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The study was completed as pre-specified in the protocol. Study was terminated only for participants who were in the study even after 24 months of follow-up as specified in the protocol.
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This is a Phase IIIb, one arm, multicenter, open-label study primarily designed to evaluate the safety of atezolizumab + bevacizumab in participants with unresectable or unsuitable for locoregional treatments for metastatic HCC not previously treated with systemic therapy. As part of its secondary objectives, this study is also designed to evaluate the efficacy of atezolizumab and bevacizumab in these participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (atezolizumab plus bevacizumab) | Experimental | Participants will receive Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab will be administered intravenously at a dose of 1200 mg on Day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Discontinued Atezolizumab and/or Bevacizumab Due to Adverse Events (AE) of Grade ≥ 3 | AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavourable 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. The severity of AEs was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) with the following grades: Grade 1 = asymptomatic or mild symptoms; Grade 2 = minimal, local, or non-invasive intervention indicated; Grade 3 = severe or medically significant, but not immediately life-threatening; Grade 4 = life-threatening consequences or urgent intervention indicated and Grade 5 = death related to AE. | From Cycle 1 Day 1 up to 30 days after the final dose of the study drug or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 32 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from initiation of study treatment to death from any cause. OS was analyzed using Kaplan-Meier (K-M) methods and Greenwood's formula. Any participant who did not die during the study was censored at the last known date to be alive. | Up to 35 months |
| Progression-free Survival (PFS) |
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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 |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Elche | Elche | Alicante | 03203 | Spain | ||
| Hospital Son Llatzer |
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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Participants with unresectable hepatocellular carcinoma (HCC) who received no prior systemic treatment and were considered unsuitable for locoregional therapy were enrolled in this study to receive a combination of atezolizumab plus bevacizumab until unacceptable toxicity or loss of clinical benefit.
A total of 100 participants took part in the study in Spain from 04 May 2021 to 26 April 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atezolizumab + Bevacizumab | Participants received atezolizumab, 1200 milligrams (mg), intravenously (IV), every 3 weeks (Q3W) along with bevacizumab, 15 milligrams per kilogram (mg/kg), IV, Q3W on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit. |
| 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 16, 2023 | Apr 22, 2025 |
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| Bevacizumab | Drug | Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle. |
|
|
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 Tumours 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). PFS was analyzed using K-M methods and Greenwood's formula. Any participant who did not experience disease progression or death during the study and were censored at the last known date to be alive or without disease progression. |
| Up to 35 months |
| Objective Response Rate (ORR) | ORR = percentage of participants with a complete or partial response (CR or PR), on 2 consecutive investigator assessments ≥ 4 weeks apart in participants with measurable disease at baseline as determined by the investigator according to RECIST v1.1. CR = disappearance of all target lesions and any pathological lymph nodes must have a reduction in short axis to < 10 mm. PR = at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Participants without a post-baseline tumor assessment were considered non-responders. 95% confidence interval (CI) was derived using Wilson score intervals. Percentages have been rounded off. | Up to 35 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%, SOD must also demonstrate an absolute increase of ≥ 5 mm. TTP was analyzed using K-M methods and Greenwood's formula. Any participant who had no disease progression was censored at the last known date without disease progression. | Up to 35 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 and any pathological lymph nodes must have a 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. DOR was analyzed using K-M methods and Greenwood's formula. Any participant who did not experience disease progression or death during the study was censored at the last known date to be alive or without disease progression. | Up to 35 months |
| Percentage of Participants Who Started Second-line Treatment | Participants who started second-line of treatment were assessed. Percentages have been rounded off. | Up to 35 months |
| Change From Baseline in International Normalized Ratio (INR) | The INR is a standardized measure of the prothrombin time. Blood samples were collected from participants to evaluate coagulation parameters. | Baseline up to Cycle 42 (1 cycle = 21 days) |
