Non-Hodgkin's Lymphoma
Conditions
Brief summary
This is a open-label, multicenter, non-randomized, study to evaluate the safety, efficacy, and pharmacokinetics of idasanutlin in combination with obinutuzumab in participants with R/R FL and rituximab in combination with idasanutlin in R/R DLBCL. The study will include an initial dose-escalation phase followed by an expansion phase. The dose-escalation phase is designed to determine the recommended phase 2 dose (RP2D) for idasanutlin in combination with obinutuzumab for FL and in combination with rituximab for DLBCL. The expansion phase is designed to further assess the safety and efficacy of obinutuzumab in combination with idasanutlin at the RP2D with the selected regimen in participants with R/R FL and of rituximab in combination with idasanutlin at the RP2D in participants with R/R DLBCL.
Interventions
DRUGIdasanutlin
Participants received idasanutlin film-coated tablets orally at a starting dose of 100 mg daily on Days 1 to 5 of each 28-day cycle. Escalation was to occur in at least 50-mg increments, and daily doses greater than or equal to (≥) 400 mg will be split into twice daily dosing.
DRUGObinutuzumab
Participants received a fixed dose of obinutuzumab 1000 mg intravenous (IV) infusion to be given on Days 1, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 (1 cycle = 28 days). For eligible participants with FL, post-induction treatment was to be given at a dose of 1000 mg via IV infusion on Day 1 once every 2 months for a maximum of up to 24 months.
DRUGRituximab
Participants received a fixed dose of rituximab, 375 mg/m\^2 IV infusion on Day 1 of Cycles 1-6. Post-induction treatment for eligible participants was to be given at a dose of 375 mg/m\^2 IV infusion on Day 1 of every other month for up to 6 months, until disease progression or unacceptable toxicity.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * Histologically documented cluster of differentiation (CD) 20-positive B-cell lymphoma classified as relapsed or refractory FL or DLBCL after treatment with at least two prior chemoimmunotherapy regimens that included an anti-CD20 monoclonal antibody (mAb) and for which no other more appropriate treatment option exists * At least one bidimensionally measurable lesion * Agreement to remain abstinent or use adequate contraception, among women or men of childbearing potential
Exclusion criteria
* Known CD20-negative status at relapse or progression * Prior allogeneic stem cell transplantation (SCT), or autologous SCT within 100 days prior to Day 1 of Cycle 1 * Current use of systemic corticosteroids greater than (\>) 20 mg prednisone per day (or equivalent), or prior anti-cancer therapy to include: radioimmunoconjugate within 12 weeks; mAb or antibody-drug conjugate within 4 weeks; or radiotherapy/chemotherapy/hormone therapy/targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1 * Requirement for chronic anticoagulation * Central nervous system (CNS) disease * Active infection * Positive for human immunodeficiency virus (HIV) or hepatitis B or C * Receipt of a live virus vaccine within 28 days prior to Day 1 of Cycle 1 * Poor hematologic, renal, or hepatic function * Pregnant or lactating women * History of progressive multifocal leukoencephalopathy (PML)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Complete Response at the End of Induction, Determined by an Independent Review Committee (IRC) on the Basis of Positron Emission Tomography and Computed Tomography (PET-CT) Scans Using Modified Lugano 2014 Criteria | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days) | The plan was for the IRC to evaluate responses at the end of induction treatment in participants from the expansion phase using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based complete response (CR), which required a complete metabolic response with a score of 1, 2, or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to \[≤\] mediastinum; 3 = uptake greater than \[\>\] mediastinum and ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly \> liver and/or new lesions). The CR criteria were slightly modified to require normal bone marrow by morphology (if indeterminate, immunohistochemistry negative). PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days) | The investigator evaluated responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based complete response (CR), which required a complete metabolic response with a score of 1, 2, or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to \[≤\] mediastinum; 3 = uptake greater than \[\>\] mediastinum and ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly \> liver and/or new lesions). The CR criteria were slightly modified to require normal bone marrow by morphology (if indeterminate, immunohistochemistry negative). PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were considered non-responders. |
| Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Lugano 2014 Criteria | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days) | The investigator evaluated responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based complete response (CR), which required a complete metabolic response with a score of 1, 2, or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to \[≤\] mediastinum; 3 = uptake greater than \[\>\] mediastinum and ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly \> liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma). The CR criteria for participants with bone marrow involvement at screening required no evidence of FDG-avid disease in the marrow. PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were considered non-responders. |
| Percentage of Participants With Complete Response at the End of Induction, Determined by the IRC on the Basis of CT Scans Alone Using Lugano 2014 Criteria | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days) | The IRC was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a computed tomography (CT)-based complete response (CR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 centimetres in the longest transverse diameter of a lesion \[LDi\]; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders. |
| Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days) | The investigator evaluated responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a computed tomography (CT)-based complete response (CR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 centimetres in the longest transverse diameter of a lesion \[LDi\]; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders. |
| Percentage of Participants With Objective Response at the End of Induction, Determined by the IRC on the Basis of PET-CT Scans Using Lugano 2014 Criteria | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days) | The IRC was to evaluate responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based objective response: either a complete (CR) or partial response (PR). A CR required a complete metabolic response with a score of 1, 2, or 3 on the PET 5-point scale (5PS) for 18-fluorodeoxyglucose (FDG) uptake (scores range from 1 \[no uptake above background\] to 5 \[uptake markedly higher than liver and/or new lesions\]), with or without a residual mass in lymph nodes and extralymphatic sites; and a PR required a partial metabolic response with a score of 4 or 5 on the 5PS with reduced 18-FDG uptake compared with baseline and residual mass(es) of any size. For bone marrow involvement, the CR criteria required no evidence of FDG-avid disease, and the PR criteria required residual uptake higher than in normal marrow but reduced compared with baseline. Participants without a post-baseline tumor assessment were to be considered non-responders. |
| Percentage of Participants With Objective Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Lugano 2014 Criteria | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days) | The investigator was to evaluate responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based objective response: either a complete (CR) or partial response (PR). A CR required a complete metabolic response with a score of 1, 2, or 3 on the PET 5-point scale (5PS) for 18-fluorodeoxyglucose (FDG) uptake (scores range from 1 \[no uptake above background\] to 5 \[uptake markedly higher than liver and/or new lesions\]), with or without a residual mass in lymph nodes and extralymphatic sites; and a PR required a partial metabolic response with a score of 4 or 5 on the 5PS with reduced 18-FDG uptake compared with baseline and residual mass(es) of any size. For bone marrow involvement, the CR criteria required no evidence of FDG-avid disease, and the PR criteria required residual uptake higher than in normal marrow but reduced compared with baseline. Participants without a post-baseline tumor assessment were to be considered non-responders. |
| Percentage of Participants With Objective Response at the End of Induction, Determined by an IRC on the Basis of CT Scans Alone Using Lugano 2014 Criteria | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days) | The IRC was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a ≥50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by \>50% in length. Participants without a post-baseline tumor assessment were to be considered non-responders. |
| Percentage of Participants With Objective Response at the End of Induction, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days) | The investigator was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a ≥50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by \>50% in length. Participants without a post-baseline tumor assessment were to be considered non-responders. |
| Percentage of Participants With Best Response of Complete Response or Partial Response During the Study, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria | Baseline, Cycle 2, end of induction (up to 6 cycles; 1 cycle is 28 days), every 2 months (FL) until end of maintenance or at 4 months (DLBCL) of consolidation treatment, and then every 6 months during follow-up until disease progression (up to 3.5 years) | The investigator was to evaluate responses throughout the study using the Lugano 2014 response criteria for malignant lymphoma for a CT-based best response of a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a ≥50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by \>50% in length. Participants without a post-baseline tumor assessment were to be considered non-responders. |
| Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Predose (0 hours) and 6 hours postdose on Day 1 of Cycles 1, 2, and 4; Predose (0 hours) and 2, 4, 6, and 24 hours postdose on Day 5 of Cycles 1 and 2; Predose (0 hours) and 6 and 24 hours postdose on Cycle 4, Day 5 (1 cycle is 28 days) | The concentration of idasanutlin was determined using a validated assay. The duplication of the predose timepoint (0 hours) on Day 5 as an additional 24-hour timepoint on Day 5 was done in order to conduct pharmacokinetics analysis via non-compartmental analysis, and to derive idasanutlin exposure estimates up to the 24-hour post Day 5 dosing. |
| Number of Participants With a Dose-Limiting Toxicity | Cycles 1, 2 (1 cycle is 28 days) | A dose-limiting toxicity (DLT) was defined as at least one of the following events occurring during Cycle 1 (or first 2 cycles in the bridging FL cohort) of treatment and assessed by the investigator as not clearly related to the underlying disease: Any Grade 5 adverse event (AE; severity graded per NCI-CTCAE v4.0) unless due to the underlying malignancy or extraneous causes; AE of any grade that leads to a delay of more than (\>)14 days in the start of the next treatment cycle; Grade 3 or 4 non-hematologic AEs (with exceptions); Lab results suggestive of potential drug-induced liver injury (according to Hy's law); Grade 3 or 4 neutropenia in the presence of sustained fever of \>38 C (lasting \>5 days) or a documented infection; Grade 4 neutropenia or thrombocytopenia lasting \>7 days; Grade 3 or 4 thrombocytopenia if associated with Grade ≥3 bleeding; Other toxicities considered clinically relevant and related to study treatment as determined by the investigator and medical monitor. |
| Serum Rituximab Concentrations in DLBCL Participants at Nominal Sampling Timepoints | Pre-infusion (0 hours) at Cycle 1, Day 1 and Cycle 2, Day 1; Post-infusion 0.5 hours at Cycle 1, Day 1 (1 cycle is 28 days) | — |
| Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | From first dose until 90 days after the last dose of study drug treatment (up to 31 months) | The adverse event (AE) severity grading scale for the NCI CTCAE v4.0 was used for assessing AE severity. Any AEs that were not specifically listed in the NCI CTCAE, v4.0 were graded per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. The terms severe and serious are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade. |
| Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6 (up to 6 cycles; 1 cycle is 28 days), and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (up to 29 months) | Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance |
| Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6 (up to 6 cycles; 1 cycle is 28 days), and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (up to 29 months) | Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance |
| Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6 (up to 6 cycles; 1 cycle is 28 days), and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (up to 29 months) | Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance |
| Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6 (up to 6 cycles; 1 cycle is 28 days), and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (up to 29 months) | Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance |
| Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6 (up to 6 cycles; 1 cycle is 28 days), and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (up to 29 months) | Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance |
| Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Baseline, Induction Cycle 1 Day 1 and Cycle 4 Day 1, End of Induction (up to 6 cycles; 1 cycle is 28 days); Every 2 months during maintenance treatment from Months 1-23; End of Maintenance (up to 24 months); Unscheduled Visits (as clinically indicated) | Single, resting, 12-lead ECG recordings were to be obtained after the participant had been resting in a supine position for at least 10 minutes. Any morphologic waveform changes or other ECG abnormalities were to be documented and clinical significance was determined based on the presence of symptoms, per the investigator's judgment. If the ECG assessment was missing at baseline then it was recorded as Missing. The ECG results assessments are presented as the shift from baseline to post-baseline assessments at each timepoint. BL = baseline; Cyc1, D1 = Induction Cycle 1 Day 1; Cyc4, D1 = Induction Cycle 4 Day 1; CS = Clinically Significant; EOI = End of Induction Treatment - Completion/Discontinuation; EOM = End of Maintenance Treatment - Completion/Discontinuation; MM1 = Maintenance Month 1; Unsched = Unscheduled Visit |
| Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | From Baseline until 35 days after the last dose of study drug (up to 29 months) | Clinical laboratory tests for hematology parameters were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest (worst) severity grade (according to NCI-CTCAE v4.0) at baseline to the highest grade post-baseline. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a medical intervention or a change in concomitant therapy. For a patient with multiple post-baseline abnormalities, the highest (worst) grade for a given lab test is reported. Abs. = absolute count; BL = baseline; WBC = white blood cell count |
| Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | From Baseline until 35 days after the last dose of study drug (up to 29 months) | Clinical laboratory tests for blood chemistry parameters were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest (worst) severity grade (according to NCI-CTCAE v4.0) at baseline to the highest grade post-baseline. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a medical intervention or a change in concomitant therapy. For a patient with multiple post-baseline abnormalities, the highest (worst) grade for a given lab test is reported. BL = Baseline; Blood Gluc., Fast. = blood glucose, fasting; SGOT/AST = serum glutamic-oxaloacetic transaminase/aspartate transaminase; SGPT/ALT = serum glutamic-pyruvic transaminase/alanine transaminase; Triacylglyc. Lipase = triacylglycerol lipase |
| Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints | Pre-infusion (0 hour) and 0.5 hours after end of obinutuzumab infusion on Day 1 of Cycles 1, 2, 4, and 6 | — |
Countries
Australia, Germany, New Zealand, South Korea, United States
Participant flow
Pre-assignment details
A total of 45 patients were screened, twenty-five of whom were enrolled in the dose escalation phase. The sponsor decided to terminate the study early and the expansion phase was not opened.
