A Study of Idasanutlin in Combination With Obinutuzumab i... | NCT02624986 | Trialant
NCT02624986
Sponsor
Hoffmann-La Roche
Status
Terminated
Last Update Posted
May 18, 2020Actual
Enrollment
25Actual
Phase
Phase 1Phase 2
Conditions
Non-Hodgkin's Lymphoma
Interventions
Idasanutlin
Obinutuzumab
Rituximab
Countries
United States
Australia
Germany
New Zealand
South Korea
Protocol Section
Identification Module
NCT ID
NCT02624986
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
BH29812
Secondary IDs
ID
Type
Description
Link
2015-002100-83
EudraCT Number
Brief Title
A Study of Idasanutlin in Combination With Obinutuzumab in Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and in Combination With Rituximab in R/R Diffuse Large B-Cell Lymphoma (DLBCL) Participants
Official Title
A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination With Idasanutlin in Patients With Relapsed or Refractory Follicular Lymphoma and Obinutuzumab or Rituximab in Combination With Idasanutlin in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Apr 2020
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor's decision to terminate the study after Phase 1; will not proceed with Phase 2.
Expanded Access Info
No
Start Date
Dec 23, 2015Actual
Primary Completion Date
May 20, 2019Actual
Completion Date
May 20, 2019Actual
First Submitted Date
Dec 1, 2015
First Submission Date that Met QC Criteria
Dec 4, 2015
First Posted Date
Dec 9, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 16, 2020
Results First Submitted that Met QC Criteria
Apr 16, 2020
Results First Posted Date
Apr 29, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 29, 2020
Last Update Posted Date
May 18, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Participants with 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).
Participants with 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).
Participants with 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).
Participants with 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).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Idasanutlin
Drug
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.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trials
Hoffmann-La Roche
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Mayo Clinic Arizona
Phoenix
Arizona
85259
United States
University of Colorado
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
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 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).
Participants with 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).
Participants with 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).
Participants with 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).
Participants with 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).
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.
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.
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.
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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.
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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.
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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.
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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.
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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.
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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.
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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.
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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.
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)
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.
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)
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
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)
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.
From first dose until 90 days after the last dose of study drug treatment (up to 31 months)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
From Baseline until 35 days after the last dose of study drug (up to 29 months)
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
From Baseline until 35 days after the last dose of study drug (up to 29 months)
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).
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).
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).
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).
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).
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).
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).
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Received Any Study Treatment
Safety Population
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COMPLETED
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FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0002 subjects
FG0013 subjects
FG0022 subjects
FG0033 subjects
FG0044 subjects
FG0052 subjects
FG0064 subjects
FG0075 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
Study Terminated by Sponsor
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Progressive Disease
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Intent-to-Treat (ITT) Population: all enrolled participants.
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).
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).
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).
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).
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).
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).
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).
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).
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002
BG0013
BG0022
BG0033
BG0044
BG0052
BG0064
BG0075
BG00825
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00062.5± 6.4
BG00170.7± 15.2
BG00255.5± 10.6
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With 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.
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).
Posted
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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).
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).
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).
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).
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).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
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.
Safety Population: participants who received at least one dose of any study drug.
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).
OG001
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.
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.
Posted
Number
90% Confidence Interval
Percentage of participants
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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).
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.
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.
Posted
Number
90% Confidence Interval
Percentage of participants
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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.
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).
Posted
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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).
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.
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.
Posted
Number
90% Confidence Interval
Percentage of participants
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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).
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.
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).
Posted
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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).
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.
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).
Posted
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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).
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.
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).
Posted
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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).
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.
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).
Posted
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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).
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.
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).
Posted
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)
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.
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.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per millilitre (ng/mL)
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)
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) 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).
Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints
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.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms per millilitre (μg/mL)
Pre-infusion (0 hour) and 0.5 hours after end of obinutuzumab infusion on Day 1 of Cycles 1, 2, 4, and 6
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma received induction treatment with idasanutlin 100 milligrams (mg), 150 mg, or 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Units
Counts
Participants
OG000
Secondary
Serum Rituximab Concentrations in DLBCL Participants at Nominal Sampling Timepoints
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.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms per millilitre (μg/mL)
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)
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) received induction treatment with idasanutlin 150 mg or 200 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).
