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The Sponsor decided to discontinue the development of atezolizumab in combination with magrolimab in the AML indication.
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This Phase Ib study is designed to evaluate the safety and pharmacokinetics of atezolizumab when given in combination with Hu5F9-G4 to patients with relapsed or refractory (R/R) acute myeloid leukemia (AML).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab + Hu5F9-G4 | Experimental | An initial safety evaluation will be performed in participants with relapsed AML. If atezolizumab in combination with Hu5F9-G4 is initially safe and tolerable in participants an additional cohort with R/R AML will be evaluated to further test the safety and anti-tumor activity. If dose-limiting toxicities (DLT) are observed in >=33% of participants in this initial cohort, a dose de-escalation cohort will be enrolled. If less than 33% of enrolled and dosed participants in any given cohort experience a DLT, an expansion cohort of 15 participants will be enrolled at the highest tolerated dose for this combination. If a dose de-escalation cohort is needed, an expansion cohort will be enrolled at the lower tolerated dose for this combination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab will be administered to participants by IV infusion at a fixed dose starting on Day 22 of Cycle 1. In subsequent cycles (Cycles 2 and beyond), IV atezolizumab will be given every 2 weeks (Q2W) on Days 8 and 22 of each 28-day cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | Percentage of participants with at least one adverse event. | Up to approximately 13 months after first participant enrolled |
| Complete Remission (CR) | The CR rate is assessed as the percentage of participants who achieve a CR, complete remission with incomplete platelet recovery (CRp), complete remission with incomplete hematologic recovery (CRi), or complete remission with partial hematologic recovery (CRh) (as defined by the IWG 2003 and ELN 2010 criteria) after up to six cycles of combination therapy. | Up to approximately 3 months after first participant enrolled |
| Duration of Response (DOR) | DOR is defined as the time from the initial response (CR, CRp, CRi, CRh, or partial remission [PR]) to the time of disease progression or death, whichever occurs first | Up to approximately 3 months after first particpant enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentrations of Atezolizumab | C=cycle (cycle=28 days) ; D=day; PTFI=prior to first infusion; TDV=treatment discontinuation visit; UTA=up to approximately; M=month | C1 D22 PTFI of Hu5F9-G4 and atezolizumab, and 30 minutes after atezolizumab infusion; C2 D8 PTFI; C2 D22 PTFI; C3 D22 PTFI; C4 D22 PTFI; C8 D22 PTFI; C12 D22 PTFI; C16 D22 PTFI; TDV (up to C16 D21);120 days after final dose of atezolizumab (UTA 37M) |
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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 |
|---|---|---|---|---|---|---|
| UC Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States | ||
| Yale |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). 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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| ID | Title | Description |
|---|---|---|
| FG000 | Atezolizumab + Hu5F9-G4 | An initial safety evaluation was performed in participants with relapsed AML. If atezolizumab in combination with Hu5F9-G4 was initially safe and tolerable in participants an additional cohort with R/R AML was to be evaluated to further test the safety and anti-tumor activity. Atezolizumab was administered to participants by IV infusion at a fixed dose of 840 mg starting on Day 22 of Cycle 1. In subsequent cycles, IV atezolizumab was given every 2 weeks (Q2W) on Days 8 and 22 of each 28-day cycle. Two priming doses of 1 mg/kg of Hu5F9-G4 were administered to participants by continuous IV infusion on Days 1 and 4 of Cycle 1, followed by loading doses of 15 mg/kg IV on Day 8 and 30 mg/kg IV on Day 11. Starting on Day 15 of Cycle 1, Hu5F9-G4 maintenance was given by IV infusion at a dose of 30 mg/kg once a week (QW) of each 28-day cycle. |
| 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 | Aug 5, 2020 |
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|
| Hu5F9-G4 | Drug | Two priming doses of 1 mg/kg of Hu5F9-G4 will be administered to participants by continuous IV infusion on Days 1 and 4 of Cycle 1, followed by loading doses of 15 mg/kg IV on Day 8 and 30 mg/kg IV on Day 11. Starting on Day 15 of Cycle 1, Hu5F9-G4 maintenance will be given by IV infusion at a dose of 30 mg/kg once a week (QW) of each 28-day cycle. Dosing for de-escalation, if needed: Hu5F9-G4 will be given as two priming doses of 1 mg/kg IV on Days 1 and 4, followed by loading doses of 10 mg/kg IV on Day 8 and 15 mg/kg on Day 11. Starting on Day 15, maintenance treatment with Hu5F9-G4 will be given by IV infusion at a dose of 15 mg/kg once a week (QW). |
|
| Serum Concentrations of Hu5F9-G4 | C=cycle (cycle=28 days); D=Day; PTFI=prior to first infusion; H=hour; AEOI=after end of infusion; TDV=treatment discontinuation visit; UTA=up to approximately; M=months; E=every; T=thereafter | C1D1 PTFI&1H AEOI; C1D8 PTFI,&1H AEOI; C1D11 PTFI,&1H AEOI; C1D22 1H AEOI; C2D1 PTFI,&1H AEOI; C2D8 PTFI; C3D1 PTFI,&1H AEOI; C5D1 PTFI; C7D1 PTFI, C9D1 PTFI; C11D1 PTFI; C13D1 PTFI; C15D1 PTFI; C17D1&D1 E 2C T PTFI(UTA 37M);TDV(up to C16D21)(UTA 37M) |
| Objective Response Rate | Objective response rate is defined as the percentage of participants with a partial remission (PR) or better (i.e., CR + CRp + CRi + CRh+ PR). | Up to approximately 3 months after first participant enrolled |