Participants by arm
| Arm | Count |
|---|---|
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days). | 2 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days). | 3 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days). | 2 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days). | 3 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days). | 4 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days). | 2 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days). | 4 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days). | 5 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 2 | 2 | 2 | 0 | 0 | 1 |
| Overall Study | Progressive Disease | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Study Terminated by Sponsor | 1 | 1 | 0 | 1 | 2 | 2 | 4 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 60.6 Years STANDARD_DEVIATION 10.8 | 62.5 Years STANDARD_DEVIATION 6.4 | 70.7 Years STANDARD_DEVIATION 15.2 | 55.5 Years STANDARD_DEVIATION 10.6 | 67.3 Years STANDARD_DEVIATION 8.4 | 56.5 Years STANDARD_DEVIATION 12.9 | 52.5 Years STANDARD_DEVIATION 6.4 | 53.3 Years STANDARD_DEVIATION 6.7 | 64.2 Years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 2 Participants | 3 Participants | 0 Participants | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Female | 12 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 13 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 1 / 3 | 2 / 2 | 2 / 3 | 2 / 4 | 0 / 2 | 0 / 4 | 1 / 5 |
| other Total, other adverse events | 1 / 1 | 3 / 3 | 2 / 2 | 3 / 3 | 4 / 4 | 2 / 2 | 4 / 4 | 5 / 5 |
| serious Total, serious adverse events | 1 / 1 | 1 / 3 | 1 / 2 | 0 / 3 | 2 / 4 | 1 / 2 | 1 / 4 | 2 / 5 |
Outcome results
Primary
Percentage of Participants With Complete Response at the End of Induction, Determined by an Independent Review Committee (IRC) on the Basis of Positron Emission Tomography and Computed Tomography (PET-CT) Scans Using Modified Lugano 2014 Criteria
The plan was for the IRC to evaluate responses at the end of induction treatment in participants from the expansion phase using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based complete response (CR), which required a complete metabolic response with a score of 1, 2, or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to \[≤\] mediastinum; 3 = uptake greater than \[\>\] mediastinum and ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly \> liver and/or new lesions). The CR criteria were slightly modified to require normal bone marrow by morphology (if indeterminate, immunohistochemistry negative). PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders.
Time frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
Population: The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Phase 2), but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Phase 1).
Secondary
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints
Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance
Time frame: Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6 (up to 6 cycles; 1 cycle is 28 days), and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (up to 29 months)
Population: Safety Population: participants who received at least one dose of any component of the combination treatment. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 4 Day 1 | 0.00 degrees Celsius (C) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Baseline (BL) - Value at Visit | 36.60 degrees Celsius (C) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 8 | 0.10 degrees Celsius (C) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Follow-Up | 0.10 degrees Celsius (C) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 0.00 degrees Celsius (C) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 3 Day 1 | -0.20 degrees Celsius (C) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 15 | 0.10 degrees Celsius (C) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 5 Day 1 | 0.20 degrees Celsius (C) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 0.00 degrees Celsius (C) | — |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 3 Day 1 | -0.10 degrees Celsius (C) | — |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 0.10 degrees Celsius (C) | Standard Deviation 0.14 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Baseline (BL) - Value at Visit | 36.47 degrees Celsius (C) | Standard Deviation 0.45 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 0.00 degrees Celsius (C) | Standard Deviation 0.92 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 8 | 0.37 degrees Celsius (C) | Standard Deviation 0.5 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 15 | 0.20 degrees Celsius (C) | Standard Deviation 0.82 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Follow-Up | 0.00 degrees Celsius (C) | Standard Deviation 0.14 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 8 | 0.95 degrees Celsius (C) | Standard Deviation 0.85 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 1 | -0.15 degrees Celsius (C) | Standard Deviation 0.21 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Baseline (BL) - Value at Visit | 36.35 degrees Celsius (C) | Standard Deviation 0.21 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 1 | -0.07 degrees Celsius (C) | Standard Deviation 0.15 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Follow-Up | -0.40 degrees Celsius (C) | Standard Deviation 0.14 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 2 Day 1 | -0.30 degrees Celsius (C) | Standard Deviation 0.14 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Baseline (BL) - Value at Visit | 36.83 degrees Celsius (C) | Standard Deviation 0.15 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Follow-Up | 0.53 degrees Celsius (C) | Standard Deviation 0.71 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 0.18 degrees Celsius (C) | Standard Deviation 0.33 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Baseline (BL) - Value at Visit | 36.58 degrees Celsius (C) | Standard Deviation 0.34 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Maint. Month 5 | 0.20 degrees Celsius (C) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Baseline (BL) - Value at Visit | 36.55 degrees Celsius (C) | Standard Deviation 0.21 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 0.05 degrees Celsius (C) | Standard Deviation 0.49 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 8 | 0.30 degrees Celsius (C) | Standard Deviation 0.28 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 15 | 0.20 degrees Celsius (C) | Standard Deviation 0.28 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 2 Day 1 | -0.50 degrees Celsius (C) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 3 Day 1 | -0.10 degrees Celsius (C) | Standard Deviation 0.42 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 4 Day 1 | 0.05 degrees Celsius (C) | Standard Deviation 0.64 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 5 Day 1 | 0.35 degrees Celsius (C) | Standard Deviation 0.64 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 6 Day 1 | 0.20 degrees Celsius (C) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Maint. Month 1 | 0.60 degrees Celsius (C) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Maint. Month 3 | 0.40 degrees Celsius (C) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Maint. Month 7 | 0.60 degrees Celsius (C) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Maint. Month 9 | 0.30 degrees Celsius (C) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Maint. Month 11 | 0.70 degrees Celsius (C) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Maint. Month 13 | 0.40 degrees Celsius (C) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Maint. Month 15 | 0.70 degrees Celsius (C) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Maint. Month 17 | 0.40 degrees Celsius (C) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Maint. Month 19 | 0.80 degrees Celsius (C) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Maint. Month 21 | 0.50 degrees Celsius (C) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Follow-Up | 0.30 degrees Celsius (C) | Standard Deviation 0.57 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 6 Day 1 | 0.20 degrees Celsius (C) | — |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Baseline (BL) - Value at Visit | 36.50 degrees Celsius (C) | Standard Deviation 0.18 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 8 | -0.13 degrees Celsius (C) | Standard Deviation 0.22 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 2 Day 1 | -0.25 degrees Celsius (C) | Standard Deviation 0.49 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Follow-Up | -0.15 degrees Celsius (C) | Standard Deviation 0.47 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 3 Day 1 | -0.50 degrees Celsius (C) | Standard Deviation 0.28 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 15 | -0.23 degrees Celsius (C) | Standard Deviation 0.45 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 4 Day 1 | 0.05 degrees Celsius (C) | Standard Deviation 0.21 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 5 Day 1 | -0.35 degrees Celsius (C) | Standard Deviation 0.49 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 0.30 degrees Celsius (C) | Standard Deviation 0.22 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 2 Day 1 | -0.04 degrees Celsius (C) | Standard Deviation 0.09 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 5 Day 1 | -0.20 degrees Celsius (C) | Standard Deviation 0.14 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 15 | -0.18 degrees Celsius (C) | Standard Deviation 0.26 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 4 Day 1 | -0.10 degrees Celsius (C) | — |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 8 | 0.10 degrees Celsius (C) | Standard Deviation 0.45 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 3 Day 1 | -0.17 degrees Celsius (C) | Standard Deviation 0.21 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 6 Day 1 | -0.05 degrees Celsius (C) | Standard Deviation 0.21 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Baseline (BL) - Value at Visit | 36.70 degrees Celsius (C) | Standard Deviation 3.3 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Maint. Month 1 | -0.20 degrees Celsius (C) | Standard Deviation 0.14 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Cycle 1 Day 1 | -0.18 degrees Celsius (C) | Standard Deviation 0.3 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Maint. Month 3 | -0.20 degrees Celsius (C) | Standard Deviation 0.57 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Maint. Month 9 | 0.20 degrees Celsius (C) | — |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Maint. Month 5 | -0.20 degrees Celsius (C) | — |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Follow-Up | -0.10 degrees Celsius (C) | Standard Deviation 0.24 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints | Change from BL at Maint. Month 7 | -0.10 degrees Celsius (C) | — |
Secondary
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints
Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance
Time frame: Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6 (up to 6 cycles; 1 cycle is 28 days), and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (up to 29 months)
Population: Safety Population: participants who received at least one dose of any component of the combination treatment. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 4 Day 1 | -4.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Baseline (BL) - Value at Visit | 100.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 8 | -1.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Follow-Up | -16.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 7.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 3 Day 1 | 3.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 15 | -1.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 5 Day 1 | -2.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 1 | -17.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 3 Day 1 | 3.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 0.0 millimeters of mercury (mmHg) | Standard Deviation 17 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Baseline (BL) - Value at Visit | 67.3 millimeters of mercury (mmHg) | Standard Deviation 12.1 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 1 | -2.0 millimeters of mercury (mmHg) | Standard Deviation 19.5 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 8 | 1.3 millimeters of mercury (mmHg) | Standard Deviation 15 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 15 | 3.0 millimeters of mercury (mmHg) | Standard Deviation 16.4 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Follow-Up | -9.0 millimeters of mercury (mmHg) | Standard Deviation 21.2 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 8 | -2.5 millimeters of mercury (mmHg) | Standard Deviation 6.4 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 1 | -2.5 millimeters of mercury (mmHg) | Standard Deviation 2.1 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Baseline (BL) - Value at Visit | 72.0 millimeters of mercury (mmHg) | Standard Deviation 9.9 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 7.3 millimeters of mercury (mmHg) | Standard Deviation 23.1 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Follow-Up | -15.5 millimeters of mercury (mmHg) | Standard Deviation 20.5 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 3.5 millimeters of mercury (mmHg) | Standard Deviation 13.4 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Baseline (BL) - Value at Visit | 72.3 millimeters of mercury (mmHg) | Standard Deviation 12.3 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Follow-Up | 4.0 millimeters of mercury (mmHg) | Standard Deviation 4.2 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 1 | -2.3 millimeters of mercury (mmHg) | Standard Deviation 7.4 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Baseline (BL) - Value at Visit | 70.3 millimeters of mercury (mmHg) | Standard Deviation 7.6 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 5 | -7.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Baseline (BL) - Value at Visit | 71.5 millimeters of mercury (mmHg) | Standard Deviation 9.2 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 1 | -2.0 millimeters of mercury (mmHg) | Standard Deviation 4.2 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 8 | -2.0 millimeters of mercury (mmHg) | Standard Deviation 0 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 15 | 6.0 millimeters of mercury (mmHg) | Standard Deviation 4.2 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 0.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 3 Day 1 | -5.5 millimeters of mercury (mmHg) | Standard Deviation 6.4 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 4 Day 1 | 3.0 millimeters of mercury (mmHg) | Standard Deviation 8.5 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 5 Day 1 | 3.5 millimeters of mercury (mmHg) | Standard Deviation 0.7 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 6 Day 1 | 10.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 1 | 0.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 3 | 14.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 7 | 7.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 9 | 6.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 11 | -13.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 13 | 1.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 15 | 9.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 17 | -4.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 19 | 7.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 21 | 0.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Follow-Up | 10.5 millimeters of mercury (mmHg) | Standard Deviation 2.1 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 6 Day 1 | 9.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Baseline (BL) - Value at Visit | 76.3 millimeters of mercury (mmHg) | Standard Deviation 12.7 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 8 | -6.5 millimeters of mercury (mmHg) | Standard Deviation 1.3 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 2 Day 1 | -8.0 millimeters of mercury (mmHg) | Standard Deviation 2.8 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Follow-Up | 7.5 millimeters of mercury (mmHg) | Standard Deviation 20.2 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 3 Day 1 | -1.0 millimeters of mercury (mmHg) | Standard Deviation 4.2 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 15 | 0.0 millimeters of mercury (mmHg) | Standard Deviation 6.6 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 4 Day 1 | -8.0 millimeters of mercury (mmHg) | Standard Deviation 7.1 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 5 Day 1 | -2.0 millimeters of mercury (mmHg) | Standard Deviation 7.1 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 3.0 millimeters of mercury (mmHg) | Standard Deviation 4.9 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 12.0 millimeters of mercury (mmHg) | Standard Deviation 5.1 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 5 Day 1 | 2.5 millimeters of mercury (mmHg) | Standard Deviation 4.9 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 15 | 2.4 millimeters of mercury (mmHg) | Standard Deviation 8.3 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 4 Day 1 | 7.0 millimeters of mercury (mmHg) | — |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 8 | 9.2 millimeters of mercury (mmHg) | Standard Deviation 8.5 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 3 Day 1 | 5.3 millimeters of mercury (mmHg) | Standard Deviation 5 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 6 Day 1 | 2.5 millimeters of mercury (mmHg) | Standard Deviation 3.5 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Baseline (BL) - Value at Visit | 65.8 millimeters of mercury (mmHg) | Standard Deviation 6.9 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 1 | 2.0 millimeters of mercury (mmHg) | Standard Deviation 0 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 6.4 millimeters of mercury (mmHg) | Standard Deviation 2.1 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 3 | 5.0 millimeters of mercury (mmHg) | Standard Deviation 8.5 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 9 | 3.0 millimeters of mercury (mmHg) | — |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 5 | -5.0 millimeters of mercury (mmHg) | — |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Follow-Up | 9.3 millimeters of mercury (mmHg) | Standard Deviation 3.3 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 7 | -1.0 millimeters of mercury (mmHg) | — |
