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| ID | Type | Description | Link |
|---|---|---|---|
| GO01297 | Other Identifier | Hoffmann-La Roche | |
| 2009-015504-25 | EudraCT Number |
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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin's lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years' safety follow-up from last dose).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bendamustine Alone | Active Comparator | Participants will receive bendamustine 120 milligrams per meter square (mg/m^2) Intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for up to six cycles. |
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| Obinutuzumab + Bendamustine | Experimental | Induction phase: Participants will receive bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants will also receive obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with complete response (CR), partial response (PR) or stable response (SD) then will receive obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurs first). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obinutuzumab | Drug | IV infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death | PD was assessed by an IRC according to the modified response criteria for indolent Non-Hodgkin's Lymphoma (iNHL) (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50 percent (%) increase from nadir in the sum of product diameter (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (example: splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of less than (<) 1.0 cm must increase by greater than or equal to (≥) 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node greater than (>) 1 cm in its short axis. | Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cycle [Cy] 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall]) |
| Progression-Free Survival (PFS) as Assessed by IRC | PFS was defined as the time from randomization to the first occurrence of PD or death as assessed by an IRC according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley. | Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall]) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With PD or Death as Assessed by Investigator | PD was assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Cancer Center, PC | Mobile | Alabama | 36608 | United States | ||
| Dr. Donald W. Hill, MD, FACP |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31462735 | Derived | Pott C, Sehn LH, Belada D, Gribben J, Hoster E, Kahl B, Kehden B, Nicolas-Virelizier E, Spielewoy N, Fingerle-Rowson G, Harbron C, Mundt K, Wassner-Fritsch E, Cheson BD. MRD response in relapsed/refractory FL after obinutuzumab plus bendamustine or bendamustine alone in the GADOLIN trial. Leukemia. 2020 Feb;34(2):522-532. doi: 10.1038/s41375-019-0559-9. Epub 2019 Aug 28. | |
| 31050355 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bendamustine Alone | Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles. |
| FG001 | Obinutuzumab + Bendamustine | Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Bendamustine | Drug | IV infusion. |
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| Baseline until PD or death, whichever occurred first (up to 8.5 years overall)) |
| PFS as Assessed by Investigator | PFS was defined as the time from randomization to the first occurrence of PD as assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007), or death from any cause on study. PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. | Baseline until PD or death, whichever occurred first (up to 8.5 years overall) |
| Percentage of Participants With Objective Response as Assessed by IRC | Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. IRC review was performed up clinical cutoff date of to 1 May 2015. | Baseline until PD or death, whichever occurred first (up to approximately 5 years) |
| Percentage of Participants With Objective Response as Assessed by Investigator | Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. | Baseline until PD or death, whichever occurred first (up to approximately 8.5 years) |
| Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC | BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease & disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan & no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic & hepatic nodules, involvement of other organs is usually assessable & no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions (e.g., splenic or hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015. | Baseline until PD or death, whichever occurred first (up to approximately 5 years) |
| Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator | BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain the criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). | Baseline until PD or death, whichever occurred first (up to approximately 8.5 years) |
| Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC | BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease & disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan & no new sites; no increase in size of other nodes, liver or spleen; with exception of splenic & hepatic nodules, involvement of other organs is usually assessable & no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or size of other lesions (e.g., splenic/hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015. | Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1) |
| Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator | BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). | Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1) |
| Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by IRC | Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. IRC review was performed up clinical cutoff date of to 1 May 2015. | Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1) |
| Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by Investigator | Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. | Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1) |