| Change From Baseline in Albumin-Bilirubin (ALBI) Score | Blood samples were collected from participants to evaluate of ALBI grades. ALBI assessment grades of 1 to 3 was based on ALBI score calculation. ALBI score= log10 bilirubin (micromole per liter) [μmol/L] × 0.66 + albumin (grams per liter) [g/L] × -0.0852. ALBI score ≤ -2.60 = ALBI grade 1; -2.60 < ALBI score ≤ -1.39 = ALBI grade 2 and -1.39 < ALBI score = ALBI grade 3. | Baseline up to Cycle 42 (1 cycle = 21 days) |
| Percentage of Participants With Ascites and/or Hepatic Encephalopathy | Deterioration of hepatic function was monitored by presence of ascites and/or hepatic encephalopathy. | Up to approximately 32 months |
| Palma de Mallorca |
| Balearic Islands |
| 07198 |
| Spain |
| Corporacio Sanitaria Parc Tauli | Sabadell | Barcelona | 08208 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Provincial de Castellon | Castellon | Castellon | 12002 | Spain |
| Complejo Hospitalario Universitario de Santiago (CHUS) | Santiago de Compostela | LA Coruna | 15706 | Spain |
| Hospital de Gran Canaria Dr. Negrin | Las Palmas de Gran Canaria | LAS Palmas | 35010 | Spain |
| Hospital Universitario de Torrejon | Torrejón de Ardoz | Madrid | 28850 | Spain |
| Clinica Universitaria de Navarra | Pamplona/iruña | Navarre | 31008 | Spain |
| Hospital de Basurto | Bilbao | Vizcaya | 48013 | Spain |
| Hospital General Univ. de Alicante | Alicante | 03010 | Spain |
| Complejo Hospitalario Torrecardenas | Almería | 04009 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic i Provincial | Barcelona | 08036 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico | Jaén | 23007 | Spain |
| Hospital Lucus Augusti | Lugo | 27003 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Clinica Universidad de Navarra Madrid | Madrid | 28027 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Univ. Nuestra Señora de Valme | Seville | 41014 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Intent-to-treat Population (ITT) | ITT population included all screened participants (participants who signed the informed consent) who were eligible for the study. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all screened participants (participants who signed the informed consent) who received at least one full or partial dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Atezolizumab + Bevacizumab | Participants received atezolizumab, 1200 mg, IV, Q3W along with bevacizumab, 15 mg/kg, IV, Q3W on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit. |
| 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 Who Discontinued Atezolizumab and/or Bevacizumab Due to Adverse Events (AE) of Grade ≥ 3 | AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavourable 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. The severity of AEs was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) with the following grades: Grade 1 = asymptomatic or mild symptoms; Grade 2 = minimal, local, or non-invasive intervention indicated; Grade 3 = severe or medically significant, but not immediately life-threatening; Grade 4 = life-threatening consequences or urgent intervention indicated and Grade 5 = death related to AE. | Safety population included all screened participants (participants who signed the informed consent) who received at least one full or partial dose of study treatment. | Posted | Count of Participants | Participants | From Cycle 1 Day 1 up to 30 days after the final dose of the study drug or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 32 months) |
|
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from initiation of study treatment to death from any cause. OS was analyzed using Kaplan-Meier (K-M) methods and Greenwood's formula. Any participant who did not die during the study was censored at the last known date to be alive. | ITT population included all screened participants (participants who signed the informed consent) who were eligible for the study. | Posted | Median | 95% Confidence Interval | months | Up to 35 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 Tumours 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). PFS was analyzed using K-M methods and Greenwood's formula. Any participant who did not experience disease progression or death during the study and were censored at the last known date to be alive or without disease progression. | ITT population included all screened participants (participants who signed the informed consent) who were eligible for the study. | Posted | Median | 95% Confidence Interval | months | Up to 35 months |
|
| ||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR = percentage of participants with a complete or partial response (CR or PR), on 2 consecutive investigator assessments ≥ 4 weeks apart in participants with measurable disease at baseline as determined by the investigator according to RECIST v1.1. CR = disappearance of all target lesions and any pathological lymph nodes must have a reduction in short axis to < 10 mm. PR = at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Participants without a post-baseline tumor assessment were considered non-responders. 