Secondary
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints
Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance
Time frame: Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6 (up to 6 cycles; 1 cycle is 28 days), and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (up to 29 months)
Population: Safety Population: participants who received at least one dose of any component of the combination treatment. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 8 | -2.0 beats per minute | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 4.0 beats per minute | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 3 Day 1 | -1.0 beats per minute | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Baseline (BL) - Value at Visit | 73.0 beats per minute | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 15 | -11.0 beats per minute | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 4 Day 1 | 1.0 beats per minute | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 10.0 beats per minute | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 5 Day 1 | 15.0 beats per minute | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Follow-Up | 15.0 beats per minute | — |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 8 | 11.0 beats per minute | Standard Deviation 2 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 17.5 beats per minute | Standard Deviation 17.7 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 15 | 12.7 beats per minute | Standard Deviation 13.4 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 3 Day 1 | 19.0 beats per minute | — |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Baseline (BL) - Value at Visit | 65.7 beats per minute | Standard Deviation 1.2 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 15.7 beats per minute | Standard Deviation 21.5 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Follow-Up | -20.0 beats per minute | Standard Deviation 18.4 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 8 | -2.0 beats per minute | Standard Deviation 1.4 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Baseline (BL) - Value at Visit | 100.5 beats per minute | Standard Deviation 17.7 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 1 | -9.0 beats per minute | Standard Deviation 8.5 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 0.0 beats per minute | Standard Deviation 9.8 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Follow-Up | 11.5 beats per minute | Standard Deviation 10.6 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Baseline (BL) - Value at Visit | 81.7 beats per minute | Standard Deviation 3.1 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 7.0 beats per minute | Standard Deviation 1.4 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 8.8 beats per minute | Standard Deviation 12 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Follow-Up | 23.5 beats per minute | Standard Deviation 20.5 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Baseline (BL) - Value at Visit | 76.0 beats per minute | Standard Deviation 10.6 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Maint. Month 5 | -5.0 beats per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 5 Day 1 | -6.5 beats per minute | Standard Deviation 10.6 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Baseline (BL) - Value at Visit | 77.5 beats per minute | Standard Deviation 12 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 2.5 beats per minute | Standard Deviation 14.8 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 8 | -0.5 beats per minute | Standard Deviation 20.5 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 15 | -3.5 beats per minute | Standard Deviation 16.3 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 2 Day 1 | -17.0 beats per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 3 Day 1 | -1.5 beats per minute | Standard Deviation 16.3 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 4 Day 1 | -7.0 beats per minute | Standard Deviation 12.7 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 6 Day 1 | -1.0 beats per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Maint. Month 1 | 6.0 beats per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Maint. Month 3 | 0.0 beats per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Maint. Month 7 | 1.0 beats per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Maint. Month 9 | 6.0 beats per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Maint. Month 11 | 18.0 beats per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Maint. Month 13 | 11.0 beats per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Maint. Month 15 | 2.0 beats per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Maint. Month 17 | -2.0 beats per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Maint. Month 19 | 1.0 beats per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Maint. Month 21 | 13.0 beats per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Follow-Up | 15.0 beats per minute | Standard Deviation 8.5 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 2.3 beats per minute | Standard Deviation 6.4 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Baseline (BL) - Value at Visit | 79.5 beats per minute | Standard Deviation 18.6 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 8 | 2.3 beats per minute | Standard Deviation 6.4 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Follow-Up | 5.8 beats per minute | Standard Deviation 14.8 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 2 Day 1 | -2.5 beats per minute | Standard Deviation 4.9 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 3 Day 1 | -4.5 beats per minute | Standard Deviation 20.5 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 15 | -1.7 beats per minute | Standard Deviation 13.1 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 4 Day 1 | -5.0 beats per minute | Standard Deviation 5.7 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 5 Day 1 | 3.0 beats per minute | Standard Deviation 28.3 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 6 Day 1 | 31.0 beats per minute | — |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 9.0 beats per minute | Standard Deviation 11.1 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 6.4 beats per minute | Standard Deviation 9.7 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 5 Day 1 | 6.5 beats per minute | Standard Deviation 4.9 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 15 | 3.2 beats per minute | Standard Deviation 14.5 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Maint. Month 9 | 11.0 beats per minute | — |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 4 Day 1 | 4.0 beats per minute | — |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 6 Day 1 | 15.0 beats per minute | Standard Deviation 2.8 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Baseline (BL) - Value at Visit | 80.2 beats per minute | Standard Deviation 9.9 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Maint. Month 1 | 10.0 beats per minute | Standard Deviation 5.7 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 3 Day 1 | -3.5 beats per minute | Standard Deviation 10.6 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Maint. Month 3 | 2.0 beats per minute | Standard Deviation 9.9 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Cycle 1 Day 8 | 9.0 beats per minute | Standard Deviation 11.1 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Maint. Month 5 | 11.0 beats per minute | — |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Follow-Up | 10.3 beats per minute | Standard Deviation 9.2 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints | Change from BL at Maint. Month 7 | 2.0 beats per minute | — |
Secondary
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints
Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance
Time frame: Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6 (up to 6 cycles; 1 cycle is 28 days), and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (up to 29 months)
Population: Safety Population: participants who received at least one dose of any component of the combination treatment. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Follow-Up | -2.0 breaths per minute | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 0.0 breaths per minute | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 0.0 breaths per minute | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 4 Day 1 | -2.0 breaths per minute | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 15 | 0.0 breaths per minute | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 3 Day 1 | 2.0 breaths per minute | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 5 Day 1 | 0.0 breaths per minute | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Baseline (BL) - Value at Visit | 18.0 breaths per minute | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 8 | 0.0 breaths per minute | — |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 3 Day 1 | -4.0 breaths per minute | — |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 2 Day 1 | -2.5 breaths per minute | Standard Deviation 3.5 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 0.7 breaths per minute | Standard Deviation 1.2 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Baseline (BL) - Value at Visit | 17.0 breaths per minute | Standard Deviation 2.6 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 8 | -1.7 breaths per minute | Standard Deviation 2.1 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 15 | -3.5 breaths per minute | Standard Deviation 2.1 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Follow-Up | -2.0 breaths per minute | Standard Deviation 2.8 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 8 | -1.0 breaths per minute | Standard Deviation 1.4 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Baseline (BL) - Value at Visit | 19.0 breaths per minute | Standard Deviation 1.4 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 1 | -1.0 breaths per minute | Standard Deviation 1.4 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 0.5 breaths per minute | Standard Deviation 0.7 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 1 | -0.7 breaths per minute | Standard Deviation 1.2 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Follow-Up | -4.0 breaths per minute | — |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Baseline (BL) - Value at Visit | 17.0 breaths per minute | Standard Deviation 1.7 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 0.3 breaths per minute | Standard Deviation 1.3 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Follow-Up | 0.0 breaths per minute | Standard Deviation 2.8 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Baseline (BL) - Value at Visit | 17.0 breaths per minute | Standard Deviation 2 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Maint. Month 5 | 0.0 breaths per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 15 | 1.0 breaths per minute | Standard Deviation 1.4 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Baseline (BL) - Value at Visit | 16.0 breaths per minute | Standard Deviation 0 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 1.0 breaths per minute | Standard Deviation 1.4 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 8 | 0.0 breaths per minute | Standard Deviation 0 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 0.0 breaths per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 3 Day 1 | 0.0 breaths per minute | Standard Deviation 0 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 4 Day 1 | 0.0 breaths per minute | Standard Deviation 0 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 5 Day 1 | 0.0 breaths per minute | Standard Deviation 0 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 6 Day 1 | -4.0 breaths per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Maint. Month 1 | -4.0 breaths per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Maint. Month 3 | 0.0 breaths per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Maint. Month 7 | 0.0 breaths per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Maint. Month 9 | 2.0 breaths per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Maint. Month 11 | 0.0 breaths per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Maint. Month 13 | 0.0 breaths per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Maint. Month 15 | 0.0 breaths per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Maint. Month 17 | 2.0 breaths per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Maint. Month 19 | 0.0 breaths per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Maint. Month 21 | 2.0 breaths per minute | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Follow-Up | 1.0 breaths per minute | Standard Deviation 1.4 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 6 Day 1 | 5.0 breaths per minute | — |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Baseline (BL) - Value at Visit | 16.0 breaths per minute | Standard Deviation 3.3 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 8 | 2.0 breaths per minute | Standard Deviation 4 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 4.0 breaths per minute | Standard Deviation 5.7 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Follow-Up | 3.3 breaths per minute | Standard Deviation 3.2 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 3 Day 1 | 4.0 breaths per minute | Standard Deviation 5.7 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 15 | 1.7 breaths per minute | Standard Deviation 1.5 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 4 Day 1 | 2.0 breaths per minute | Standard Deviation 2.8 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 5 Day 1 | 1.0 breaths per minute | Standard Deviation 1.4 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 2.3 breaths per minute | Standard Deviation 0.5 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 0.0 breaths per minute | Standard Deviation 4.6 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 5 Day 1 | 0.0 breaths per minute | Standard Deviation 5.7 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 15 | -0.2 breaths per minute | Standard Deviation 2.7 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 4 Day 1 | 4.0 breaths per minute | — |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 8 | 0.0 breaths per minute | Standard Deviation 2.4 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 3 Day 1 | -1.0 breaths per minute | Standard Deviation 4.2 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 6 Day 1 | -2.0 breaths per minute | Standard Deviation 2.8 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Baseline (BL) - Value at Visit | 16.8 breaths per minute | Standard Deviation 3 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Maint. Month 1 | -1.0 breaths per minute | Standard Deviation 4.2 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 0.0 breaths per minute | Standard Deviation 0 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Maint. Month 3 | -2.0 breaths per minute | Standard Deviation 2.8 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Maint. Month 9 | -4.0 breaths per minute | — |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Maint. Month 5 | -4.0 breaths per minute | — |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Follow-Up | -0.7 breaths per minute | Standard Deviation 3.1 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints | Change from BL at Maint. Month 7 | -4.0 breaths per minute | — |