| Duration of Response (DoR) as Assessed by IRC | DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable evidence of disease & disease-related symptoms if present before therapy; liver, spleen returned to normal size; if bone marrow involved by lymphoma before treatment, infiltrate must be cleared on repeat bone marrow biopsy. PR: at least 50% measurable disease regressed vs. to baseline scan and no new sites; no increase in size of other nodes/liver/spleen, exception: splenic, hepatic nodules; other organs involved is usually assessable; no measurable disease present. PD: any new lesion >1.5 cm in any axis appear during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR estimated using Kaplan-Meier method. IRC review performed up to clinical cutoff date 1 May 2015. | Baseline until PD or death, whichever occurred first (up to approximately 5 years) |
| Duration of Response (DoR) as Assessed by Investigator | DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy; liver, spleen returned to normal size (if enlarged at baseline); if bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic, hepatic nodules; involvement of other organs is usually assessable; no presence of measurable disease. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR was estimated using Kaplan-Meier method. | Baseline until PD or death, whichever occurred first (up to approximately 8.5 years) |
| Disease-Free Survival (DFS) in Participants With CR as Assessed by IRC | DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method. IRC review was performed up clinical cutoff date of to 1 May 2015. | Baseline until PD or death, whichever occurred first (up to approximately 5 years) |
| Disease-Free Survival (DFS) in Participants With CR as Assessed by Investigator | DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method. | Baseline until PD or death, whichever occurred first (up to approximately 8.5 years) |
| Event-free Survival (EFS) as Assessed by IRC | EFS was defined as the time between the date of randomization and the date of PD/relapse based on IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]), death from any cause on study, or start of a new anti-lymphoma therapy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. EFS was estimated using Kaplan-Meier method. IRC review was performed up clinical cutoff date of to 1 May 2015. | Baseline until PD or death, whichever occurred first (up to approximately 5 years) |
| Percentage of Participants Who Died | Baseline until death (up to 8.5 years overall) |
| Overall Survival (OS) | OS was defined as the time between the date of randomization and the date of death from any cause. OS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. | Baseline until death (up to 8.5 years overall) |
| Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Physical Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for physical well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better participant-reported outcome (PRO)/quality of life (QoL). In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 |
| CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Social/family Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for social/family well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 |
| CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Emotional Well-being sub-scale includes 6 items measured on 0-4 point scale. The total score for emotional well-being sub-scale is sum of each 6 items (range: 0-24). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 |
| CFB in FACT-Lym-Functional Well-Being Sub-scale Score | The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Functional Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for functional well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 |
| CFB in FACT-Lym-Lymphoma Sub-scale Score | The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Lymphoma scale includes 15 items measured on 0-4 point scale. The total score for lymphoma sub-scale is sum of each 15 items (range: 0-60). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 |
| CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under "CFB at Follow-up Month 2" and "CFB at Follow-up Month 4" categories. | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14 |
| CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase. | Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final follow-up (up to 2 years after end of induction) (End of induction = up to Month 6) |
| CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under "CFB at Follow-up Month 2" and "CFB at Follow-up Month 4" categories. | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14 |
| CFB in EQ-5D VAS Score During Maintenance Phase | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase. | Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction) (end of induction = up to Month 6) |
| CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | The FACT-G is the sum of 4 sub-scales (physical, social, emotional and functional well-being) of FACT-Lym which includes total 27 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-108. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 |
| CFB in FACT-Lym Trial Outcome Index (TOI) | TOI is the sum of 3 sub-scales (physical well-being, functional well-being, and Lymphoma sub-scale) of FACT-Lym which includes total 29 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 |
| CFB in FACT-Lym Total Score | FACT-Lym total score is the sum of physical well-being score (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and Lymphoma sub-scale (15 items); responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 |
| Time to Deterioration of FACT-Lym TOI | The median time, in month, from date of randomization until a clinically meaningful decline from baseline in TOI or death, whichever occurred first. TOI: sum of physical well-being score,functional well-being score, and Lymphoma sub-scale of FACT-Lym; total 29 items, responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from baseline. Time to deterioration was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. In timeframe, follow-up months represents months after end of induction (EOI) (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). | Baseline up to approximately 8.5 years |
| Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FACT-Lym: 42-items in 5 subscales. Responses to each item range from 0 (Not at all) to 4 (Very much). FACT-Lym Lymphoma subscale includes 15 items (total score range = 0-60). FACT-Lym TOI is sum of 3 subscales (physical well-being, functional well-being, lymphoma subscale) and includes 29 items (total score range = 0-116). FACT-Lym total score is sum of 42 items (total score ranges from 0-168). For all above, higher scores indicate a better PRO/QoL. DI from baseline: at least 3 point increase from baseline in FACT-Lym Lymphoma subscale; at least 6 point increase from baseline in FACT Lym TOI; at least 7 point increase from baseline in FACT Lym total scores. In timeframe, follow-up months represents months after EOI (e.g. Follow-up Month 2 is 2 months after EOI; EOI = up to Month 6). | Baseline, Cycle 5 Day 1 (C5D1) (Cycle length = 28 days), Follow-up Months 6 (FUM6), 12 (FUM12), 18 (FUM18), 24 (FUM24), Extension Follow Up Month 6 (Extension FUM6) |
| Casa Grande |
| Arizona |
| 85122 |
| United States |
| Highlands Oncology Group | Rogers | Arkansas | 72758 | United States |
| Kaiser Permanente - Bellflower | Bellflower | California | 90706 | United States |
| Bay Area Cancer Research Group, LLC | Pleasant Hill | California | 94523 | United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| Georgetown University Medical Center Lombardi Cancer Center | Washington D.C. | District of Columbia | 20007 | United States |
| Washington DC VA Med Center; Hematology | Washington D.C. | District of Columbia | 20422 | United States |
| University of Florida | Gainesville | Florida | 32607 | United States |
| University of Florida; Division of Hematology/Oncology | Gainesville | Florida | 33610-0277 | United States |
| Md Anderson Cancer Center Orlando | Orlando | Florida | 32806 | United States |
| Rush Cancer Institute | Chicago | Illinois | 60612 | United States |
| Quincy Medical Group | Quincy | Illinois | 62301 | United States |
| Simmons Cancer Institute | Springfield | Illinois | 62794-9677 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Univ Louisville School of Med | Louisville | Kentucky | 40202 | United States |
| New England Cancer Specialists | Scarborough | Maine | 04074 | United States |
| Meritus Center for Clinical Research | Hagerstown | Maryland | 21740 | United States |
| Capitol Comprehensive CA Care | Jefferson City | Missouri | 65101 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Hematology Oncology Assoc SJ | Mount Holly | New Jersey | 08060 | United States |
| San Juan Oncology | Farmington | New Mexico | 87401 | United States |
| The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc. | Columbus | Ohio | 43219 | United States |
| OHSU Knight Cancer Institute | Portland | Oregon | 97210 | United States |
| Pacific Oncology, PC | Portland | Oregon | 97210 | United States |
| OHSU Ctr for Health & Healing | Portland | Oregon | 97239 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| Sanford Health System | Sioux Falls | South Dakota | 57105 | United States |
| South Texas Inst of Cancer | Corpus Christi | Texas | 78405 | United States |
| University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| Univ of Wisconsin Hosp & Clin | Madison | Wisconsin | 53792 | United States |
| Lkh-Univ. Klinikum Graz | Graz | 8036 | Austria |
| Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt. | Salzburg | 5020 | Austria |
| Medizinische Universität Wien | Vienna | 1090 | Austria |
| ZNA Stuivenberg | Antwerp | 2060 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| CHU Ambroise Paré | Mons | 7000 | Belgium |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| British Columbia Cancer Agency | Kelowna | British Columbia | V1Y 5L3 | Canada |
| British Columbia Cancer Agency | Vancouver | British Columbia | V5Z 1H6 | Canada |
| Manitoba Cancer Care | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Moncton Hospital | Moncton | New Brunswick | E1C 6Z8 | Canada |
| Toronto East General Hospital; Main Pharmacy G Wing Basement | East York | Ontario | M4C 3E7 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M4X 1K9 | Canada |
| CHUM-Hosp Notre Dame | Montreal | Quebec | H2X 3E4 | Canada |
| McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology | Montreal | Quebec | H3T 1E2 | Canada |
| CHA Hopital de I enfant-Jesus | Québec | Quebec | G1J 1Z4 | Canada |
| Allan Blair Cancer Centre | Regina | Saskatchewan | S4T 7T1 | Canada |
| Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika | Brno | 625 00 | Czechia |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| I Interni klinika; Vseobecna fakultni nemocnice | Prague | 128 08 | Czechia |
| Institut Bergonie; Hematologie Oncologie | Bordeaux | 33076 | France |
| Polyclinique Bordeaux Nord | Bordeaux | 33300 | France |
| Hopital Henri Mondor | Créteil | 94010 | France |
| CH Dijon | Dijon | 21079 | France |
| Centre d'oncologie-radiotherap | LeMans | 72015 | France |
| Hopital Claude Huriez | Lille | 59037 | France |
| Centre Leon Berard | Lyon | 69008 | France |
| Hopital Bon Secour | Metz | 57038 | France |
| CHU Hopital Saint Eloi | Montpellier | 34295 | France |
| Hopital Hotel Dieu Et Hme; Clinique Dermatologique | Nantes | 44093 | France |
| Hopital Necker | Paris | 75015 | France |
| Hopital Saint Louis; Dermatologie 1 | Paris | 75475 | France |
| CHU Bordeaux | Pessac | 33604 | France |
| Centre Hospitalier Lyon Sud; Hematolgie | Pierre-Bénite | 69495 | France |
| Chu De Poitiers; Chu La Miletrie | Poitiers | 86021 | France |
| CHU de Reims | Reims | 51100 | France |
| Hopital Pontchaillou | Rennes | 35033 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Clinique Ste Anne | Strasbourg | 67000 | France |
| CHRU de; Maladies, Vasculaires | Vandœuvre-lès-Nancy | 54511 | France |
| St. Johannes Hospital Duisburg | Duisburg | 47166 | Germany |
| Klinikum Frankfurt Höchst | Frankfurt am Main | 65929 | Germany |
| Asklepios Klinik St. Georg | Hamburg | 20099 | Germany |
| Universitaetsklinikum Leipzig | Leipzig | 04103 | Germany |
| Klinikum der Universitat Munchen, Campus Grobhadern;; Medizinische Klinik und Poliklinik III | München | 81377 | Germany |
| Schwarzwald-Baar Klinikum GmbH | Villingen-Schwenningen | 78052 | Germany |
| Ospedale Vito Fazzi | Lecce | Apulia | 73100 | Italy |