| Event-Free Survival | Event-free survival is defined as the time from study entry to the date of induction treatment failure or relapse from CR, CRp, CRh, CRi, or death from any cause. | Up to approximately 3 months after first participant enrolled |
| Leukemia-Free Survival | Leukemia-free survival is defined (only for participants achieving a CR, CRp, CRh, or CRi) as the time from the date of achievement of remission (CR, CRp, or CRi) until the date of relapse from CR, CRp, CRh, CRi, or death from any cause. | Up to approximately 3 months after first participant enrolled |
| Overall Survival | Overall survival is defined as time from study entry to the date of death from any cause. | Up to approximately 13 months after first participant enrolled |
| Progression-Free Survival | Progression-free survival (Investigator) is defined as the time from the first day of study treatment to disease progression or death, whichever occurs first. | Up to approximately 3 months after first participant enrolled |
| Rate of Transfusion Independence | Rate of transfusion independence is defined as the percentage of participants who achieve transfusion independence (i.e., achieving any continuous 56-day window without requiring platelet or RBC transfusions) at any time during study treatment. | Up to approximately 3 months after first participant enrolled |
| Duration of Transfusion Independence | Duration of transfusion independence is defined as the number of consecutive days of transfusion independence, measured from 1 day after the last transfusion to disease progression or subsequent transfusion. | Up to approximately 3 months after first participant enrolled |
| Incidence of Anti-Drug Antibodies (ADAs) Against Atezolizumab During the Study Relative to the Prevalence of ADAs at Baseline | Baseline up to approximately 37 months |
| Incidence of ADAs Against Hu5F9-G4 During the Study Relative to the Prevalence of ADAs at Baseline | Baseline up to approximately 37 months |
| New Haven |
| Connecticut |
| 06511 |
| United States |
| Columbia University | New York | New York | 10032-3725 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atezolizumab + Hu5F9-G4 | An initial safety evaluation was performed in participants with relapsed AML. If atezolizumab in combination with Hu5F9-G4 was initially safe and tolerable in participants an additional cohort with R/R AML was to be evaluated to further test the safety and anti-tumor activity. Atezolizumab was administered to participants by IV infusion at a fixed dose of 840 mg starting on Day 22 of Cycle 1. In subsequent cycles, IV atezolizumab was given every 2 weeks (Q2W) on Days 8 and 22 of each 28-day cycle. Two priming doses of 1 mg/kg of Hu5F9-G4 were administered to participants by continuous IV infusion on Days 1 and 4 of Cycle 1, followed by loading doses of 15 mg/kg IV on Day 8 and 30 mg/kg IV on Day 11. Starting on Day 15 of Cycle 1, Hu5F9-G4 maintenance was given by IV infusion at a dose of 30 mg/kg once a week (QW) of each 28-day cycle. |
| 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 | Percentage of Participants With Adverse Events | Percentage of participants with at least one adverse event. | Safety population included all participants with any amount of either study drug, with participants grouped as a whole. | Posted | Number | Percentage of participants | Up to approximately 13 months after first participant enrolled |
|
|
| ||||||||||||||||||||||||||
| Primary | Complete Remission (CR) | The CR rate is assessed as the percentage of participants who achieve a CR, complete remission with incomplete platelet recovery (CRp), complete remission with incomplete hematologic recovery (CRi), or complete remission with partial hematologic recovery (CRh) (as defined by the IWG 2003 and ELN 2010 criteria) after up to six cycles of combination therapy. | The efficacy analysis population included all participants who received any amount of either study drug, with participants grouped as a whole. | Posted | Number | Percentage of participants | Up to approximately 3 months after first participant enrolled |
| ||||||||||||||||||||||||||||
| Primary | Duration of Response (DOR) | DOR is defined as the time from the initial response (CR, CRp, CRi, CRh, or partial remission [PR]) to the time of disease progression or death, whichever occurs first | The efficacy analysis population included all participants who received any amount of either study drug, with participants grouped as a whole. No participants were analyzed because no participants responded. | Posted | Up to approximately 3 months after first particpant enrolled |
|
| |||||||||||||||||||||||||||||
| Secondary | Serum Concentrations of Atezolizumab | C=cycle (cycle=28 days) ; D=day; PTFI=prior to first infusion; TDV=treatment discontinuation visit; UTA=up to approximately; M=month | Samples for PK analysis were collected, but due to the small number of participants which reduces the scientific merit of any analysis no PK assays were performed and samples were discarded, hence no PK data are available. | Posted | C1 D22 PTFI of Hu5F9-G4 and atezolizumab, and 30 minutes after atezolizumab infusion; C2 D8 PTFI; C2 D22 PTFI; C3 D22 PTFI; C4 D22 PTFI; C8 D22 PTFI; C12 D22 PTFI; C16 D22 PTFI; TDV (up to C16 D21);120 days after final dose of atezolizumab (UTA 37M) |
| ||||||||||||||||||||||||||||||
