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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002467-42 | EudraCT Number |
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This study will evaluate the safety, efficacy, pharmacokinetics and immunogenicity of induction treatment consisting of atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma (FL), followed by maintenance treatment with atezolizumab plus obinutzumab plus lenalidomide in patients who achieve a complete response (CR), a partial response (PR), or stable disease at end of induction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab-G-lena 15mg | Experimental | Participants were administered obinutuzumab, Atezolizumab, and 15 mg of Lenalidomide. |
|
| Atezolizumab-G-lena 20mg | Experimental | Participants were administered obinutuzumab, Atezolizumab, and 20 mg of Lenalidomide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab (MPDL3280A) [TECENTRIQ] | Drug | Atezolizumab will be administered at a flat dose of 840 mg on Days 1 and 15 of Cycles 2 to 6, given in 28-day cycles as induction treatment and 840 mg on Days 1 and 2 of each month, given as maintenance treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria | Complete response (CR) was evaluated through use of PET-CT scans, using the Modified Lugano 2014 criteria. Response was determined by the IRC. | 6 months (up to clinical cut-off date (CCOD) of 23 October 2018) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving CR at EOI, as Determined by the Investigator Using Modified Lugano 2014 Criteria | CR was evaluated through use of PET-CT scans, using the Modified Lugano 2014 criteria. Response was determined by the Investigator. | 6 months (up to CCOD of 23 October 2018) |
| Percentage of Participants Achieving CR at EOI, as Determined by the IRC and Investigator Using Lugano 2014 Criteria |
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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 |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University Miami |
All participants received daily low-dose aspirin (81-100 mg) during lenalidomide treatment and until 28 days after the last dose of lenalidomide. Participants who are unable to tolerate aspirin, who have a history of thromboembolism (TE), and who are at high risk of TE, received warfarin or low-molecular-weight heparin (LMWH).
The study was conducted at 14 sites in France (9) and USA (5).
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| ID | Title | Description |
|---|---|---|
| FG000 | Atezolizumab-G-lena 15mg | Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide |
| FG001 | Atezolizumab-G-lena 20mg | Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide. |
| 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 | Oct 26, 2019 |
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| Lenalidomide | Drug | Lenalidomide will be administered orally once daily on Days 1 to 21 of Cycles 1 to 6 (28-day cycles) during induction treatment and on Days 1 to 21 of each month during maintenance treatment. Lenalidomide will be administered at a dose of 15 or 20 mg (dose may be de-escalated to 10 mg) during induction treatment and at 10 mg during maintenance treatment. During the expansion phase, lenalidomide will be administered at the RP2D during induction treatment and at 10 mg during maintenance treatment. |
|
| Obinutuzumab | Drug | Obinutuzumab will be administered by intravenous infusion at an absolute (flat) dose of 1000 mg on Days 1, 8, and 15 of the first cycle and on Day 1 of each subsequent cycle during induction treatment, and on Day 1 of every other month (i.e., every 2 months) during maintenance treatment. |
|
CR was evaluated through use of CT scans, using the Lugano 2014 criteria. Response was determined by the IRC and by the Investigator. |
| 6 months (up to CCOD of 23 October 2018) |
| Percentage of Participants With Objective Response (CR or PR) at EOI as Determined by the IRC and Investigator on the Basis of PET-CT Scans | Objective response was evaluated through use of PET-CT scans, using the Lugano 2014 or modified Lugano 2014 criteria. Response was determined by the IRC and by the Investigator. | 6 months (up to CCOD of 23 October 2018) |
| Percentage of Participants With Objective Response (CR or PR) at EOI as Determined by the IRC and Investigator on the Basis of CT Scans Alone | Objective response was evaluated through use of CT scans alone, using the Lugano 2014. Response was determined by the IRC and by the Investigator. | 6 months (up to CCOD of 23 October 2018) |
| Percentage of Participants With Best Response (CR or PR) During the Study as Determined by the Investigator on the Basis of CT Scans Alone | Best Response was evaluated through use of CT scans alone, using the Lugano 2014. Response was determined by the Investigator. | 30 months |
| Percentage of Participants With Adverse Events and Serious Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Baseline up to approximately 59 months |
| Number of Participants With Dose-limiting Toxicities (DLTs) During Cycle 2 of Study Treatment | Does limiting toxicity (DLT) is defined as any one of the following events occurring during Cycle 2 of treatment and assessed by the investigator as related to study treatment: - Adverse event of any grade that leads to a delay of more than 14 days at the start of the next treatment cycle; - Hematologic adverse events (neutropenia, thrombocytopenia); - Non-hematologic adverse event, except IRRs, diarrhea, nausea or vomiting | Day 1 - Day 28 of second cycle |
| Serum Concentration of Obinutuzumab (mcg/mL) | The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year | Baseline up to approximately 59 months |
| Serum Concentration of Atezolizumab (mcg/mL) | The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year | Baseline up to approximately 59 months |
| Serum Concentration of Lenalidomide (ng/mL) | The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; HR = Hour | Baseline up to approximately 59 months |
