Alive 2 Years After Initiation of Treatment | The overall survival (OS) rate at 2 years, was defined as the percentage of participants remaining alive 2 years after initiation of study treatment. | The safety population was based on all participants who received any dose of atezolizumab during the study treatment. | Posted | Number | Percentage of Participants | Baseline up to Year 2 |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time (in months) from initiation of study treatment to death from any cause. | The safety population was based on all participants who received any dose of atezolizumab during the study treatment. | Posted | Median | 95% Confidence Interval | Months | Baseline up to death (up to 4 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) as Evaluated By the Investigator in Accordance With Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v.1.1) | PFS was defined as the time (in months) from initiation of study treatment to the first documented disease progression or death from any cause, whichever occurred first. PFS was evaluated by the investigator according to RECIST v1.1. | The safety population was based on all participants who received any dose of atezolizumab during the study treatment. This was a single-arm study. The study population was participants with Stage IIIB or Stage IV NSCLC. The primary objective of this study was to understand the safety in this participant population (without distinction of Stage IIIB and IV) and it was not planned to analyze them separately as per the protocol. | Posted | Median | 95% Confidence Interval | Months | Baseline up to disease progression or death whichever occurs first (up to 4 years) |
|
| ||||||||||||||||||||||||||
| Secondary | EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire - Mobility Item | The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a Visual Analogue Scale (VAS) that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the mobility item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'. | The safety population was based on all participants who received any dose of atezolizumab during the study treatment. Number analyzed are unique number of participants out of all the assessed participants who were evaluable at specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Count of Participants | Participants | Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years) |
| ||||||||||||||||||||||||||||
| Secondary | EQ-5D-5L Questionnaire - Self-Care Item | The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the self-care item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'. | The safety population was based on all participants who received any dose of atezolizumab during the study treatment. Number analyzed are unique number of participants out of all the assessed participants who were evaluable at specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Count of Participants | Participants | Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years) |
| ||||||||||||||||||||||||||||
| Secondary | EQ-5D-5L Questionnaire - Usual Activities Item | The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the usual activities item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'. | The safety population was based on all participants who received any dose of atezolizumab during the study treatment. Number analyzed are unique number of participants out of all the assessed participants who were evaluable at specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Count of Participants | Participants | Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years) |
| ||||||||||||||||||||||||||||
| Secondary | EQ-5D-5L Questionnaire - Pain/Discomfort Item | The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the pain/discomfort item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'. | The safety population was based on all participants who received any dose of atezolizumab during the study treatment. Number analyzed are unique number of participants out of all the assessed participants who were evaluable at specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Count of Participants | Participants | Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years) |
| ||||||||||||||||||||||||||||
| Secondary | EQ-5D-5L Questionnaire - Anxiety/Depression Item | The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the anxiety/depression item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'. | The safety population was based on all participants who received any dose of atezolizumab during the study treatment. Number analyzed are unique number of participants out of all the assessed participants who were evaluable at specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Count of Participants | Participants | Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years) |
| ||||||||||||||||||||||||||||
| Secondary | EQ-5D-5L Questionnaire - VAS Scores | The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Values presented after baseline represent the change from baseline. | The safety population was based on all participants who received any dose of atezolizumab during the study treatment. Number analyzed are unique number of participants out of all the assessed participants who were evaluable at specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years) |
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| Secondary | European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Supplemental Lung Cancer Module (EORTC QLQ-LC13) | The EORTC QLQ-LC13 consisted of 13 items that address key lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related adverse effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. The dysphagia scale is multi-item, while the rest are single-item scales. The scales are linearly transformed so that each score has a range from 0 to 100. A high scale score represents a higher response level (e.g. a high score for global health status represents a high QoL). A high score for the symptom scale represents a high level of symptoms. A >=10-point change in the EORTC scale score was perceived by participants as clinically significant. Values presented after baseline represent the change from baseline. | The safety population was based on all participants who received any dose of atezolizumab during the study treatment. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 of first 3 cycles (21-day cycle), then every 6 weeks for 48 weeks; thereafter every 9 weeks until disease progression or until treatment discontinuation (up to 4 years) |