Units
Counts
Participants
OG000
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.
Safety Population: participants who received at least one dose of any component of the combination treatment.
Posted
Count of Participants
Participants
From first dose until 90 days after the last dose of study drug treatment (up to 31 months)
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).
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
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.
Posted
Mean
Standard Deviation
millimeters of mercury (mmHg)
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)
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).
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).
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
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.
Posted
Mean
Standard Deviation
millimeters of mercury (mmHg)
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)
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).
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).
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
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.
Posted
Mean
Standard Deviation
beats per minute
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)
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).
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).
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
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.
Posted
Mean
Standard Deviation
breaths per minute
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)
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).
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).
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
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.
Posted
Mean
Standard Deviation
degrees Celsius (C)
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)
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).
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).
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
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.
Posted
Count of Participants
Participants
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)
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).
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
Safety Population: participants who received at least one dose of any component of the combination treatment.
Posted
Count of Participants
Participants
From Baseline until 35 days after the last dose of study drug (up to 29 months)
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).
OG001
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
Safety Population: participants who received at least one dose of any component of the combination treatment.
Posted
Count of Participants
Participants
From Baseline until 35 days after the last dose of study drug (up to 29 months)
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).
Time Frame
From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment
Description
Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
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).
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).
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).
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).
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).
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).
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).
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).
1
5
2
5
5
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected3 at risk
EG004
Pancytopenia
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected2 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Peripheral swelling
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected2 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected4 at risk
EG0052 events1 affected2 at risk
EG0063 events3 affected4 at risk
EG0073 events2 affected5 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0013 events2 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0023 events2 affected2 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0012 events2 affected3 at risk
EG0022 events2 affected2 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0022 events1 affected2 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events1 affected1 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected2 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Skin infection
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Anal inflammation
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected2 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Chest pain
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Fatigue
General disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected2 at risk
EG003
Oedema
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Oedema peripheral
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Pain
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Pyrexia
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Sinusitis
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Blood albumin decreased
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Haemophilus test positive
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Lipase increased
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected2 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Headache
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Trigeminal neuralgia
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Depression
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Hot flush
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected2 at risk
EG003
Due to the overall modest benefit achieved with the maximum tolerated dose during the dose escalation phase, the Sponsor decided not to open the expansion phase and terminated the study. Consequently, some planned analyses could not be performed.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
Units
Counts
Participants
OG0002
OG0013
OG0022
OG0033
OG0044
OG0052
OG0064
OG0075
Title
Denominators
Categories
Title
Measurements
OG0000(0.00 to 77.64)
OG00133.3(1.70 to 86.46)
OG0020(0.00 to 77.64)
OG0030(0.00 to 63.16)
OG0040(0.00 to 52.71)
OG00550.0(2.53 to 97.47)
OG0060(0.00 to 52.71)
OG00740.0(7.64 to 81.07)
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
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).
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).
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).
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).
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).
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).
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).
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).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) 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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
Units
Counts
Participants
OG0001
OG0013
OG0022
OG0033
OG0044
OG0052
OG0064
OG0075
Title
Denominators
Categories
Baseline (BL) - Value at Visit
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0044
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0075
Title
Measurements
OG000176.0± NAStandard deviation could not be calculated from data for a single participant.
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).
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).
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).
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).
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).
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).
Units
Counts
Participants
OG0001
OG0013
OG0022
OG0033
OG0044
OG0052
OG0064
OG0075
Title
Denominators
Categories
Baseline (BL) - Value at Visit
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0044
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0075
Title
Measurements
OG000100.0± NAStandard deviation could not be calculated from data for a single participant.
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).
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).
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).
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).
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).
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).