| Azienda Ospedaliera Universitaria di Modena | Modena | Emilia-Romagna | 41100 | Italy |
| Azienda Ospedaliera Univ, Ematologica | Udine | Friuli Venezia Giulia | 33100 | Italy |
| Azienda Ospedaliera Univ | Rome | Lazio | 00133 | Italy |
| Universita La Sapienza | Rome | Lazio | 00161 | Italy |
| Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2 | Milan | Lombardy | 20133 | Italy |
| Irccs Policlinico San Matteo; Divisione Di Ematologia | Pavia | Lombardy | 27100 | Italy |
| Azienda Ospedale San Giovanni | Turin | Piedmont | 10126 | Italy |
| Ospedale Mauriziano Umberto I | Turin | Piedmont | 10128 | Italy |
| Azienda Ospedaliero Univ | Catania | Sicily | 95124 | Italy |
| Azienda Ospedaliera Univ | Florence | Tuscany | 50141 | Italy |
| VU MEDISCH CENTRUM; Dept. of Medical Oncology | Amsterdam | 1081 HV | Netherlands |
| Albert Schweitzer Ziekenhuis | Dordrecht | 3371 NM | Netherlands |
| Universitair Medisch Centrum Groningen | Groningen | 9713 GZ | Netherlands |
| Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology | Rotterdam | 3015 CE | Netherlands |
| Erasmus MC | Rotterdam | 3015 GD | Netherlands |
| Haga Ziekenhuis | The Hague | 2504 LN | Netherlands |
| Regional Oncology Hospital | Irkutsk | 664035 | Russia |
| Blokhin Cancer Research Center; Combined Treatment | Moscow | 115478 | Russia |
| City Clin Hosp n.a. S.P.Botkin | Moscow | 125101 | Russia |
| Russian Hema Res Ctr of RAMS | Moscow | 125167 | Russia |
| Republican Clinical Hospital n.a. Baranov; Haematology | Petrozavodsk | 185019 | Russia |
| Ryazan Regional Clinical Hosp | Ryazan | 390039 | Russia |
| SRI of Hematology and Transfusiology | Saint Petersburg | 191024 | Russia |
| St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta | Saint Petersburg | 197022 | Russia |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Univ. Nuestra Señora de Valme; | Sevillac | Sevilla | 41014 | Spain |
| Hospital Universitario Basurto | Bilbao | Vizcaya | 48013 | Spain |
| Hospital Universitario de la Princesa; Servicio de Hematologia | Madrid | 28006 | Spain |
| Hospital Universitario La Paz | Madrid | 28034 | Spain |
| Skånes University Hospital, Skånes Department of Onclology | Lund | 22185 | Sweden |
| Hematology Center; Karolinska Univ Hosp | Stockholm | 14186 | Sweden |
| Norrlands Uni Hospital; Onkologi Avd. | Umeå | 901 85 | Sweden |
| Onc Clin, Akademiska Sjukhuset | Uppsala | 751 85 | Sweden |
| Universitaetsspital Basel; Onkologie | Basel | 4031 | Switzerland |
| Inselspital Bern; Universitätsklinik für medizinische Onkologie | Bern | 3010 | Switzerland |
| Kantonsspital Graubünden;Onkologie und Hämatologie | Chur | 7000 | Switzerland |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| Barts & London School of Med; Medical Oncology | London | EC1A 7BE | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Singleton Hospital; Pharmacy Department | Swansea | SA2 8QA | United Kingdom |
| Derived |
| Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12. |
| 29584548 | Derived | Cheson BD, Chua N, Mayer J, Dueck G, Trneny M, Bouabdallah K, Fowler N, Delwail V, Press O, Salles G, Gribben JG, Lennard A, Lugtenburg PJ, Fingerle-Rowson G, Mattiello F, Knapp A, Sehn LH. Overall Survival Benefit in Patients With Rituximab-Refractory Indolent Non-Hodgkin Lymphoma Who Received Obinutuzumab Plus Bendamustine Induction and Obinutuzumab Maintenance in the GADOLIN Study. J Clin Oncol. 2018 Aug 1;36(22):2259-2266. doi: 10.1200/JCO.2017.76.3656. Epub 2018 Mar 27. |
| 27345636 | Derived | Sehn LH, Chua N, Mayer J, Dueck G, Trneny M, Bouabdallah K, Fowler N, Delwail V, Press O, Salles G, Gribben J, Lennard A, Lugtenburg PJ, Dimier N, Wassner-Fritsch E, Fingerle-Rowson G, Cheson BD. Obinutuzumab plus bendamustine versus bendamustine monotherapy in patients with rituximab-refractory indolent non-Hodgkin lymphoma (GADOLIN): a randomised, controlled, open-label, multicentre, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1081-1093. doi: 10.1016/S1470-2045(16)30097-3. Epub 2016 Jun 23. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bendamustine Alone | Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles. |
| BG001 | Obinutuzumab + Bendamustine | Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| 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 | |||||||||||||||||||||||
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| Primary | Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death | PD was assessed by an IRC according to the modified response criteria for indolent Non-Hodgkin's Lymphoma (iNHL) (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50 percent (%) increase from nadir in the sum of product diameter (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (example: splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of less than (<) 1.0 cm must increase by greater than or equal to (≥) 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node greater than (>) 1 cm in its short axis. | ITT population. | Posted | Number | participants | Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cycle [Cy] 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall]) |
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| Primary | Progression-Free Survival (PFS) as Assessed by IRC | PFS was defined as the time from randomization to the first occurrence of PD or death as assessed by an IRC according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley. | ITT population. | Posted | Median | 95% Confidence Interval | months | Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall]) |
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| Secondary | Number of Participants With PD or Death as Assessed by Investigator | PD was assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. | ITT population. | Posted | Number | participants | Baseline until PD or death, whichever occurred first (up to 8.5 years overall)) |
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| Secondary | PFS as Assessed by Investigator | PFS was defined as the time from randomization to the first occurrence of PD as assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007), or death from any cause on study. PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. | ITT population. | Posted | Median | 95% Confidence Interval | months | Baseline until PD or death, whichever occurred first (up to 8.5 years overall) |