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| Secondary | Progression-Free Survival as Evaluated By the Investigator in Accordance With Modified RECIST | PFS was defined as the time (in months) from initiation of study treatment to the first documented disease progression or death from any cause, whichever occurred first. PFS was evaluated by the investigator according to modified RECIST. | The safety population was based on all participants who received any dose of atezolizumab during the study treatment. This was a single-arm study. The study population was participants with Stage IIIB or Stage IV NSCLC. The primary objective of this study was to understand the safety in this participant population (without distinction of Stage IIIB and IV) and it was not planned to analyze them separately as per the protocol. | Posted | Median | 95% Confidence Interval | Months | Baseline up to disease progression or death whichever occurs first (up to 4 years) |
|
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| Secondary | Percentage of Participants Alive 3 Years After Initiation of Treatment | The OS rate at 3 years, was defined as the percentage of participants remaining alive 3 years after initiation of study treatment. | The safety population was based on all participants who received any dose of atezolizumab during the study treatment. | Posted | Number | Percentage of Participants | Baseline up to Year 3 |
|
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| Secondary | Percentage of Participants With Objective Reponse as Assessed by the Investigator According to RECIST v1.1 | Objective response rate (ORR), according to RECIST v1.1, was defined as the percentage of participants with a confirmed best overall response (BOR), either complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1. | The safety population was based on all participants who received any dose of atezolizumab during the study treatment. | Posted | Number | Percentage of Participants | Baseline up to disease progression or death whichever occurs first (up to 4 years) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Reponse as Assessed by the Investigator According to Modified RECIST | The investigator-assessed ORR was defined as the proportion of participants whose confirmed BOR is either a PR or CR per modified RECIST. | The safety population was based on all participants who received any dose of atezolizumab during the study treatment. | Posted | Number | Percentage of Participants | Baseline up to disease progression or death whichever occurs first (up to 4 years) |
|
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| Secondary | Duration of Response as Assessed by the Investigator According to RECIST v.1.1 | DOR was defined as the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first reported) to documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first, among participants who had a best overall response as CR or PR. | The safety population was based on all participants who received any dose of atezolizumab during the study treatment. | Posted | Median | 95% Confidence Interval | Months | From date of first objective response up to disease progression or death whichever occurs first (up to 4 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response as Assessed by the Investigator According to Modified RECIST | DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurred first. | The safety population was based on all participants who received any dose of atezolizumab during the study treatment. | Posted | Median | 95% Confidence Interval | Months | From date of first objective response up to disease progression or death whichever occurs first (up to 4 years) |
|
|
Baseline up to 4 years
The ITT population consisted of 619 enrolled participants and the safety population consisted of the 615 participants who received at least one dose of atezolizumab, which was the primary analysis population for the study. Four enrolled participants died before receiving the treatment and were excluded from the safety population. They are included in the all-cause mortality count.
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 | Atezolizumab | Participants with Stage IIIb or State IV NSCLC who had progressed after standard systemic chemotherapy received atezolizumab until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurred first). | 474 | 619 | 198 | 615 | 480 | 615 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Endocarditis noninfective | Cardiac disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Primary adrenal insufficiency | Endocrine disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Death | General disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Device related thrombosis | General disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v. 24 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Hepatic lesion | Hepatobiliary disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Infected fistula | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Pleural infection | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Pneumonia escherichia | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v. 24 | Systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA v. 24 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v. 24 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v. 24 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA v. 24 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA v. 24 | Systematic Assessment |
| |
| Spinal cord injury | Injury, poisoning and procedural complications | MedDRA v. 24 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA v. 24 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v. 24 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v. 24 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA v. 24 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v. 24 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v. 24 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v. 24 | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v. 24 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v. 24 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v. 24 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v. 24 | Systematic Assessment |
| |
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Bronchial haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Limb operation | Surgical and medical procedures | MedDRA v. 24 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA v. 24 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v. 24 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v. 24 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v. 24 | 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_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 17, 2019 | Mar 15, 2023 | 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 |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| LATAM (Latin America) |
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| ECOG performance status 2 (ambulatory and capable of selfcare; unable to carry out work activities) |
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| Previous |
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| 60-<90 |
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| >=90 |
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| Missing |
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