| Number of Participants Positive for Human Anti-human Antibodies (HAHA) to Obinutuzumab | The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year. All baseline and post-baseline samples from participants were negative for HAHAs to obinutuzumab and the results are shown below. | Baseline up to approximately 59 months |
| Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab | The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year. All baseline and post-baseline samples were negative for ATAs to atezolizumab and the results are shown below. | Baseline up to approximately 59 months |
| Miami |
| Florida |
| 33136 |
| United States |
| Norton Medical Plaza II | Louisville | Kentucky | 40207 | United States |
| Memorial Sloan-Kettering Cancer Center; Hematology/Oncology | New York | New York | 10065 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Chu Toulouse | Bron | 69500 | France |
| Hopital Henri Mondor; 51 Av Mal Lattre De Tassigny | Créteil | 94010 | France |
| Hopital du Bocage | Dijon | 21034 | France |
| Centre Jean Bernard | Le Mans | 72015 | France |
| Centre Hospitalier Le Mans | Le Mans | 72037 | France |
| CHRU de Lille - Hopital Claude Huriez | Lille | 59037 | France |
| CHU Montpellier - Saint ELOI | Montpellier | 34295 | France |
| CHU - Hôtel Dieu hematolgie clinique | Nantes | 44093 | France |
| Centre Hospitalier Lyon Sud; Hematolgie | Pierre-Bénite | 69495 | France |
| CHU de Rennes - Hopital de Pontchaillo | Rennes | 35033 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atezolizumab-G-lena 15mg | Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide |
| BG001 | Atezolizumab-G-lena 20mg | Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 Achieving Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria | Complete response (CR) was evaluated through use of PET-CT scans, using the Modified Lugano 2014 criteria. Response was determined by the IRC. | As no DLTs were observed, the dose of 20 mg lenalidomide was confirmed as the recommended Phase II dose (RP2D) for lenalidomide. Only participants who received lenalidomide induction at the 20 mg RP2D were included in the Efficacy Evaluable population, hence participants in the Atezo-G-L 15 mg arm were not included in the efficacy analysis. | Posted | Number | 90% Confidence Interval | Percentage of Participants | 6 months (up to clinical cut-off date (CCOD) of 23 October 2018) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving CR at EOI, as Determined by the Investigator Using Modified Lugano 2014 Criteria | CR was evaluated through use of PET-CT scans, using the Modified Lugano 2014 criteria. Response was determined by the Investigator. | As no DLTs were observed, the dose of 20 mg lenalidomide was confirmed as the recommended Phase II dose (RP2D) for lenalidomide. Only participants who received lenalidomide induction at the 20 mg RP2D were included in the Efficacy Evaluable population, hence participants in the Atezo-G-L 15 mg arm were not included in the efficacy analysis. | Posted | Number | 90% Confidence Interval | Percentage of Participants | 6 months (up to CCOD of 23 October 2018) |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving CR at EOI, as Determined by the IRC and Investigator Using Lugano 2014 Criteria | CR was evaluated through use of CT scans, using the Lugano 2014 criteria. Response was determined by the IRC and by the Investigator. | As no DLTs were observed, the dose of 20 mg lenalidomide was confirmed as the recommended Phase II dose (RP2D) for lenalidomide. Only participants who received lenalidomide induction at the 20 mg RP2D were included in the Efficacy Evaluable population, hence participants in the Atezo-G-L 15 mg arm were not included in the efficacy analysis. | Posted | Number | 90% Confidence Interval | Percentage of Participants | 6 months (up to CCOD of 23 October 2018) |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response (CR or PR) at EOI as Determined by the IRC and Investigator on the Basis of PET-CT Scans | Objective response was evaluated through use of PET-CT scans, using the Lugano 2014 or modified Lugano 2014 criteria. Response was determined by the IRC and by the Investigator. | As no DLTs were observed, the dose of 20 mg lenalidomide was confirmed as the recommended Phase II dose (RP2D) for lenalidomide. Only participants who received lenalidomide induction at the 20 mg RP2D were included in the Efficacy Evaluable population, hence participants in the Atezo-G-L 15 mg arm were not included in the efficacy analysis. | Posted | Number | 90% Confidence Interval | Percentage of Participants | 6 months (up to CCOD of 23 October 2018) |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response (CR or PR) at EOI as Determined by the IRC and Investigator on the Basis of CT Scans Alone | Objective response was evaluated through use of CT scans alone, using the Lugano 2014. Response was determined by the IRC and by the Investigator. | As no DLTs were observed, the dose of 20 mg lenalidomide was confirmed as the recommended Phase II dose (RP2D) for lenalidomide. Only participants who received lenalidomide induction at the 20 mg RP2D were included in the Efficacy Evaluable population, hence participants in the Atezo-G-L 15 mg arm were not included in the efficacy analysis. | Posted | Number | 90% Confidence Interval | Percentage of Participants | 6 months (up to CCOD of 23 October 2018) |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Best Response (CR or PR) During the Study as Determined by the Investigator on the Basis of CT Scans Alone | Best Response was evaluated through use of CT scans alone, using the Lugano 2014. Response was determined by the Investigator. | As no DLTs were observed, the dose of 20 mg lenalidomide was confirmed as the recommended Phase II dose (RP2D) for lenalidomide. Only participants who received lenalidomide induction at the 20 mg RP2D were included in the Efficacy Evaluable population, hence participants in the Atezo-G-L 15 mg arm were not included in the efficacy analysis. | Posted | Number | 90% Confidence