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| Secondary | Percentage of Participants With Objective Response as Assessed by IRC | Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. IRC review was performed up clinical cutoff date of to 1 May 2015. | ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until PD or death, whichever occurred first (up to approximately 5 years) |
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| Secondary | Percentage of Participants With Objective Response as Assessed by Investigator | Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. | ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until PD or death, whichever occurred first (up to approximately 8.5 years) |
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| Secondary | Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC | BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease & disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan & no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic & hepatic nodules, involvement of other organs is usually assessable & no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions (e.g., splenic or hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015. | ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until PD or death, whichever occurred first (up to approximately 5 years) |
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| Secondary | Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator | BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain the criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). | ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until PD or death, whichever occurred first (up to approximately 8.5 years) |
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| Secondary | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC | BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease & disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan & no new sites; no increase in size of other nodes, liver or spleen; with exception of splenic & hepatic nodules, involvement of other organs is usually assessable & no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or size of other lesions (e.g., splenic/hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015. | ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1) |
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| Secondary | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator | BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). | ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1) |
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| Secondary | Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by IRC | Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. IRC review was performed up clinical cutoff date of to 1 May 2015. | ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1) |
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| Secondary | Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by Investigator | Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. | ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1) |
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| Secondary | Duration of Response (DoR) as Assessed by IRC | DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable evidence of disease & disease-related symptoms if present before therapy; liver, spleen returned to normal size; if bone marrow involved by lymphoma before treatment, infiltrate must be cleared on repeat bone marrow biopsy. PR: at least 50% measurable disease regressed vs. to baseline scan and no new sites; no increase in size of other nodes/liver/spleen, exception: splenic, hepatic nodules; other organs involved is usually assessable; no measurable disease present. PD: any new lesion >1.5 cm in any axis appear during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR estimated using Kaplan-Meier method. IRC review performed up to clinical cutoff date 1 May 2015. | ITT population. Here, number of participants analyzed signified those participants who had objective response at any time during the study. | Posted | Median | 95% Confidence Interval | months | Baseline until PD or death, whichever occurred first (up to approximately 5 years) |
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| Secondary | Duration of Response (DoR) as Assessed by Investigator | DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy; liver, spleen returned to normal size (if enlarged at baseline); if bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic, hepatic nodules; involvement of other organs is usually assessable; no presence of measurable disease. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR was estimated using Kaplan-Meier method. | ITT population. Here, number of participants analyzed signified those participants who had objective response at any time during the study. | Posted | Median | 95% Confidence Interval | months | Baseline until PD or death, whichever occurred first (up to approximately 8.5 years) |
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| Secondary | Disease-Free Survival (DFS) in Participants With CR as Assessed by IRC | DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method. IRC review was performed up clinical cutoff date of to 1 May 2015. | ITT population. Here, number of participants analyzed signified those participants who had an objective response of CR. | Posted | Median | 95% Confidence Interval | months | Baseline until PD or death, whichever occurred first (up to approximately 5 years) |
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| Secondary | Disease-Free Survival (DFS) in Participants With CR as Assessed by Investigator | DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method. | ITT population. Here, number of participants analyzed signified those participants who had an objective response of CR. | Posted | Median | 95% Confidence Interval | months | Baseline until PD or death, whichever occurred first (up to approximately 8.5 years) |