| Secondary | Serum Concentrations of Hu5F9-G4 | C=cycle (cycle=28 days); D=Day; PTFI=prior to first infusion; H=hour; AEOI=after end of infusion; TDV=treatment discontinuation visit; UTA=up to approximately; M=months; E=every; T=thereafter | Samples for PK analysis were collected, but due to the small number of participants which reduces the scientific merit of any analysis no PK assays were performed and samples were discarded, hence no PK data are available. | Posted | C1D1 PTFI&1H AEOI; C1D8 PTFI,&1H AEOI; C1D11 PTFI,&1H AEOI; C1D22 1H AEOI; C2D1 PTFI,&1H AEOI; C2D8 PTFI; C3D1 PTFI,&1H AEOI; C5D1 PTFI; C7D1 PTFI, C9D1 PTFI; C11D1 PTFI; C13D1 PTFI; C15D1 PTFI; C17D1&D1 E 2C T PTFI(UTA 37M);TDV(up to C16D21)(UTA 37M) |
| ||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate | Objective response rate is defined as the percentage of participants with a partial remission (PR) or better (i.e., CR + CRp + CRi + CRh+ PR). | The efficacy analysis population included all participants who received any amount of either study drug, with participants grouped as a whole. | Posted | Number | Percentage of participants | Up to approximately 3 months after first participant enrolled |
|
| |||||||||||||||||||||||||||
| Secondary | Event-Free Survival | Event-free survival is defined as the time from study entry to the date of induction treatment failure or relapse from CR, CRp, CRh, CRi, or death from any cause. | The efficacy analysis population included all participants who received any amount of either study drug, with participants grouped as a whole. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 3 months after first participant enrolled |
|
| ||||||||||||||||||||||||||
| Secondary | Leukemia-Free Survival | Leukemia-free survival is defined (only for participants achieving a CR, CRp, CRh, or CRi) as the time from the date of achievement of remission (CR, CRp, or CRi) until the date of relapse from CR, CRp, CRh, CRi, or death from any cause. | No participants were analyzed because no participants received an objective response. | Posted | Up to approximately 3 months after first participant enrolled |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is defined as time from study entry to the date of death from any cause. | The efficacy analysis population included all participants who received any amount of either study drug, with participants grouped as a whole. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 13 months after first participant enrolled |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-Free Survival | Progression-free survival (Investigator) is defined as the time from the first day of study treatment to disease progression or death, whichever occurs first. | The efficacy analysis population included all participants who received any amount of either study drug, with participants grouped as a whole. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 3 months after first participant enrolled |
|
| ||||||||||||||||||||||||||
| Secondary | Rate of Transfusion Independence | Rate of transfusion independence is defined as the percentage of participants who achieve transfusion independence (i.e., achieving any continuous 56-day window without requiring platelet or RBC transfusions) at any time during study treatment. | The efficacy analysis population included all participants who received any amount of either study drug, with participants grouped as a whole. | Posted | Number | Percentage of participants | Up to approximately 3 months after first participant enrolled |
|
| |||||||||||||||||||||||||||
| Secondary | Duration of Transfusion Independence | Duration of transfusion independence is defined as the number of consecutive days of transfusion independence, measured from 1 day after the last transfusion to disease progression or subsequent transfusion. | None of the participants achieved transfusion independence, hence duration of independence was not calculated. | Posted | Up to approximately 3 months after first participant enrolled |
|
| |||||||||||||||||||||||||||||
| Secondary | Incidence of Anti-Drug Antibodies (ADAs) Against Atezolizumab During the Study Relative to the Prevalence of ADAs at Baseline | Samples for ADA analysis were collected, but due to the small number of participants which reduces the scientific merit of any analysis no ADA assays were performed and samples were discarded, hence no ADA data are available. | Posted | Baseline up to approximately 37 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Incidence of ADAs Against Hu5F9-G4 During the Study Relative to the Prevalence of ADAs at Baseline | Samples for ADA analysis were collected, but due to the small number of participants which reduces the scientific merit of any analysis no ADA assays were performed and samples were discarded, hence no ADA data are available. | Posted | Baseline up to approximately 37 months |
|
|
From the first study drug to the data cutoff date: 3 November 2020 (approximately 13 months)
Safety population included all participants with any amount of either study drug, with participants grouped as a whole.
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 | Safety_Cohort | An initial safety evaluation was to be performed in participants with relapsed AML. A total of 19 participants were screened for enrollment; 8 failed screening. 13 were enrolled but only 11 received study treatment. All 11 patients enrolled in the safety cohort discontinued the study. | 9 | 11 | 10 | 11 | 10 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Cerebellar haemorrhage | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| Febrile nonhaemolytic transfusion reaction | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| Human rhinovirus test positive | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 23.1 | 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 |
| Oct 14, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| C000629291 | magrolimab |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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