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This is a Phase IIIb, one arm, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab + bevacizumab in patients with unresectable HCC who have received no prior systemic treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab + Bevacizumab | Experimental | Participants will receive atezolizumab 1200 mg intravenous (IV) infusions Q3W (dosed in 3-week cycles) + bevacizumab 15 mg/kg IV Q3W (dosed in 3-week cycles) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab 1200 mg IV infusion q3w |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 3-5 National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE V5) Bleeding/Haemorrhage | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severity of AEs was graded using NCI CTCAE v5.0. Grade 3=Severe/medically significant but not immediately life-threatening, hospitalization/prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4=Life-threatening consequences, urgent intervention indicated; Grade 5=Death related to AE. | Up to approximately 47.6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from initiation of study treatment to death from any cause. Kaplan-Meier (K-M) method was used to estimate the OS. | Up to approximately 47.6 months |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Starting Second or Further Lines of Treatment | Up to approximately 47.6 months |
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 |
|---|---|---|---|---|---|---|
| IRCCS Ospedale Casa Sollievo Della Sofferenza | San Giovanni Rotondo | Apulia | 71013 | Italy | ||
| Fondazione Pascale |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39874903 | Derived | Piscaglia F, Masi G, Martinelli E, Cabibbo G, Di Maio M, Gasbarrini A, Iavarone M, Antonuzzo L, Mazzaferro V, Ballestrero A, Garufi C, Bergamo F, Celsa C, Marino D, Tovoli F, Ponziani FR, Pressiani T, Astolfi C, Gazzoli GC, Ciardiello F, Daniele B, Rimassa L. Atezolizumab plus bevacizumab as first-line treatment of unresectable hepatocellular carcinoma: interim analysis results from the phase IIIb AMETHISTA trial. ESMO Open. 2025 Feb;10(2):104110. doi: 10.1016/j.esmoop.2024.104110. Epub 2025 Jan 27. |
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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/members/ourmembers/). 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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Participants received atezolizumab in combination with bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Of the 152 participants enrolled, three participants did not receive any treatment.
A total of 152 participants with unresectable hepatocellular carcinoma (HCC) and no prior systemic treatment took part in the study at 21 investigative sites in Italy from 25 August 2020 to 13 August 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atezolizumab + Bevacizumab | Participants received atezolizumab, 1200 milligrams (mg) as intravenous (IV) infusion, along with bevacizumab, 15 milligrams/kilogram (mg/kg), also as IV infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. |
| 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 | Jan 11, 2024 | Aug 11, 2025 |
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| Bevacizumab | Drug | Bevacizumab 15 mg/kg IV Q3W |
|
|
An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as AEs with onset date on or after the start of the first study treatment component. Number of participants with any TEAEs are reported here. |
| Up to approximately 47.6 months |
| Progression-free Survival (PFS) | PFS was defined as the time from initiation of study treatment to the first occurrence of disease progression (PD) or death from any cause (whichever occurs first), as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm). Participants alive and without any PD were censored at the last assessment date. K-M method was used to estimate the PFS. | Up to approximately 47.6 months |
| Objective Response Rate (ORR) | ORR was defined as the percentage of participants with complete or partial response (CR or PR), as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. | Up to approximately 47.6 months |
| Time to Progression (TTP) | TTP was defined as the time from initiation of study treatment to the first occurrence of PD, as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. Participants without any PD were censored at the last assessment date. K-M method was used to estimate the TTP. | Up to approximately 47.6 months |
| Duration of Response (DOR) | DOR was defined as the time from the first occurrence of a documented objective response (CR or PR) to PD or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. Participants who were alive and without any PD were censored at the last assessment date. K-M method was used to estimate the DOR. | Up to approximately 47.6 months |
| Post-progression Survival (PPS) | PPS was defined as the time from the first occurrence of PD as determined by the investigator according to RECIST v1.1 to death from any cause. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. Participants who were alive were censored at the last assessment date. K-M method was used to estimate the PPS. | Up to approximately 47.6 months |
| Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire | Participants self-reported symptomatic AEs using PRO-CTCAE, a validated item bank used to characterize presence, frequency of occurrence, severity, &/or degree of interference with daily function of 78 patient-reportable symptomatic treatment toxicities. PRO-CTCAE contains questions that are rated either dichotomously (for determination of presence vs. absence) or on a 5-point Likert scale (for determination of frequency of occurrence,severity,& interference with daily function). Treatment toxicities can occur with observable signs (e.g.,vomiting)/ non-observable symptoms (e.g.,nausea). A subset of 14 symptoms most applicable to current treatments were selected for this study. Symptoms were selected based on toxicities associated with the drug's class, mechanism of action, or mode of administration, and toxicities reported with the drug in another indication. Number of participants who reported severe symptoms per the PRO-CTCAE questionnaire on Day 1 of each cycle is reported here. | From Cycle 1 Day 1 to Cycle 63 Day 1 (1 Cycle = 21 days) |
| Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire | Participants self-reported symptomatic AEs using PRO-CTCAE, a validated item bank used to characterize presence, frequency of occurrence, severity, &/or degree of interference with daily function of 78 patient-reportable symptomatic treatment toxicities. PRO-CTCAE contains questions that are rated either dichotomously (for determination of presence vs. absence) or on a 5-point Likert scale (for determination of frequency of occurrence,severity,& interference with daily function). Treatment toxicities can occur with observable signs (e.g.,vomiting)/ non-observable symptoms (e.g.,nausea). A subset of 14 symptoms most applicable to current treatments were selected for this study. Symptoms were selected based on toxicities associated with the drug's class, mechanism of action, or mode of administration, &toxicities reported with the drug in another indication. Number of participants who reported very severe symptoms per the PRO-CTCAE questionnaire on Day 1 of each cycle is reported here. | From Cycle 1 Day 1 to Cycle 63 Day 1 (1 Cycle = 21 days) |
| Naples |
| Campania |
| 80100 |
| Italy |
| Azienda Osp Uni Seconda Università Degli Studi Di Napoli | Naples | Campania | 80131 | Italy |
| Ospedale del Mare | Naples | Campania | 80147 | Italy |
| A.O. S. Orsola Malpighi | Bologna | Emilia-Romagna | 40138 | Italy |
| Arcispedale Santa Maria Nuova | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| Azienda Ospedaliera San Camillo Forlanini | Rome | Lazio | 00151 | Italy |
| Policlinico Universitario Agostino Gemelli | Rome | Lazio | 00168 | Italy |
| A.O. Universitaria S. Martino Di Genova | Genoa | Liguria | 16132 | Italy |
| Ospedali Riuniti - Bergamo | Bergamo | Lombardy | 24128 | Italy |
| Fondazione IRCCS Ospedale Maggiore Policlinico | Milan | Lombardy | 20122 | Italy |
| Istituto Nazionale Dei Tumori | Milan | Lombardy | 20133 | Italy |
| Istituto Clinico Humanitas | Rozzano | Lombardy | 20089 | Italy |
| Azienda Ospedaliera Ordine Mauriziano di Torino | Turin | Piedmont | 10128 | Italy |
| A.O.U. Cagliari-P.O. Monserrato | Cagliari | Sardinia | 09100 | Italy |
| A.O.U. Policlinico Paolo Giaccone | Palermo | Sicily | 90127 | Italy |
| Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi | Palermo | Sicily | 90127 | Italy |
| A.O.U Careggi | Florence | Tuscany | 50124 | Italy |
| Azlenda Ospendaliero-Universitaria Pisana | Pisa | Tuscany | 56100 | Italy |
| Clinica Oncologica-Ospedali Riuniti Ancona | Torrette | Tuscany | 60020 | Italy |
| IOV - Istituto Oncologico Veneto - IRCCS | Padova | Veneto | 35128 | Italy |
| Safety Analysis Population | Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all participants who signed the informed consent form (ICF) and were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Atezolizumab + Bevacizumab | Participants received atezolizumab, 1200 mg as IV infusion, along with bevacizumab, 15 mg/kg, also as IV infusion, Q3W on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. |
| 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 | Number of Participants With Grade 3-5 National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE V5) Bleeding/Haemorrhage | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severity of AEs was graded using NCI CTCAE v5.0. Grade 3=Severe/medically significant but not immediately life-threatening, hospitalization/prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4=Life-threatening consequences, urgent intervention indicated; Grade 5=Death related to AE. | Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab. | Posted | Count of Participants | Participants | Up to approximately 47.6 months |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from initiation of study treatment to death from any cause. Kaplan-Meier (K-M) method was used to estimate the OS. | ITT population included all participants who signed the ICF and were enrolled in the study. Overall number analyzed is the number of participants with data available for analysis. | Posted | Median | 95% Confidence Interval | months | Up to approximately 47.6 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as AEs with onset date on or after the start of the first study treatment component. Number of participants with any TEAEs are reported here. | Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab. | Posted | Count of Participants | Participants | Up to approximately 47.6 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | PFS was defined as the time from initiation of study treatment to the first occurrence of disease progression (PD) or death from any cause (whichever occurs first), as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm). Participants alive and without any PD were censored at the last assessment date. K-M method was used to estimate the PFS. | ITT population included all participants who signed the ICF and were enrolled in the study. Overall number analyzed is the number of participants with data available for analysis. | Posted | Median | 95% Confidence Interval | months | Up to approximately 47.6 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR was defined as the percentage of participants with complete or partial response (CR or PR), as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. | ITT