Secondary
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints
Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance
Time frame: Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6 (up to 6 cycles; 1 cycle is 28 days), and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (up to 29 months)
Population: Safety Population: participants who received at least one dose of any component of the combination treatment. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 4 Day 1 | -22.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Baseline (BL) - Value at Visit | 176.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 8 | -4.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Follow-Up | -32.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 2 Day 1 | -17.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 3 Day 1 | -1.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 15 | 24.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 5 Day 1 | -21.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 1 | -34.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 3 Day 1 | 11.0 millimeters of mercury (mmHg) | — |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 2 Day 1 | -3.5 millimeters of mercury (mmHg) | Standard Deviation 19.1 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Baseline (BL) - Value at Visit | 124.0 millimeters of mercury (mmHg) | Standard Deviation 7.9 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 1 | -2.0 millimeters of mercury (mmHg) | Standard Deviation 10.5 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 8 | -5.0 millimeters of mercury (mmHg) | Standard Deviation 8.5 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 15 | -5.3 millimeters of mercury (mmHg) | Standard Deviation 14.6 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Follow-Up | -3.5 millimeters of mercury (mmHg) | Standard Deviation 9.2 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 8 | -7.0 millimeters of mercury (mmHg) | Standard Deviation 8.5 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 1 | -5.0 millimeters of mercury (mmHg) | Standard Deviation 4.2 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Baseline (BL) - Value at Visit | 107.5 millimeters of mercury (mmHg) | Standard Deviation 2.1 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 1 | -2.7 millimeters of mercury (mmHg) | Standard Deviation 14.6 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Follow-Up | -25.0 millimeters of mercury (mmHg) | Standard Deviation 55.2 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 0.0 millimeters of mercury (mmHg) | Standard Deviation 39.6 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Baseline (BL) - Value at Visit | 125.7 millimeters of mercury (mmHg) | Standard Deviation 39.4 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Follow-Up | -3.5 millimeters of mercury (mmHg) | Standard Deviation 0.7 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 1 | -0.8 millimeters of mercury (mmHg) | Standard Deviation 10.6 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Baseline (BL) - Value at Visit | 119.0 millimeters of mercury (mmHg) | Standard Deviation 16.8 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 5 | -12.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Baseline (BL) - Value at Visit | 120.5 millimeters of mercury (mmHg) | Standard Deviation 17.7 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 1 | -3.5 millimeters of mercury (mmHg) | Standard Deviation 10.6 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 8 | -6.5 millimeters of mercury (mmHg) | Standard Deviation 6.4 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 15 | -3.5 millimeters of mercury (mmHg) | Standard Deviation 7.8 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 2 Day 1 | -14.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 3 Day 1 | -13.5 millimeters of mercury (mmHg) | Standard Deviation 3.5 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 4 Day 1 | 12.5 millimeters of mercury (mmHg) | Standard Deviation 27.6 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 5 Day 1 | 0.5 millimeters of mercury (mmHg) | Standard Deviation 4.9 |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 6 Day 1 | -2.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 1 | -14.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 3 | 9.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 7 | -5.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 9 | -3.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 11 | -5.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 13 | -5.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 15 | -9.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 17 | -35.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 19 | 2.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 21 | -21.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Follow-Up | 9.5 millimeters of mercury (mmHg) | Standard Deviation 3.5 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 6 Day 1 | 20.0 millimeters of mercury (mmHg) | — |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Baseline (BL) - Value at Visit | 109.3 millimeters of mercury (mmHg) | Standard Deviation 9.1 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 8 | -2.3 millimeters of mercury (mmHg) | Standard Deviation 15.2 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 4.5 millimeters of mercury (mmHg) | Standard Deviation 4.9 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Follow-Up | 20.0 millimeters of mercury (mmHg) | Standard Deviation 15.5 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 3 Day 1 | 10.5 millimeters of mercury (mmHg) | Standard Deviation 2.1 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 15 | 9.7 millimeters of mercury (mmHg) | Standard Deviation 13.4 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 4 Day 1 | 2.0 millimeters of mercury (mmHg) | Standard Deviation 1.4 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 5 Day 1 | 12.5 millimeters of mercury (mmHg) | Standard Deviation 9.2 |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 3.5 millimeters of mercury (mmHg) | Standard Deviation 9.4 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 2 Day 1 | 8.6 millimeters of mercury (mmHg) | Standard Deviation 10.4 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 5 Day 1 | 8.5 millimeters of mercury (mmHg) | Standard Deviation 9.2 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 15 | 8.0 millimeters of mercury (mmHg) | Standard Deviation 12.9 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 4 Day 1 | -10.0 millimeters of mercury (mmHg) | — |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 8 | 6.4 millimeters of mercury (mmHg) | Standard Deviation 10.3 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 3 Day 1 | 7.0 millimeters of mercury (mmHg) | Standard Deviation 8.9 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 6 Day 1 | 0.5 millimeters of mercury (mmHg) | Standard Deviation 0.7 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Baseline (BL) - Value at Visit | 116.4 millimeters of mercury (mmHg) | Standard Deviation 10.5 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 1 | 14.0 millimeters of mercury (mmHg) | Standard Deviation 9.9 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Cycle 1 Day 1 | 4.8 millimeters of mercury (mmHg) | Standard Deviation 14.8 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 3 | 7.5 millimeters of mercury (mmHg) | Standard Deviation 10.6 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 9 | 7.0 millimeters of mercury (mmHg) | — |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 5 | 9.0 millimeters of mercury (mmHg) | — |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Follow-Up | -1.3 millimeters of mercury (mmHg) | Standard Deviation 9 |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints | Change from BL at Maint. Month 7 | 0.0 millimeters of mercury (mmHg) | — |
Secondary
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline
Clinical laboratory tests for blood chemistry parameters were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest (worst) severity grade (according to NCI-CTCAE v4.0) at baseline to the highest grade post-baseline. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a medical intervention or a change in concomitant therapy. For a patient with multiple post-baseline abnormalities, the highest (worst) grade for a given lab test is reported. BL = Baseline; Blood Gluc., Fast. = blood glucose, fasting; SGOT/AST = serum glutamic-oxaloacetic transaminase/aspartate transaminase; SGPT/ALT = serum glutamic-pyruvic transaminase/alanine transaminase; Triacylglyc. Lipase = triacylglycerol lipase
Time frame: From Baseline until 35 days after the last dose of study drug (up to 29 months)
Population: Safety Population: participants who received at least one dose of any component of the combination treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Bilirubin (umol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (All) | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 2 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Bilirubin (umol/L), High: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGOT/AST (U/L), High: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), High: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Missing (BL) to Gr. 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), High: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 1 (BL) to 1 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 3 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 4 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), Low: Missing(BL) to Gr 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Missing (All) | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 2 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc.,Fast.(mmol/L), High: Missing (All) | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Missing (BL) to Gr. 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Gr. 0(BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGOT/AST (U/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Missing (All) | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 3 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Gr. 0 (BL) to 3 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (BL) to Gr. 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Missing (BL) to Gr. 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc.,Fast.(mmol/L), Low: Missing (All) | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), High: Gr. 0 (BL) to 1 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Missing(BL) to Gr. 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (BL) to Gr. 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 1 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 2 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc.,Fast.(mmol/L), High: Missing (All) | 3 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Bilirubin (umol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGOT/AST (U/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Gr. 0(BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 3 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 4 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Missing(BL) to Gr. 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 0 | 3 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Missing (BL) to Gr. 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Bilirubin (umol/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 1 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 1 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Missing (BL) to Gr. 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Missing (All) | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 1 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Missing (BL) to Gr. 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Gr. 0 (BL) to 1 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Missing (All) | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc.,Fast.(mmol/L), Low: Missing (All) | 3 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (BL) to Gr. 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (BL) to Gr. 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), Low: Missing(BL) to Gr 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (All) | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGOT/AST (U/L), High: Gr. 1 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (BL) to Gr. 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 1 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), Low: Missing(BL) to Gr 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 4 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (BL) to Gr. 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Missing(BL) to Gr. 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc.,Fast.(mmol/L), High: Missing (All) | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Missing (All) | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Gr. 0(BL) to 1 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGOT/AST (U/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (All) | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Missing (BL) to Gr. 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Gr. 1 (BL) to 1 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 3 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Bilirubin (umol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 2 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Missing (All) | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGOT/AST (U/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Missing (BL) to Gr. 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Missing (BL) to Gr. 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc.,Fast.(mmol/L), Low: Missing (All) | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Bilirubin (umol/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 1 | 2 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 1 | 2 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (All) | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), High: Gr. 0 (BL) to 1 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 1 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 1 (BL) to 1 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (BL) to Gr. 0 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Missing (BL) to Gr. 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 0 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), Low: Missing(BL) to Gr 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Bilirubin (umol/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Gr. 0 (BL) to 1 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc.,Fast.(mmol/L), Low: Missing (All) | 3 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 3 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Bilirubin (umol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (BL) to Gr. 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 1 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Missing (BL) to Gr. 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Missing(BL) to Gr. 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 2 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGOT/AST (U/L), High: Gr. 1 (BL) to 0 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Missing (All) | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGOT/AST (U/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 4 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Missing (BL) to Gr. 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Missing (All) | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc.,Fast.(mmol/L), High: Missing (All) | 3 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 2 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Gr. 0(BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 1 (BL) to 1 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 1 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 0 | 4 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 0 | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 2 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 1 (BL) to 1 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Missing (BL) to Gr. 0 | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Gr. 1 (BL) to 1 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Bilirubin (umol/L), High: Gr. 0 (BL) to 0 | 4 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 1 | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 0 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 2 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Gr. 0 (BL) to 0 | 4 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Missing (BL) to Gr. 