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| Secondary | Event-free Survival (EFS) as Assessed by IRC | EFS was defined as the time between the date of randomization and the date of PD/relapse based on IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]), death from any cause on study, or start of a new anti-lymphoma therapy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. EFS was estimated using Kaplan-Meier method. IRC review was performed up clinical cutoff date of to 1 May 2015. | ITT population. | Posted | Median | 95% Confidence Interval | months | Baseline until PD or death, whichever occurred first (up to approximately 5 years) |
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| Secondary | Percentage of Participants Who Died | ITT population. | Posted | Number | percentage of participants | Baseline until death (up to 8.5 years overall) |
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| Secondary | Overall Survival (OS) | OS was defined as the time between the date of randomization and the date of death from any cause. OS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. | ITT population. | Posted | Median | 95% Confidence Interval | months | Baseline until death (up to 8.5 years overall) |
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| Secondary | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Physical Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for physical well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better participant-reported outcome (PRO)/quality of life (QoL). In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). | ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 |
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| Secondary | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Social/family Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for social/family well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). | ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 |
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| Secondary | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Emotional Well-being sub-scale includes 6 items measured on 0-4 point scale. The total score for emotional well-being sub-scale is sum of each 6 items (range: 0-24). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). | ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 |
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| Secondary | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Functional Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for functional well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). | ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 |
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| Secondary | CFB in FACT-Lym-Lymphoma Sub-scale Score | The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Lymphoma scale includes 15 items measured on 0-4 point scale. The total score for lymphoma sub-scale is sum of each 15 items (range: 0-60). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). | ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 |
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| Secondary | CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under "CFB at Follow-up Month 2" and "CFB at Follow-up Month 4" categories. | ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14 |
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| Secondary | CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase. | ITT population (Obinutuzumab + Bendamustine arm only). Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final follow-up (up to 2 years after end of induction) (End of induction = up to Month 6) |
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| Secondary | CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under "CFB at Follow-up Month 2" and "CFB at Follow-up Month 4" categories. | ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14 |
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| Secondary | CFB in EQ-5D VAS Score During Maintenance Phase | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase. | ITT population (Obinutuzumab + Bendamustine arm only). Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction) (end of induction = up to Month 6) |
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| Secondary | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | The FACT-G is the sum of 4 sub-scales (physical, social, emotional and functional well-being) of FACT-Lym which includes total 27 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-108. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). | ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 |
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| Secondary | CFB in FACT-Lym Trial Outcome Index (TOI) | TOI is the sum of 3 sub-scales (physical well-being, functional well-being, and Lymphoma sub-scale) of FACT-Lym which includes total 29 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). | ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 |
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| Secondary | CFB in FACT-Lym Total Score | FACT-Lym total score is the sum of physical well-being score (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and Lymphoma sub-scale (15 items); responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). | ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 |
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| Secondary | Time to Deterioration of FACT-Lym TOI | The median time, in month, from date of randomization until a clinically meaningful decline from baseline in TOI or death, whichever occurred first. TOI: sum of physical well-being score,functional well-being score, and Lymphoma sub-scale of FACT-Lym; total 29 items, responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from baseline. Time to deterioration was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. In timeframe, follow-up months represents months after end of induction (EOI) (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). | ITT population. | Posted | Median | 95% Confidence Interval | Months | Baseline up to approximately 8.5 years |