population included all participants who signed the ICF and were enrolled in the study. | Posted | Number | percentage of participants | Up to approximately 47.6 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | TTP was defined as the time from initiation of study treatment to the first occurrence of PD, as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. Participants without any PD were censored at the last assessment date. K-M method was used to estimate the TTP. | ITT population included all participants who signed the ICF and were enrolled in the study. Overall number analyzed is the number of participants with data available for analysis. | Posted | Median | 95% Confidence Interval | months | Up to approximately 47.6 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR was defined as the time from the first occurrence of a documented objective response (CR or PR) to PD or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. Participants who were alive and without any PD were censored at the last assessment date. K-M method was used to estimate the DOR. | ITT population included all participants who signed the ICF and were enrolled in the study. Overall number analyzed is the number of participants with an objective response (CR or PR). | Posted | Median | 95% Confidence Interval | months | Up to approximately 47.6 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Post-progression Survival (PPS) | PPS was defined as the time from the first occurrence of PD as determined by the investigator according to RECIST v1.1 to death from any cause. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. Participants who were alive were censored at the last assessment date. K-M method was used to estimate the PPS. | ITT population included all participants who signed the ICF and were enrolled in the study. Overall number analyzed is the number of participants with a progressive disease. | Posted | Median | 95% Confidence Interval | months | Up to approximately 47.6 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire | Participants self-reported symptomatic AEs using PRO-CTCAE, a validated item bank used to characterize presence, frequency of occurrence, severity, &/or degree of interference with daily function of 78 patient-reportable symptomatic treatment toxicities. PRO-CTCAE contains questions that are rated either dichotomously (for determination of presence vs. absence) or on a 5-point Likert scale (for determination of frequency of occurrence,severity,& interference with daily function). Treatment toxicities can occur with observable signs (e.g.,vomiting)/ non-observable symptoms (e.g.,nausea). A subset of 14 symptoms most applicable to current treatments were selected for this study. Symptoms were selected based on toxicities associated with the drug's class, mechanism of action, or mode of administration, and toxicities reported with the drug in another indication. Number of participants who reported severe symptoms per the PRO-CTCAE questionnaire on Day 1 of each cycle is reported here. | Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab. | Posted | Count of Participants | Participants | From Cycle 1 Day 1 to Cycle 63 Day 1 (1 Cycle = 21 days) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire | Participants self-reported symptomatic AEs using PRO-CTCAE, a validated item bank used to characterize presence, frequency of occurrence, severity, &/or degree of interference with daily function of 78 patient-reportable symptomatic treatment toxicities. PRO-CTCAE contains questions that are rated either dichotomously (for determination of presence vs. absence) or on a 5-point Likert scale (for determination of frequency of occurrence,severity,& interference with daily function). Treatment toxicities can occur with observable signs (e.g.,vomiting)/ non-observable symptoms (e.g.,nausea). A subset of 14 symptoms most applicable to current treatments were selected for this study. Symptoms were selected based on toxicities associated with the drug's class, mechanism of action, or mode of administration, &toxicities reported with the drug in another indication. Number of participants who reported very severe symptoms per the PRO-CTCAE questionnaire on Day 1 of each cycle is reported here. | Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab. | Posted | Count of Participants | Participants | From Cycle 1 Day 1 to Cycle 63 Day 1 (1 Cycle = 21 days) |
| ||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants Starting Second or Further Lines of Treatment | Per protocol, this is an exploratory outcome measure; therefore, the results have not been reported. | Posted | Up to approximately 47.6 months |
|
|
Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months)
Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
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 + Bevacizumab | Participants received atezolizumab, 1200 mg as IV infusion, along with bevacizumab, 15 mg/kg, also as IV infusion, Q3W on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. | 102 | 149 | 62 | 149 | 142 | 149 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Haemoperitoneum | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pancreatic haemorrhage | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Peri-implantitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Accidental exposure to product | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Leg amputation | Surgical and medical procedures | MedDRA Version 27.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 2, 2024 | Aug 11, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000068258 | Bevacizumab |
| 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 |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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