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Missing (All) | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Gr. 0 (BL) to 0 | 4 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Missing (BL) to Gr. 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Missing (All) | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (BL) to Gr. 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (BL) to Gr. 2 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (All) | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 0 (BL) to 2 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 2 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGOT/AST (U/L), High: Gr. 0 (BL) to 0 | 4 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Bilirubin (umol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Gr. 0(BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc.,Fast.(mmol/L), High: Missing (All) | 4 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGOT/AST (U/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), Low: Missing(BL) to Gr 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc.,Fast.(mmol/L), Low: Missing (All) | 4 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), High: Gr. 1 (BL) to 0 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 1 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 1 (BL) to 1 | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 2 | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), High: Gr. 0 (BL) to 0 | 4 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Missing(BL) to Gr. 0 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 3 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 4 (BL) to 3 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 1 (BL) to 0 | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGOT/AST (U/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc.,Fast.(mmol/L), High: Missing (All) | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (All) | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (BL) to Gr. 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), Low: Missing(BL) to Gr 0 | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (BL) to Gr. 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc.,Fast.(mmol/L), Low: Missing (All) | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Missing (All) | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Missing (BL) to Gr. 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Missing (All) | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 4 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Missing (BL) to Gr. 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Bilirubin (umol/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Missing (BL) to Gr. 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 0 | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 1 | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 1 | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 0 | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 1 | 2 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Missing(BL) to Gr. 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 3 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Gr. 0(BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 0 | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Bilirubin (umol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 2 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGOT/AST (U/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), High: Gr. 0 (BL) to 0 | 4 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Gr. 0 (BL) to 0 | 4 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Bilirubin (umol/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 4 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 0 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 0 (BL) to 0 | 4 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 1 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 1 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 0 | 4 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Missing (BL) to Gr. 0 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 0 (BL) to 0 | 4 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGOT/AST (U/L), High: Gr. 0 (BL) to 0 | 4 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 0 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 0 | 4 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Gr. 0(BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 0 (BL) to 0 | 4 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGOT/AST (U/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc.,Fast.(mmol/L), High: Missing (All) | 3 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (All) | 2 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (BL) to Gr. 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (BL) to Gr. 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 3 (BL) to 3 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Bilirubin (umol/L), High: Gr. 0 (BL) to 1 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), Low: Missing(BL) to Gr 0 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 2 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc.,Fast.(mmol/L), Low: Missing (All) | 3 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Missing (All) | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 0 | 4 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), High: Gr. 0 (BL) to 0 | 4 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Missing (BL) to Gr. 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Gr. 0 (BL) to 0 | 4 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 0 | 3 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Missing (All) | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Missing(BL) to Gr. 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 1 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Missing (BL) to Gr. 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 2 (BL) to 2 | 2 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Gr. 0(BL) to 1 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Gr. 0 (BL) to 0 | 5 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 0 | 3 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Missing(BL) to Gr. 0 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 2 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 2 (BL) to 0 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 0 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 2 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Gr. 0 (BL) to 1 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGOT/AST (U/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Missing (BL) to Gr. 0 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 0 (BL) to 0 | 5 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 0 | 3 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc.,Fast.(mmol/L), High: Missing (All) | 4 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (All) | 2 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 4 (BL) to 3 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 1 (BL) to 1 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Bilirubin (umol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 3 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (BL) to Gr. 2 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 0 (BL) to 3 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), High: Gr. 0 (BL) to 0 | 5 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGPT/ALT (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 0 | 4 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 1 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 1 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Creatinine (umol/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Gr. 1 (BL) to 1 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | SGOT/AST (U/L), High: Gr. 0 (BL) to 0 | 5 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Missing (BL) to Gr. 0 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 0 (BL) to 3 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Missing (BL) to Gr. 0 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Missing (BL) to Gr. 0 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 0 | 4 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), High: Gr. 0 (BL) to 0 | 5 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Bilirubin (umol/L), High: Gr. 0 (BL) to 0 | 5 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), Low: Gr. 1 (BL) to 0 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 0 (BL) to 1 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Amylase (U/L), High: Gr. 0 (BL) to 0 | 5 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), Low: Missing(BL) to Gr 0 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Potassium (mmol/L), Low: Gr. 0 (BL) to 0 | 3 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 2 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Phosphorus (mmol/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 1 (BL) to 1 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Calcium (mmol/L), High: Gr. 1 (BL) to 0 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 0 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 1 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Sodium (mmol/L), High: Gr. 0 (BL) to 0 | 4 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 0 (BL) to 0 | 4 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 1 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Uric Acid (umol/L), High: Gr. 3 (BL) to 3 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Gr. 0 (BL) to 0 | 4 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), High: Missing (All) | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 2 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Blood Gluc.,Fast.(mmol/L), Low: Missing (All) | 4 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 3 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Glucose (mmol/L), Low: Missing (All) | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Albumin (g/L), Low: Grade (Gr.) 1 (BL) to 1 | 1 Participants |
Secondary
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline
Clinical laboratory tests for hematology parameters were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest (worst) severity grade (according to NCI-CTCAE v4.0) at baseline to the highest grade post-baseline. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a medical intervention or a change in concomitant therapy. For a patient with multiple post-baseline abnormalities, the highest (worst) grade for a given lab test is reported. Abs. = absolute count; BL = baseline; WBC = white blood cell count
Time frame: From Baseline until 35 days after the last dose of study drug (up to 29 months)
Population: Safety Population: participants who received at least one dose of any component of the combination treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 3 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 2 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 3 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), High: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 4 (BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 2 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 2(BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), High: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 3 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 2 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 2 (BL) to 2 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), High: Grade (Gr.) 0 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 2 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 3 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 2 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 0 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 2 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 1 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 4 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 4 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 4 (BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), High: Grade (Gr.) 0 (BL) to 0 | 3 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 2 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 2 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 1 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 2(BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 3 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 3 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 2(BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 4 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 4 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 3 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), High: Grade (Gr.) 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 2 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 3 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 2 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 3 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 3 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 3 | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 2 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 3 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 4 (BL) to 4 | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 1 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 0 | 2 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 4 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 1 | 2 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 2 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 4 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 3 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 4 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 4 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 4 (BL) to 4 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 4 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 2 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 4 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 3 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 1 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 2(BL) to 4 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 4 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), High: Grade (Gr.) 0 (BL) to 0 | 3 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), High: Gr. 0 (BL) to 0 | 3 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 3 (BL) to 3 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 2 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 4 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 1 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 0 | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 4 | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), High: Grade (Gr.) 0 (BL) to 0 | 4 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 2 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 1 | 3 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 3 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 1 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 2 (BL) to 2 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 4 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 2 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 3 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), High: Gr. 0 (BL) to 0 | 4 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 2(BL) to 4 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 0 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 4 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 2 | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 4 (BL) to 4 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 4 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 3 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 3 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 4 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 1 | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), High: Gr. 0 (BL) to 0 | 4 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 0 | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 4 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 4 | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 2 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 2 | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 4 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 3 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 4 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 4 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 4 | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 2 | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 2 | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 4 (BL) to 4 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 4 | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), High: Grade (Gr.) 0 (BL) to 