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| Secondary | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FACT-Lym: 42-items in 5 subscales. Responses to each item range from 0 (Not at all) to 4 (Very much). FACT-Lym Lymphoma subscale includes 15 items (total score range = 0-60). FACT-Lym TOI is sum of 3 subscales (physical well-being, functional well-being, lymphoma subscale) and includes 29 items (total score range = 0-116). FACT-Lym total score is sum of 42 items (total score ranges from 0-168). For all above, higher scores indicate a better PRO/QoL. DI from baseline: at least 3 point increase from baseline in FACT-Lym Lymphoma subscale; at least 6 point increase from baseline in FACT Lym TOI; at least 7 point increase from baseline in FACT Lym total scores. In timeframe, follow-up months represents months after EOI (e.g. Follow-up Month 2 is 2 months after EOI; EOI = up to Month 6). | ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome. | Posted | Number | Percentage of participants | Baseline, Cycle 5 Day 1 (C5D1) (Cycle length = 28 days), Follow-up Months 6 (FUM6), 12 (FUM12), 18 (FUM18), 24 (FUM24), Extension Follow Up Month 6 (Extension FUM6) |
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Baseline up to 8.5 years
Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
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 | Bendamustine Alone | Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles. | 76 | 203 | 194 | 203 | ||
| EG001 | Obinutuzumab + Bendamustine | Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first). | 91 | 204 | 200 | 204 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AGRANULOCYTOSIS | Blood and lymphatic system disorders | MedDRA v21.1 | Systematic Assessment |
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| ANAEMIA | Blood and lymphatic system disorders | MedDRA v21.1 | Systematic Assessment |
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| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA v21.1 | Systematic Assessment |
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| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA v21.1 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA v21.1 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA v21.1 | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA v21.1 | Systematic Assessment |
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| ATRIAL FLUTTER | Cardiac disorders | MedDRA v21.1 | Systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA v21.1 | Systematic Assessment |
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| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA v21.1 | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA v21.1 | Systematic Assessment |
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| PAROXYSMAL ARRHYTHMIA | Cardiac disorders | MedDRA v21.1 | Systematic Assessment |
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| HYDROCELE | Congenital, familial and genetic disorders | MedDRA v21.1 | Systematic Assessment |
| |
| NECROTISING RETINITIS | Eye disorders | MedDRA v21.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| ANAL FISSURE | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| FOOD POISONING | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| LARGE INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| MELAENA | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| CATHETER SITE PAIN | General disorders | MedDRA v21.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA v21.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA v21.1 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA v21.1 | Systematic Assessment |
| |
| HYPERTHERMIA | General disorders | MedDRA v21.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA v21.1 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA v21.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA v21.1 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA v21.1 | Systematic Assessment |
| |
| GRAFT VERSUS HOST DISEASE | Immune system disorders | MedDRA v21.1 | Systematic Assessment |
| |
| ATYPICAL PNEUMONIA | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| CAMPYLOBACTER INFECTION | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| COXSACKIE MYOCARDITIS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| DEVICE RELATED SEPSIS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| ENCEPHALITIS VIRAL | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| ENDOCARDITIS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| ESCHERICHIA SEPSIS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| FUNGAL SEPSIS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| GASTROENTERITIS NOROVIRUS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| HEPATITIS B REACTIVATION | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| LUNG INFECTION PSEUDOMONAL | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| PNEUMONIA CYTOMEGALOVIRAL | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| PSEUDOMONAL SEPSIS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| PSEUDOMONAS BRONCHITIS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| RESPIRATORY SYNCYTIAL VIRUS INFECTION | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| TOOTH INFECTION | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| VASCULAR DEVICE INFECTION | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA v21.1 | Systematic Assessment |
| |
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA v21.1 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA v21.1 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA v21.1 | Systematic Assessment |
| |
| JAW FRACTURE | Injury, poisoning and procedural complications | MedDRA v21.1 | Systematic Assessment |
| |
| POST PROCEDURAL BILE LEAK | Injury, poisoning and procedural complications | MedDRA v21.1 | Systematic Assessment |
| |
| SEROMA | Injury, poisoning and procedural complications | MedDRA v21.1 | Systematic Assessment |
| |
| STAB WOUND | Injury, poisoning and procedural complications | MedDRA v21.1 | Systematic Assessment |
| |
| VASCULAR PSEUDOANEURYSM | Injury, poisoning and procedural complications | MedDRA v21.1 | Systematic Assessment |
| |
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA v21.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA v21.1 | Systematic Assessment |
