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This study will evaluate the efficacy and safety of atezolizumab with bevacizumab in combination with cisplatin and gemcitabine(CisGem), compared with atezolizumab in combination with CisGem, in participants with advanced biliary tract cancer (BTC) who have not received prior systemic therapy. Treatment will consist of a chemotherapy combination phase followed by a cancer immunotherapy (CIT)/placebo phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Atezo+Bev+CisGem, followed by Atezo+Bev | Experimental | Participants will receive atezolizumab intravenously on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status. Participants will receive bevacizumab intravenously on Day 1 of each 21-day cycle. Participants will receive cisplatin intravenously followed by gemcitabine on Days 1 and 8 of each 21-day cycle for Cycles 1-8. |
|
| Arm B: Atezo+PBO+CisGem, followed by Atezo+PBO | Active Comparator | Participants will receive atezolizumab intravenously on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status. Participants will receive placebo matching bevacizumab intravenously on Day 1 of each 21-day cycle. Participants will receive cisplatin intravenously followed by gemcitabine on Days 1 and 8 of each 21-day cycle for Cycles 1-8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first) | Randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)(up to approximately 14 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from randomization to death from any cause. | Randomization to death from any cause (up to approximately 23 months) |
| Confirmed Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Cancer Center | Duarte | California | 91010 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39423355 | Derived | Macarulla T, Ren Z, Chon HJ, Park JO, Kim JW, Pressiani T, Li D, Zhukova L, Zhu AX, Chen MH, Hack SP, Wu S, Liu B, Guan X, Lu S, Wang Y, El-Khoueiry AB. Atezolizumab Plus Chemotherapy With or Without Bevacizumab in Advanced Biliary Tract Cancer: Clinical and Biomarker Data From the Randomized Phase II IMbrave151 Trial. J Clin Oncol. 2025 Feb 10;43(5):545-557. doi: 10.1200/JCO.24.00337. Epub 2024 Oct 18. | |
| 34377158 |
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Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here ( https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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The study is considered "Completed" because all pre-planned study activities and analyses have been performed. Participants are ongoing treatment on a roll over study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | *Cycle is 21 days. Cisplatin is administered on Days 1 and 8 of each 21 day cycle for cycles 1-8. |
| FG001 | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2023 |
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|
| Bevacizumab | Drug | Bevacizumab will be administered at a dose of 15 mg/kg intravenously on Day 1 of each 21-day cycle after atezolizumab. |
|
|
| Placebo | Other | Placebo matching bevacizumab will be administered intravenously on Day 1 of each 21-day cycle after atezolizumab. |
|
| Cisplatin | Drug | Cisplatin will be administered intravenously at a dose of 25 mg/m^2 on Days 1 and 8 of each 21-day cycle for Cycles 1-8. |
|
| Gemcitabine | Drug | Gemcitabine will be administered intravenously at a dose of 1000 mg/m^2 on Days 1 and 8 of each 21-day cycle for Cycles 1-8. |
|
Confirmed ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator according to RECIST v1.1.
| Randomization up to approximately 14 months |
| Duration of Response (DOR) | DOR is defined as the time from the first occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first). | First occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)(up to approximately 14 months) |
| Disease Control Rate (DCR) | DCR is defined as the proportion of participants with a CR or a PR on two consecutive occasions >= 4 weeks apart or SD with a minimum duration of 9weeks, as determined by the investigator according to RECIST v1.1 | Randomization up to approximately 14 months |
| Time to Confirmed Deterioration (TTCD) | TTCD in patient-reported physical functioning, role functioning, and quality of life, as measured by the respective scales of the EORTC QLQ-C30 and/or EORTC IL77, and defined as the time from randomization to the first clinically meaningful deterioration that is either maintained for two consecutive assessments or followed by death from any cause within 3 weeks. | Randomization to the first clinically meaningful deterioration (up to approximately 14 months) |
| Percentage of Participants With at Least One Adverse Event | Percentage of participants with at least one adverse event. | Treatment start up to approximately 30 months. |
| Serum Concentration of Atezolizumab | Serum concentration of atezolizumab at specified timepoints. | Pre-Dose on Day 1 of Cycles 1, 2, 3, 4, 8, 12, and 16, and Post Dose Day 1 of Cycle 1 (cycle length=21 days) |
| Prevalence of ADAs to Atezolizumab | Baseline |
| Incidence of ADAs to Atezolizumab | At pre-defined intervals from administration of study drug up to approximately 14 months |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Duke Cancer Center | Durham | North Carolina | 27710 | United States |
| Sarah Cannon Research Institute / Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Nanfang Hospital, Southern Medical University | Guangzhou | 510515 | China |
| Sir Run Run Shaw Hospital Zhejiang University | Hangzhou | 310016 | China |
| Zhongshan Hospital Fudan University | Shanghai | 200032 | China |
| Queen Mary Hospital; Dept. Of Haematology & Oncology | Hong Kong | Hong Kong |
| Prince of Wales Hosp; Dept. Of Clinical Onc | Shatin | Hong Kong |