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 1 | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 0 | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 4 | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 2 | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 2(BL) to 4 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), High: Gr. 0 (BL) to 0 | 2 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 3 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 4 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 0 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 4 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 2 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 2 | 2 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 3 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 3 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 4 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 1 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 4 | 2 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 1 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 0 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 2 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 2 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), High: Grade (Gr.) 0 (BL) to 0 | 4 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 3 | 2 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 4 | 2 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 3 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 4 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 2(BL) to 4 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 4 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 2 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 4 (BL) to 4 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 1 | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), High: Gr. 0 (BL) to 0 | 4 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), High: Gr. 0 (BL) to 0 | 4 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 1 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), High: Gr. 0 (BL) to 0 | 5 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 2 (BL) to 3 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), High: Grade (Gr.) 0 (BL) to 0 | 5 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 3 (BL) to 3 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 2(BL) to 4 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), High: Gr. 0 (BL) to 0 | 5 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 0 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 4 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 0 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 1 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 2 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 3 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 1 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 4 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 4 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 0 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 2 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 1 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 1 | 2 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 4 (BL) to 4 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 3 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 1 (BL) to 0 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 1 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 4 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 2 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 0 | 2 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 4 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 2 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 2 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 3 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 3 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | WBC (10^9/L), Low: Gr. 0 (BL) to 4 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 1 (BL) to 4 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 0 | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Platelets (10^9/L), Low: Gr. 0 (BL) to 1 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 0 (BL) to 0 | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 2 | 2 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline | Hemoglobin (g/L), Low: Gr. 1 (BL) to 3 | 0 Participants |
Secondary
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints
Single, resting, 12-lead ECG recordings were to be obtained after the participant had been resting in a supine position for at least 10 minutes. Any morphologic waveform changes or other ECG abnormalities were to be documented and clinical significance was determined based on the presence of symptoms, per the investigator's judgment. If the ECG assessment was missing at baseline then it was recorded as Missing. The ECG results assessments are presented as the shift from baseline to post-baseline assessments at each timepoint. BL = baseline; Cyc1, D1 = Induction Cycle 1 Day 1; Cyc4, D1 = Induction Cycle 4 Day 1; CS = Clinically Significant; EOI = End of Induction Treatment - Completion/Discontinuation; EOM = End of Maintenance Treatment - Completion/Discontinuation; MM1 = Maintenance Month 1; Unsched = Unscheduled Visit
Time frame: Baseline, Induction Cycle 1 Day 1 and Cycle 4 Day 1, End of Induction (up to 6 cycles; 1 cycle is 28 days); Every 2 months during maintenance treatment from Months 1-23; End of Maintenance (up to 24 months); Unscheduled Visits (as clinically indicated)
Population: Safety Population: participants who received at least one dose of any component of the combination treatment. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Abnormal, not CS (BL) to Abnormal, not CS | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4, D1: Normal (BL) to Abnormal, not CS | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4, D1: Normal (BL) to Normal | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Abnormal, not CS (BL) to Normal | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Normal (BL) to Abnormal, not CS | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Normal (BL) to Normal | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Missing (BL) to Normal | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Abnormal, not CS (BL) to Abnormal, CS | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Abnormal, not CS (BL) to Abnormal, not CS | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Normal (BL) to Abnormal, not CS | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Normal (BL) to Normal | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4, D1: Missing (BL) to Normal | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4,D1: Abnormal, not CS (BL) to Abnormal, not CS | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4, D1: Abnormal, not CS (BL) to Normal | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Abnormal, not CS (BL) to Normal | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Normal (BL) to Abnormal, not CS | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Normal (BL) to Normal | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1,D1: Abnormal, not CS (BL) to Abnormal, not CS | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Normal (BL) to Normal | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Normal (BL) to Abnormal, not CS | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Abnormal, not CS (BL) to Abnormal, not CS | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Missing (BL) to Normal | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Abnormal, not CS (BL) to Abnormal, not CS | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Missing (BL) to Normal | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Abnormal, not CS (BL) to Normal | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Normal (BL) to Normal | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Normal (BL) to Normal | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Normal (BL) to Abnormal, not CS | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1,D1: Abnormal, not CS (BL) to Abnormal, not CS | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Normal (BL) to Abnormal, not CS | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Abnormal, not CS (BL) to Normal | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Normal (BL) to Abnormal, not CS | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Normal (BL) to Normal | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1,D1: Abnormal, not CS (BL) to Abnormal, not CS | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Missing (BL) to Normal | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Abnormal, not CS (BL) to Abnormal, not CS | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Normal (BL) to Normal | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Normal (BL) to Abnormal, not CS | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Normal (BL) to Abnormal, not CS | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Normal (BL) to Normal | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1,D1: Abnormal, not CS (BL) to Abnormal, not CS | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Normal (BL) to Normal | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Normal (BL) to Abnormal, not CS | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Missing (BL) to Normal | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Abnormal, not CS (BL) to Abnormal, not CS | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Abnormal, not CS (BL) to Normal | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Normal (BL) to Abnormal, not CS | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1,D1: Abnormal, not CS (BL) to Abnormal, not CS | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4, D1: Normal (BL) to Normal | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4, D1: Normal (BL) to Abnormal, not CS | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4, D1: Abnormal, not CS (BL) to Normal | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4,D1: Abnormal, not CS (BL) to Abnormal, not CS | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4, D1: Missing (BL) to Normal | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Normal (BL) to Normal | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Abnormal, not CS (BL) to Abnormal, CS | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Normal (BL) to Abnormal, not CS | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Abnormal, not CS (BL) to Abnormal, not CS | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Missing (BL) to Normal | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | MM7: Missing (BL) to Abnormal, not CS | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | MM9: Missing (BL) to Abnormal, not CS | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | MM11: Missing (BL) to Abnormal, not CS | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | MM13: Missing (BL) to Abnormal, not CS | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | MM15: Missing (BL) to Abnormal, not CS | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | MM17: Missing (BL) to Abnormal, not CS | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | MM19: Missing (BL) to Abnormal, not CS | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | MM21: Missing (BL) to Abnormal, not CS | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | MM23: Missing (BL) to Abnormal, not CS | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOM: Normal (BL) to Normal | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOM: Missing (BL) to Abnormal, not CS | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Normal (BL) to Normal | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Normal (BL) to Normal | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Normal (BL) to Abnormal, not CS | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Abnormal, not CS (BL) to Normal | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Abnormal, not CS (BL) to Abnormal, not CS | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Abnormal, not CS (BL) to Normal | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Normal (BL) to Abnormal, not CS | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Normal (BL) to Normal | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Missing (BL) to Normal | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1,D1: Abnormal, not CS (BL) to Abnormal, not CS | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Normal (BL) to Abnormal, not CS | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4, D1: Normal (BL) to Normal | 2 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Abnormal, not CS (BL) to Normal | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Abnormal, not CS (BL) to Normal | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOM: Normal (BL) to Normal | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Normal (BL) to Normal | 3 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOM: Missing (BL) to Abnormal, not CS | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4, D1: Missing (BL) to Normal | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4,D1: Abnormal, not CS (BL) to Abnormal, not CS | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Normal (BL) to Normal | 4 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Normal (BL) to Abnormal, not CS | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4, D1: Normal (BL) to Abnormal, not CS | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Abnormal, not CS (BL) to Abnormal, CS | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4, D1: Abnormal, not CS (BL) to Normal | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Abnormal, not CS (BL) to Abnormal, not CS | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Abnormal, not CS (BL) to Abnormal, not CS | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Abnormal, not CS (BL) to Normal | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4, D1: Normal (BL) to Abnormal, not CS | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Normal (BL) to Normal | 2 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4, D1: Normal (BL) to Normal | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4, D1: Missing (BL) to Normal | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Abnormal, not CS (BL) to Abnormal, not CS | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Missing (BL) to Normal | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | MM1: Normal (BL) to Normal | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | MM1: Abnormal, not CS (BL) to Abnormal, not CS | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | MM3: Abnormal, not CS (BL) to Normal | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | MM5: Abnormal, not CS (BL) to Normal | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Normal (BL) to Normal | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4, D1: Abnormal, not CS (BL) to Normal | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Abnormal, not CS (BL) to Abnormal, not CS | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc4,D1: Abnormal, not CS (BL) to Abnormal, not CS | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Normal (BL) to Abnormal, not CS | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Normal (BL) to Normal | 2 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1, D1: Normal (BL) to Abnormal, not CS | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Abnormal, not CS (BL) to Abnormal, CS | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Unsched: Abnormal, not CS (BL) to Normal | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | Cyc1,D1: Abnormal, not CS (BL) to Abnormal, not CS | 2 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints | EOI: Normal (BL) to Abnormal, not CS | 0 Participants |
Secondary
Number of Participants With a Dose-Limiting Toxicity
A dose-limiting toxicity (DLT) was defined as at least one of the following events occurring during Cycle 1 (or first 2 cycles in the bridging FL cohort) of treatment and assessed by the investigator as not clearly related to the underlying disease: Any Grade 5 adverse event (AE; severity graded per NCI-CTCAE v4.0) unless due to the underlying malignancy or extraneous causes; AE of any grade that leads to a delay of more than (\>)14 days in the start of the next treatment cycle; Grade 3 or 4 non-hematologic AEs (with exceptions); Lab results suggestive of potential drug-induced liver injury (according to Hy's law); Grade 3 or 4 neutropenia in the presence of sustained fever of \>38 C (lasting \>5 days) or a documented infection; Grade 4 neutropenia or thrombocytopenia lasting \>7 days; Grade 3 or 4 thrombocytopenia if associated with Grade ≥3 bleeding; Other toxicities considered clinically relevant and related to study treatment as determined by the investigator and medical monitor.