| |
| BORRELIA TEST | Investigations | MedDRA v21.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA v21.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA v21.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA v21.1 | Systematic Assessment |
| |
| TUMOUR LYSIS SYNDROME | Metabolism and nutrition disorders | MedDRA v21.1 | Systematic Assessment |
| |
| MUSCLE HAEMORRHAGE | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Systematic Assessment |
| |
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| ADENOCARCINOMA GASTRIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| BRONCHIAL NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| CHOLANGIOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| COLORECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| INTESTINAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| LEIOMYOSARCOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| MYELODYSPLASTIC SYNDROME | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| POLYCYTHAEMIA VERA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| RENAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| T-CELL LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| THYROID NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Systematic Assessment |
| |
| AMYOTROPHIC LATERAL SCLEROSIS | Nervous system disorders | MedDRA v21.1 | Systematic Assessment |
| |
| CENTRAL NERVOUS SYSTEM LESION | Nervous system disorders | MedDRA v21.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA v21.1 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA v21.1 | Systematic Assessment |
| |
| POST HERPETIC NEURALGIA | Nervous system disorders | MedDRA v21.1 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA v21.1 | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA v21.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA v21.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA v21.1 | Systematic Assessment |
| |
| MANIA | Psychiatric disorders | MedDRA v21.1 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA v21.1 | Systematic Assessment |
| |
| END STAGE RENAL DISEASE | Renal and urinary disorders | MedDRA v21.1 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA v21.1 | Systematic Assessment |
| |
| POLLAKIURIA | Renal and urinary disorders | MedDRA v21.1 | Systematic Assessment |
| |
| URETERIC OBSTRUCTION | Renal and urinary disorders | MedDRA v21.1 | Systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA v21.1 | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA v21.1 | Systematic Assessment |
| |
| BRONCHOSPASM | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| CHYLOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| EMPHYSEMA | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| PARANEOPLASTIC PEMPHIGUS | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Systematic Assessment |
| |
| SOCIAL PROBLEM | Social circumstances | MedDRA v21.1 | Systematic Assessment |
| |
| CIRCULATORY COLLAPSE | Vascular disorders | MedDRA v21.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA v21.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA v21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA v21.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA v21.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA v21.1 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA v21.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA v21.1 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA v21.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA v21.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA v21.1 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA v21.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA v21.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA v21.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA v21.1 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA v21.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA v21.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA v21.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA v21.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA v21.1 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA v21.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA v21.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA v21.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA v21.1 | Systematic Assessment |
| |
| PHLEBITIS | Vascular disorders | MedDRA v21.1 | 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 | Genentech | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| 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 |
|---|---|
| C543332 | obinutuzumab |
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Not Stated |
|
| Asian |
|
| Black or African American |
|
| Multiple |
|
| Unknown |
|
| White |
|
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first). |
|
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|
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first). |
|
|
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first). |
|
|
| OG001 |
| Obinutuzumab + Bendamustine |
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first). |
|
|
| OG001 |
| Obinutuzumab + Bendamustine |
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first). |
|
|
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first). |
|
|
|
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
|
|
|
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
|
|
|
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first). |
|
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Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
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| Participants |
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Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first). |
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| OG001 |
| Obinutuzumab + Bendamustine |
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first). |
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| Obinutuzumab + Bendamustine |
Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first). |
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