Interval | Percentage | 30 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events and Serious Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | The Safety Evaluable Population included participants who received at least one dose of any study treatment. | Posted | Count of Participants | Participants | Baseline up to approximately 59 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Dose-limiting Toxicities (DLTs) During Cycle 2 of Study Treatment | Does limiting toxicity (DLT) is defined as any one of the following events occurring during Cycle 2 of treatment and assessed by the investigator as related to study treatment: - Adverse event of any grade that leads to a delay of more than 14 days at the start of the next treatment cycle; - Hematologic adverse events (neutropenia, thrombocytopenia); - Non-hematologic adverse event, except IRRs, diarrhea, nausea or vomiting | The Safety Evaluable Population included participants who received at least one dose of any study treatment. | Posted | Number | Number of Participants | Day 1 - Day 28 of second cycle |
|
| ||||||||||||||||||||||||||||||
| Secondary | Serum Concentration of Obinutuzumab (mcg/mL) | The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year | The Safety Evaluable Population included participants who received at least one dose of any study treatment. | Posted | Mean | Standard Deviation | mcg/mL | Baseline up to approximately 59 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Serum Concentration of Atezolizumab (mcg/mL) | The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year | The Safety Evaluable Population included participants who received at least one dose of any study treatment. | Posted | Mean | Standard Deviation | micrograms per milliliter (mcg/mL) | Baseline up to approximately 59 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Serum Concentration of Lenalidomide (ng/mL) | The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; HR = Hour | The Safety Evaluable Population included participants who received at least one dose of any study treatment. | Posted | Mean | Standard Deviation | nanograms/milliliter (ng/mL) | Baseline up to approximately 59 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Positive for Human Anti-human Antibodies (HAHA) to Obinutuzumab | The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year. All baseline and post-baseline samples from participants were negative for HAHAs to obinutuzumab and the results are shown below. | The Safety Evaluable Population included participants who received at least one dose of any study treatment. | Posted | Count of Participants | Participants | Baseline up to approximately 59 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab | The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year. All baseline and post-baseline samples were negative for ATAs to atezolizumab and the results are shown below. | The Safety Evaluable Population included participants who received at least one dose of any study treatment. | Posted | Count of Participants | Participants | Baseline up to approximately 59 months |
|
|
Baseline up to approximately 59 months
The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
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-G-lena 15mg | Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide | 1 | 4 | 2 | 4 | 4 | 4 |
| EG001 | Atezolizumab-G-lena 20mg | Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide. | 7 | 34 | 16 | 34 | 34 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ADMINISTRATION SITE EXTRAVASATION | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| EAR INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| EPIDIDYMITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| PNEUMONIA PARAINFLUENZAE VIRAL | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| MENINGIOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| TUMOUR FLARE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| ATYPICAL FIBROXANTHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| NEUROENDOCRINE CARCINOMA OF THE SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| SARCOMATOID CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPERTHYROIDISM | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
| |
| LACRIMATION INCREASED | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| AXILLARY PAIN | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PERIPHERAL SWELLING | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| XEROSIS | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HEPATOCELLULAR INJURY | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| BRONCHIOLITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| FUNGAL SKIN INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| TINEA INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| SKIN ABRASION | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| AMYLASE INCREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| LIPASE INCREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| FLUID OVERLOAD | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| GROIN PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| POST HERPETIC NEURALGIA | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
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| DRY EYE | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPOGAMMAGLOBULINAEMIA | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
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| ACUTE SINUSITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| HOT FLUSH | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
Enrollment for this study was stopped early as the Sponsor chose not to claim superiority over existing therapies.
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 |
| Sep 14, 2021 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000077269 | Lenalidomide |
| C543332 | obinutuzumab |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Not Stated |
|
| Unknown |
|
| White |
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