Time frame: Cycles 1, 2 (1 cycle is 28 days)
Population: Safety Population: participants who received at least one dose of any study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants With a Dose-Limiting Toxicity | Thrombocytopenia | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants With a Dose-Limiting Toxicity | Any DLT | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants With a Dose-Limiting Toxicity | Any DLT | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants With a Dose-Limiting Toxicity | Thrombocytopenia | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Number of Participants With a Dose-Limiting Toxicity | Any DLT | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Number of Participants With a Dose-Limiting Toxicity | Thrombocytopenia | 2 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Number of Participants With a Dose-Limiting Toxicity | Any DLT | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Number of Participants With a Dose-Limiting Toxicity | Thrombocytopenia | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Number of Participants With a Dose-Limiting Toxicity | Any DLT | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Number of Participants With a Dose-Limiting Toxicity | Thrombocytopenia | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants With a Dose-Limiting Toxicity | Any DLT | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Number of Participants With a Dose-Limiting Toxicity | Thrombocytopenia | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants With a Dose-Limiting Toxicity | Any DLT | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants With a Dose-Limiting Toxicity | Thrombocytopenia | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants With a Dose-Limiting Toxicity | Thrombocytopenia | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Number of Participants With a Dose-Limiting Toxicity | Any DLT | 1 Participants |
Secondary
Percentage of Participants With Best Response of Complete Response or Partial Response During the Study, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria
The investigator was to evaluate responses throughout the study using the Lugano 2014 response criteria for malignant lymphoma for a CT-based best response of a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a ≥50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by \>50% in length. Participants without a post-baseline tumor assessment were to be considered non-responders.
Time frame: Baseline, Cycle 2, end of induction (up to 6 cycles; 1 cycle is 28 days), every 2 months (FL) until end of maintenance or at 4 months (DLBCL) of consolidation treatment, and then every 6 months during follow-up until disease progression (up to 3.5 years)
Population: The study plan was for this efficacy analysis to be based on responses in participants enrolled during the expansion phase (Phase 2), but it was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Phase 1).
Secondary
Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria
The investigator evaluated responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a computed tomography (CT)-based complete response (CR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 centimetres in the longest transverse diameter of a lesion \[LDi\]; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders.
Time frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
Population: ITT Population: all enrolled participants; exploratory analysis of the dose escalation phase (Phase 1). The study plan was for efficacy analyses to be based on responses in participants enrolled during the expansion phase (Phase 2), but it was not opened (i.e., no enrollment) and the study was terminated early.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria | 0 Percentage of participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria | 33.3 Percentage of participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria | 0 Percentage of participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria | 0 Percentage of participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria | 0 Percentage of participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria | 0 Percentage of participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria | 0 Percentage of participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria | 20.0 Percentage of participants |
Secondary
Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Lugano 2014 Criteria
The investigator evaluated responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based complete response (CR), which required a complete metabolic response with a score of 1, 2, or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to \[≤\] mediastinum; 3 = uptake greater than \[\>\] mediastinum and ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly \> liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma). The CR criteria for participants with bone marrow involvement at screening required no evidence of FDG-avid disease in the marrow. PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were considered non-responders.
Time frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
Population: ITT Population: all enrolled participants; exploratory analysis of the dose escalation phase (Phase 1). The study plan was for efficacy analyses to be based on responses in participants enrolled during the expansion phase (Phase 2), but it was not opened (i.e., no enrollment) and the study was terminated early.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Lugano 2014 Criteria | 0 Percentage of participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Lugano 2014 Criteria | 33.3 Percentage of participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Lugano 2014 Criteria | 0 Percentage of participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Lugano 2014 Criteria | 0 Percentage of participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Lugano 2014 Criteria | 0 Percentage of participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Lugano 2014 Criteria | 50.0 Percentage of participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Lugano 2014 Criteria | 0 Percentage of participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Lugano 2014 Criteria | 40.0 Percentage of participants |
Secondary
Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria
The investigator evaluated responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based complete response (CR), which required a complete metabolic response with a score of 1, 2, or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to \[≤\] mediastinum; 3 = uptake greater than \[\>\] mediastinum and ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly \> liver and/or new lesions). The CR criteria were slightly modified to require normal bone marrow by morphology (if indeterminate, immunohistochemistry negative). PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were considered non-responders.
Time frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
Population: ITT Population: all enrolled participants; exploratory analysis of the dose escalation phase (Phase 1). The study plan was for efficacy analyses to be based on responses in participants enrolled during the expansion phase (Phase 2), but it was not opened (i.e., no enrollment) and the study was terminated early.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria | 0 Percentage of participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria | 33.3 Percentage of participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria | 0 Percentage of participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria | 0 Percentage of participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria | 0 Percentage of participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria | 50.0 Percentage of participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria | 0 Percentage of participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria | 40.0 Percentage of participants |
Secondary
Percentage of Participants With Complete Response at the End of Induction, Determined by the IRC on the Basis of CT Scans Alone Using Lugano 2014 Criteria
The IRC was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a computed tomography (CT)-based complete response (CR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 centimetres in the longest transverse diameter of a lesion \[LDi\]; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders.
Time frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
Population: The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Phase 2), but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Phase 1).
Secondary
Percentage of Participants With Objective Response at the End of Induction, Determined by an IRC on the Basis of CT Scans Alone Using Lugano 2014 Criteria
The IRC was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a ≥50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by \>50% in length. Participants without a post-baseline tumor assessment were to be considered non-responders.
Time frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
Population: The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Phase 2), but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Phase 1).
Secondary
Percentage of Participants With Objective Response at the End of Induction, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria
The investigator was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a ≥50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by \>50% in length. Participants without a post-baseline tumor assessment were to be considered non-responders.
Time frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
Population: The study plan was for this efficacy analysis to be based on responses in participants enrolled during the expansion phase (Phase 2), but it was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Phase 1).
Secondary
Percentage of Participants With Objective Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Lugano 2014 Criteria
The investigator was to evaluate responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based objective response: either a complete (CR) or partial response (PR). A CR required a complete metabolic response with a score of 1, 2, or 3 on the PET 5-point scale (5PS) for 18-fluorodeoxyglucose (FDG) uptake (scores range from 1 \[no uptake above background\] to 5 \[uptake markedly higher than liver and/or new lesions\]), with or without a residual mass in lymph nodes and extralymphatic sites; and a PR required a partial metabolic response with a score of 4 or 5 on the 5PS with reduced 18-FDG uptake compared with baseline and residual mass(es) of any size. For bone marrow involvement, the CR criteria required no evidence of FDG-avid disease, and the PR criteria required residual uptake higher than in normal marrow but reduced compared with baseline. Participants without a post-baseline tumor assessment were to be considered non-responders.
Time frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
Population: The study plan was for this efficacy analysis to be based on responses in participants enrolled during the expansion phase (Phase 2), but it was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Phase 1).
Secondary
Percentage of Participants With Objective Response at the End of Induction, Determined by the IRC on the Basis of PET-CT Scans Using Lugano 2014 Criteria
The IRC was to evaluate responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based objective response: either a complete (CR) or partial response (PR). A CR required a complete metabolic response with a score of 1, 2, or 3 on the PET 5-point scale (5PS) for 18-fluorodeoxyglucose (FDG) uptake (scores range from 1 \[no uptake above background\] to 5 \[uptake markedly higher than liver and/or new lesions\]), with or without a residual mass in lymph nodes and extralymphatic sites; and a PR required a partial metabolic response with a score of 4 or 5 on the 5PS with reduced 18-FDG uptake compared with baseline and residual mass(es) of any size. For bone marrow involvement, the CR criteria required no evidence of FDG-avid disease, and the PR criteria required residual uptake higher than in normal marrow but reduced compared with baseline. Participants without a post-baseline tumor assessment were to be considered non-responders.
Time frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
Population: The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Phase 2), but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Phase 1).
Secondary
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab)
The concentration of idasanutlin was determined using a validated assay. The duplication of the predose timepoint (0 hours) on Day 5 as an additional 24-hour timepoint on Day 5 was done in order to conduct pharmacokinetics analysis via non-compartmental analysis, and to derive idasanutlin exposure estimates up to the 24-hour post Day 5 dosing.