| Fondazione Pascale; U.O. Sperimentazioni Cliniche | Naples | Campania | 80100 | Italy |
| Azienda Ospedaliero Universitaria di Bologna; Istituto di Ematologia "Lorenzo e Ariosto Seragnoli" | Bologna | Emilia-Romagna | 40139 | Italy |
| Istituto Clinico Humanitas - Humanitas Cancer Center | Rozzano | Sicily | 20089 | Italy |
| IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II | Padova | Veneto | 35128 | Italy |
| SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej | Bytom | 41-902 | Poland |
| Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii | Gdansk | 80-214 | Poland |
| Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii | Koszalin | 75-581 | Poland |
| NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii | Warsaw | 02-034 | Poland |
| Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii | Wroc?aw | 53-413 | Poland |
| FSBI "National Medical Research Center of Oncology N.N. Blokhin? | Moscow | Moscow Oblast | 115478 | Russia |
| First Moscow State Medical University n.a. I.M. Sechenov | Moscow | Moscow Oblast | 119991 | Russia |
| SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM" | Moskva | Moscow Oblast | 111123 | Russia |
| GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology) | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| CHA Bundang Medical Center | Gyeonggi-do | 13496 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 463-707 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Complejo Hospitalario de Navarra; Servicio de Oncologia | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitari Vall d'Hebron; Oncology | Barcelona | 08035 | Spain |
| Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | 28034 | Spain |
| Complejo Hospitalario de Orense; Servicio de Oncologia | Ourense | 32005 | Spain |
| Hospital Universitario Miguel Servet; Servicio Oncologia | Zaragoza | 50009 | Spain |
| National Taiwan Uni Hospital; Dept of Oncology | Taipei | 100 | Taiwan |
| Taipei Veterans General Hospital; Department of Oncology | Taipei | 112201 | Taiwan |
| Maharaj Nakorn Chiang Mai Hosp; Oncology Unit | Chiang Mai | 50200 | Thailand |
| Srinagarind Hospital; Medical Oncology Unit | Khon Kaen | 40002 | Thailand |
| Sunpasitthiprasong Hospital; Oncology and/or Hematology | Ubon Ratchathani | 34000 | Thailand |
| Adana Ac?badem Hospital Oncology Department | Adana | 01130 | Turkey (Türkiye) |
| Memorial Ankara Hastanesi | Ankara | 06520 | Turkey (Türkiye) |
| Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department | Malatya | 44280 | Turkey (Türkiye) |
| Koc Universitesi Hastanesi; T?bbi Onkoloji | Zeyt?nburnu | 34010 | Turkey (Türkiye) |
| SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU | Kharkiv | Kharkiv Governorate | 61018 | Ukraine |
| ?Kharkov Regional Oncology Center | Kharkiv | Kharkiv Governorate | 61070 | Ukraine |
| SI "Shalimov National Institute of Surgery and Transplantation" of Nat.Acad of Med.Sci of Ukraine | Kyiv | KIEV Governorate | 03126 | Ukraine |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| Royal Free Hospital | London | NW3 2QS | United Kingdom |
| Churchill Hospital | Oxford | OX3 7LJ | United Kingdom |
| Royal Marsden Hospital (Sutton) | Sutton | SM2 5PT | United Kingdom |
| Derived |
| Hack SP, Verret W, Mulla S, Liu B, Wang Y, Macarulla T, Ren Z, El-Khoueiry AB, Zhu AX. IMbrave 151: a randomized phase II trial of atezolizumab combined with bevacizumab and chemotherapy in patients with advanced biliary tract cancer. Ther Adv Med Oncol. 2021 Jul 31;13:17588359211036544. doi: 10.1177/17588359211036544. eCollection 2021. |
*Cycle is 21 days. Cisplatin is administered on Days 1 and 8 of each 21 day cycle for cycles 1-8. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | *Cycle is 21 days. Cisplatin is administered on Days 1 and 8 of each 21 day cycle for cycles 1-8. |
| BG001 | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | *Cycle is 21 days. Cisplatin is administered on Days 1 and 8 of each 21 day cycle for cycles 1-8. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 |
|
| 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) | PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first) | Analysis was performed on the Intent-to-treat (ITT) population, defined as all randomized participants, regardless of whether they received the assigned treatment or not, were included for analyses with participants grouped according to the treatment assigned at randomization. | Posted | Median | 95% Confidence Interval | Months | Randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)(up to approximately 14 months) |
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| Secondary | Overall Survival (OS) | OS is defined as the time from randomization to death from any cause. | Analysis was performed on the Intent-to-treat (ITT) population, defined as all randomized participants, regardless of whether they received the assigned treatment or not, were included for analyses with participants grouped according to the treatment assigned at randomization. | Posted | Median | 95% Confidence Interval | Months | Randomization to death from any cause (up to approximately 23 months) |
|
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| Secondary | Confirmed Objective Response Rate (ORR) | Confirmed ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator according to RECIST v1.1. | Analysis was performed on the Intent-to-treat (ITT) population, defined as all randomized participants, regardless of whether they received the assigned treatment or not, were included for analyses with participants grouped according to the treatment assigned at randomization. | Posted | Number | Percentage of participants | Randomization up to approximately 14 months |
|