95% confidence interval (CI) was derived using Wilson score intervals. Percentages have been rounded off. | ITT population included all screened participants (participants who signed the informed consent) who were eligible for the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 35 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%, SOD must also demonstrate an absolute increase of ≥ 5 mm. TTP was analyzed using K-M methods and Greenwood's formula. Any participant who had no disease progression was censored at the last known date without disease progression. | ITT population included all screened participants (participants who signed the informed consent) who were eligible for the study. | Posted | Median | 95% Confidence Interval | months | Up to 35 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 and any pathological lymph nodes must have a 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. DOR was analyzed using K-M methods and Greenwood's formula. Any participant who did not experience disease progression or death during the study was censored at the last known date to be alive or without disease progression. | ITT population included all screened participants (participants who signed the informed consent) who were eligible for the study. Overall number analyzed is the number of participants with an overall response of CR or PR. | Posted | Median | 95% Confidence Interval | months | Up to 35 months |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Started Second-line Treatment | Participants who started second-line of treatment were assessed. Percentages have been rounded off. | ITT population included all screened participants (participants who signed the informed consent) who were eligible for the study. | Posted | Number | percentage of participants | Up to 35 months |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in International Normalized Ratio (INR) | The INR is a standardized measure of the prothrombin time. Blood samples were collected from participants to evaluate coagulation parameters. | Safety population included all screened participants (participants who signed the informed consent) who received at least one full or partial dose of study treatment. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | Posted | Mean | Standard Deviation | INR of prothrombin time | Baseline up to Cycle 42 (1 cycle = 21 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Albumin-Bilirubin (ALBI) Score | Blood samples were collected from participants to evaluate of ALBI grades. ALBI assessment grades of 1 to 3 was based on ALBI score calculation. ALBI score= log10 bilirubin (micromole per liter) [μmol/L] × 0.66 + albumin (grams per liter) [g/L] × -0.0852. ALBI score ≤ -2.60 = ALBI grade 1; -2.60 < ALBI score ≤ -1.39 = ALBI grade 2 and -1.39 < ALBI score = ALBI grade 3. | Safety population included all screened participants (participants who signed the informed consent) who received at least one full or partial dose of study treatment. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | Posted | Mean | Standard Deviation | score | Baseline up to Cycle 42 (1 cycle = 21 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Ascites and/or Hepatic Encephalopathy | Deterioration of hepatic function was monitored by presence of ascites and/or hepatic encephalopathy. | Safety population included all screened participants (participants who signed the informed consent) who received at least one full or partial dose of study treatment. | Posted | Number | percentage of participants | Up to approximately 32 months |
|
|
AEs and SAEs: From Cycle 1 Day 1 up to 30 days after the final dose of the study drug or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 32 months). All cause mortality: Up to 35 months
Safety population included all screened participants (participants who signed the informed consent) who received at least one full or partial dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atezolizumab + Bevacizumab: | Participants received atezolizumab, 1200 mg, IV, Q3W along with bevacizumab, 15 mg/kg, IV, Q3W on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit. | 51 | 100 | 46 | 100 | 98 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Immune-Mediated Hypothyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tumour Associated Fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Duodenal Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastric Perforation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intra-Abdominal Haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oesophageal Varices Haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatic Enzyme Increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tubulointerstitial Nephritis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemoperitoneum | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia Pneumococcal | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal Sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Biliary Sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Infective Exacerbation Of Chronic Obstructive Airways Disease | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Peritonsillar Abscess | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia Aspiration | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Spontaneous Bacterial Peritonitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatic Encephalopathy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Wound Evisceration | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oesophageal Variceal Ligation | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal Laminectomy | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peripheral Ischaemia | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Subdiaphragmatic Abscess | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Lipase Increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Amylase Increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigators are 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 | Sep 26, 2024 | Apr 22, 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 |
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|