Time frame: Predose (0 hours) and 6 hours postdose on Day 1 of Cycles 1, 2, and 4; Predose (0 hours) and 2, 4, 6, and 24 hours postdose on Day 5 of Cycles 1 and 2; Predose (0 hours) and 6 and 24 hours postdose on Cycle 4, Day 5 (1 cycle is 28 days)
Population: Pharmacokinetics Evaluable Population: all participants who received at least one dose of study drug. For this analysis, FL and DLBCL participants are grouped by idasanutlin dose and combination drug (obinutuzumab or rituximab). The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 2, Day 1: 0 hours | 0 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 0 |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 2, Day 1: 6 hours | 1660 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 33.1 |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 24 hours | 1150 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 19.9 |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 1: 0 hours | 0 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 0 |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 1: 6 hours | 1540 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 21.6 |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 6 hours | 1730 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 15.5 |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 4 hours | 1670 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 17.5 |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 2 hours | 1230 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 20.8 |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 0 hours | 1150 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 19.9 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 1: 0 hours | 0 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 0 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 4 hours | 4360 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 67.6 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 4, Day 1: 0 hours | 0 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 0 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 4, Day 1: 6 hours | 2730 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 9.9 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 4, Day 5: 0 hours | 2600 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 25.6 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 1: 6 hours | 2210 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 42.4 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 0 hours | 2150 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 46.4 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 2 hours | 3570 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 68.4 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 6 hours | 4220 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 94.8 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 24 hours | 2150 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 46.4 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 2, Day 1: 0 hours | 0 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 0 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 2, Day 1: 6 hours | 2480 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 51.5 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 2, Day 5: 0 hours | 2380 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 27.2 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 2, Day 5: 2 hours | 4050 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 54.9 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 2, Day 5: 4 hours | 4200 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 38.2 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 2, Day 5: 6 hours | 4010 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 31.6 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 2, Day 5: 24 hours | 2380 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 27.2 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 4, Day 5: 6 hours | 5210 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 19.5 |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 4, Day 5: 24 hours | 2600 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 25.6 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 4 hours | 7930 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 15.5 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 1: 0 hours | 0 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 0 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 6 hours | 7310 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 13.6 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 0 hours | 4120 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 27.3 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 1: 6 hours | 5540 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 21.5 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 2 hours | 7850 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 23 |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 24 hours | 4120 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 27.3 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 2 hours | 2970 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 53.2 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 4 hours | 2910 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 73.2 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 2, Day 1: 0 hours | 0 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 0 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 6 hours | 2820 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 68.7 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 24 hours | 1660 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 77.9 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 1: 6 hours | 2130 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 91.3 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 2, Day 1: 6 hours | 1260 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 49.8 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 1: 0 hours | 0 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 0 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 0 hours | 1660 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 77.9 |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 2, Day 5: 0 hours | 2400 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 67 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 1: 0 hours | 0 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 0 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 4 hours | 5910 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 54.6 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 24 hours | 2920 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 56.8 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 0 hours | 2920 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 56.8 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 1: 6 hours | 2980 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 49.9 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 6 hours | 5200 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 49.8 |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) | Cycle 1, Day 5: 2 hours | 4970 nanograms per millilitre (ng/mL) | Geometric Coefficient of Variation 45.7 |
Secondary
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0)
The adverse event (AE) severity grading scale for the NCI CTCAE v4.0 was used for assessing AE severity. Any AEs that were not specifically listed in the NCI CTCAE, v4.0 were graded per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. The terms severe and serious are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.
Time frame: From first dose until 90 days after the last dose of study drug treatment (up to 31 months)
Population: Safety Population: participants who received at least one dose of any component of the combination treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Grade 5 AE | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related AE Leading to Treatment Discontinuation | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Grade 3-5 AE | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Dose Reductions | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Study Discontinuation | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Any AE | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Serious AE | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Any Adverse Event (AE) | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Any AE | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Dose Interruptions | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Serious AE | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Serious AE | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Grade 3-5 AE | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Grade 3-5 AE | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to any Study Treatment Discontinuation | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Grade 3-5 AE | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Serious AE | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Any AE | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Grade 3-5 AE | 3 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Dose Interruptions | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Dose Reductions | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Grade 3-5 AE | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Grade 5 AE | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related AE Leading to Treatment Discontinuation | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Any AE | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Serious AE | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Grade 3-5 AE | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Study Discontinuation | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Any Adverse Event (AE) | 3 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Any AE | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Serious AE | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Serious AE | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Serious AE | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Grade 3-5 AE | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Any AE | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to any Study Treatment Discontinuation | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Any AE | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Any Adverse Event (AE) | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Grade 5 AE | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Grade 3-5 AE | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Serious AE | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to any Study Treatment Discontinuation | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Dose Reductions | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Dose Interruptions | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Study Discontinuation | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Any AE | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Grade 3-5 AE | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Serious AE | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Grade 3-5 AE | 2 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Serious AE | 1 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Any AE | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Grade 3-5 AE | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Serious AE | 0 Participants |
| DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related AE Leading to Treatment Discontinuation | 2 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Any AE | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Dose Reductions | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Any AE | 2 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Grade 3-5 AE | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Dose Interruptions | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Serious AE | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Study Discontinuation | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related AE Leading to Treatment Discontinuation | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to any Study Treatment Discontinuation | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Serious AE | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Any Adverse Event (AE) | 3 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Grade 3-5 AE | 1 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Grade 3-5 AE | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Any AE | 2 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Grade 5 AE | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Serious AE | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Serious AE | 0 Participants |
| DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Grade 3-5 AE | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Serious AE | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Grade 3-5 AE | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Grade 5 AE | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related AE Leading to Treatment Discontinuation | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Any AE | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Any AE | 4 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to any Study Treatment Discontinuation | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Any Adverse Event (AE) | 4 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Grade 3-5 AE | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Dose Reductions | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Serious AE | 2 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Serious AE | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Study Discontinuation | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Grade 3-5 AE | 3 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Any AE | 1 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Serious AE | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Grade 3-5 AE | 0 Participants |
| DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Dose Interruptions | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Grade 3-5 AE | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Dose Interruptions | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Serious AE | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Any AE | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to any Study Treatment Discontinuation | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Grade 5 AE | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Dose Reductions | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Any AE | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Any Adverse Event (AE) | 2 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related AE Leading to Treatment Discontinuation | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Any AE | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Grade 3-5 AE | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Grade 3-5 AE | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Serious AE | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Serious AE | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Serious AE | 1 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Study Discontinuation | 0 Participants |
| FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Grade 3-5 AE | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Serious AE | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Serious AE | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Study Discontinuation | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Any AE | 4 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Serious AE | 1 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Grade 3-5 AE | 3 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Serious AE | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Grade 3-5 AE | 3 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Any AE | 3 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Grade 3-5 AE | 2 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Grade 5 AE | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Dose Interruptions | 3 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Any AE | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Any Adverse Event (AE) | 4 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Grade 3-5 AE | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related AE Leading to Treatment Discontinuation | 2 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Dose Reductions | 0 Participants |
| FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to any Study Treatment Discontinuation | 2 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Serious AE | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Grade 3-5 AE | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Grade 3-5 AE | 4 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related AE Leading to Treatment Discontinuation | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Serious AE | 2 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Grade 5 AE | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Any AE | 5 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Serious AE | 2 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Grade 3-5 AE | 4 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Idasanutlin - Any AE | 5 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Study Discontinuation | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Dose Reductions | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to any Study Treatment Discontinuation | 2 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | AE Leading to Dose Interruptions | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Any Adverse Event (AE) | 5 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Rituximab - Any AE | 0 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Serious AE | 1 Participants |
| FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg | Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) | Related to Obinutuzumab - Grade 3-5 AE | 3 Participants |
Secondary
Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints
Time frame: Pre-infusion (0 hour) and 0.5 hours after end of obinutuzumab infusion on Day 1 of Cycles 1, 2, 4, and 6
Population: Pharmacokinetics Evaluable Population: all participants who received at least one dose of study drug. This analysis only includes FL and DLBCL participants who received obinutuzumab. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints | Cycle 4, Day 1: 0 hours | 346 micrograms per millilitre (μg/mL) | Geometric Coefficient of Variation 46.1 |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints | Cycle 1, Day 1: 0 hours | 0 micrograms per millilitre (μg/mL) | Geometric Coefficient of Variation 0 |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints | Cycle 1, Day 1: 0.5 hours | 397 micrograms per millilitre (μg/mL) | Geometric Coefficient of Variation 32.9 |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints | Cycle 2, Day 1: 0 hours | 325 micrograms per millilitre (μg/mL) | Geometric Coefficient of Variation 59.8 |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints | Cycle 2, Day 1: 0.5 hours | 703 micrograms per millilitre (μg/mL) | Geometric Coefficient of Variation 40.2 |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints | Cycle 4, Day 1: 0.5 hours | 685 micrograms per millilitre (μg/mL) | Geometric Coefficient of Variation 38.5 |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints | Cycle 6, Day 1: 0 hours | 303 micrograms per millilitre (μg/mL) | Geometric Coefficient of Variation 49.5 |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints | Cycle 6, Day 1: 0.5 hours | 639 micrograms per millilitre (μg/mL) | Geometric Coefficient of Variation 34.2 |
Secondary
Serum Rituximab Concentrations in DLBCL Participants at Nominal Sampling Timepoints
Time frame: Pre-infusion (0 hours) at Cycle 1, Day 1 and Cycle 2, Day 1; Post-infusion 0.5 hours at Cycle 1, Day 1 (1 cycle is 28 days)
Population: Pharmacokinetics Evaluable Population: all participants who received at least one dose of study drug. This analysis only includes DLBCL participants who received rituximab. The number analyzed includes participants who were evaluable at each timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Serum Rituximab Concentrations in DLBCL Participants at Nominal Sampling Timepoints | Cycle 1, Day 1: 0 hours | 0 micrograms per millilitre (μg/mL) | Geometric Coefficient of Variation 0 |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Serum Rituximab Concentrations in DLBCL Participants at Nominal Sampling Timepoints | Cycle 1, Day 1: 0.5 hours | 197 micrograms per millilitre (μg/mL) | Geometric Coefficient of Variation 14.1 |
| DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg | Serum Rituximab Concentrations in DLBCL Participants at Nominal Sampling Timepoints | Cycle 2, Day 1: 0 hours | 37.9 micrograms per millilitre (μg/mL) | Geometric Coefficient of Variation 58.1 |