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| Secondary | Duration of Response (DOR) | DOR is defined as the time from the first occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first). | Analysis was performed on the Intent-to-treat (ITT) population, defined as all randomized participants, regardless of whether they received the assigned treatment or not, were included for analyses with participants grouped according to the treatment assigned at randomization. | Posted | Median | 95% Confidence Interval | Months | First occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)(up to approximately 14 months) |
|
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| Secondary | Disease Control Rate (DCR) | DCR is defined as the proportion of participants with a CR or a PR on two consecutive occasions >= 4 weeks apart or SD with a minimum duration of 9weeks, as determined by the investigator according to RECIST v1.1 | Analysis was performed on the Intent-to-treat (ITT) population, defined as all randomized participants, regardless of whether they received the assigned treatment or not, were included for analyses with participants grouped according to the treatment assigned at randomization. | Posted | Number | Percentage of participants | Randomization up to approximately 14 months |
|
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| Secondary | Time to Confirmed Deterioration (TTCD) | TTCD in patient-reported physical functioning, role functioning, and quality of life, as measured by the respective scales of the EORTC QLQ-C30 and/or EORTC IL77, and defined as the time from randomization to the first clinically meaningful deterioration that is either maintained for two consecutive assessments or followed by death from any cause within 3 weeks. | Analysis was performed on the Intent-to-treat (ITT) population, defined as all randomized participants, regardless of whether they received the assigned treatment or not, were included for analyses with participants grouped according to the treatment assigned at randomization. | Posted | Median | 95% Confidence Interval | Months | Randomization to the first clinically meaningful deterioration (up to approximately 14 months) |
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| Secondary | Percentage of Participants With at Least One Adverse Event | Percentage of participants with at least one adverse event. | Safety analyses will be performed on the safety-evaluable population, which is defined as all randomized participants who receive any amount of any component of protocol treatment. | Posted | Number | Percentage of participants | Treatment start up to approximately 30 months. |
|
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| Secondary | Serum Concentration of Atezolizumab | Serum concentration of atezolizumab at specified timepoints. | The PK analysis population consisted of all participants with at least 1 PK assessment. | Posted | Mean | Standard Deviation | μg/ mL | Pre-Dose on Day 1 of Cycles 1, 2, 3, 4, 8, 12, and 16, and Post Dose Day 1 of Cycle 1 (cycle length=21 days) |
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| Secondary | Prevalence of ADAs to Atezolizumab | The immunogenicity analysis population consist of all participants with at least 1 postbaseline ADA assessment. Participants are grouped according to treatment received. No data were collected because the study was discontinued before any measurements were completed. | Posted | Baseline |
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| Secondary | Incidence of ADAs to Atezolizumab | The immunogenicity analysis population consist of all participants with at least 1 postbaseline ADA assessment. Participants are grouped according to treatment received. No data were collected because the study was discontinued before any measurements were completed. | Posted | At pre-defined intervals from administration of study drug up to approximately 14 months |
|
|
From the first study drug until the data cut-off on 25 August 2023 (up to approximately 30 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 study drug.
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| 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: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | *Cycle is 21 days. Cisplatin is administered on Days 1 and 8 of each 21 day cycle for cycles 1-8. | 51 | 83 | 43 | 81 | 81 | 81 |
| EG001 | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | *Cycle is 21 days. Cisplatin is administered on Days 1 and 8 of each 21 day cycle for cycles 1-8. | 49 | 79 | 36 | 78 | 77 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Duodenal perforation | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Biliary dilatation | Hepatobiliary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hepatobiliary disease | Hepatobiliary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Recurrent pyogenic cholangitis | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Blood culture positive | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Brain stem infarction | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Prostatic obstruction | Reproductive system and breast disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Ocular myasthenia | Eye disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Ulcer haemorrhage | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Gallbladder obstruction | Hepatobiliary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Haematological infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | 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 |
| May 11, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000068258 | Bevacizumab |
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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 |
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
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|