Units
Counts
Participants
OG0001
OG0013
OG0022
OG0033
OG0044
OG0052
OG0064
OG0075
Title
Denominators
Categories
Baseline (BL) - Value at Visit
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0044
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0075
Title
Measurements
OG00073.0± NAStandard deviation could not be calculated from data for a single participant.
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).
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).
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).
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).
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).
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).
Units
Counts
Participants
OG0001
OG0013
OG0022
OG0033
OG0044
OG0052
OG0064
OG0075
Title
Denominators
Categories
Baseline (BL) - Value at Visit
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0044
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0075
Title
Measurements
OG00018.0± NAStandard deviation could not be calculated from data for a single participant.
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).
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).
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).
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).
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).
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).
Units
Counts
Participants
OG0001
OG0013
OG0022
OG0033
OG0044
OG0052
OG0064
OG0075
Title
Denominators
Categories
Baseline (BL) - Value at Visit
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0044
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0075
Title
Measurements
OG00036.60± NAStandard deviation could not be calculated from data for a single participant.
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).
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).
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).
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).
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).
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).
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).
Units
Counts
Participants
OG0001
OG0013
OG0022
OG0033
OG0044
OG0052
OG0064
OG0075
Title
Denominators
Categories
Cyc1, D1: Normal (BL) to Normal
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0044
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0075
Title
Measurements
OG0011
OG0021
OG0030
OG004
Cyc1, D1: Normal (BL) to Abnormal, not CS
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Cyc1, D1: Abnormal, not CS (BL) to Normal
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Cyc1,D1: Abnormal, not CS (BL) to Abnormal, not CS
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG003
Cyc4, D1: Normal (BL) to Normal
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cyc4, D1: Normal (BL) to Abnormal, not CS
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cyc4, D1: Abnormal, not CS (BL) to Normal
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cyc4,D1: Abnormal, not CS (BL) to Abnormal, not CS
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cyc4, D1: Missing (BL) to Normal
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EOI: Normal (BL) to Normal
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0031
EOI: Normal (BL) to Abnormal, not CS
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0031
EOI: Abnormal, not CS (BL) to Abnormal, not CS
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0031
EOI: Missing (BL) to Normal
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0031
MM1: Normal (BL) to Normal
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
MM1: Abnormal, not CS (BL) to Abnormal, not CS
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
MM3: Abnormal, not CS (BL) to Normal
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
MM5: Abnormal, not CS (BL) to Normal
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
MM7: Missing (BL) to Abnormal, not CS
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
MM9: Missing (BL) to Abnormal, not CS
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
MM11: Missing (BL) to Abnormal, not CS
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
MM13: Missing (BL) to Abnormal, not CS
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
MM15: Missing (BL) to Abnormal, not CS
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
MM17: Missing (BL) to Abnormal, not CS
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
MM19: Missing (BL) to Abnormal, not CS
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
MM21: Missing (BL) to Abnormal, not CS
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
MM23: Missing (BL) to Abnormal, not CS
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EOM: Normal (BL) to Normal
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EOM: Missing (BL) to Abnormal, not CS
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Unsched: Normal (BL) to Normal
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Unsched: Normal (BL) to Abnormal, not CS
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Unsched: Abnormal, not CS (BL) to Normal
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Unsched: Abnormal, not CS (BL) to Abnormal, not CS
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).
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).
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).
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).
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).
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).
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).
Units
Counts
Participants
OG0001
OG0013
OG0022
OG0033
OG0044
OG0052
OG0064
OG0075
Title
Denominators
Categories
Hemoglobin (g/L), High: Grade (Gr.) 0 (BL) to 0
Title
Measurements
OG0001
OG0013
OG0022
OG0033
OG0044
OG0052
OG0064
OG0075
Hemoglobin (g/L), Low: Gr. 0 (BL) to 0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin (g/L), Low: Gr. 0 (BL) to 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin (g/L), Low: Gr. 0 (BL) to 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin (g/L), Low: Gr. 1 (BL) to 1
Title
Measurements
OG0000
OG0012
OG0020
OG003
Hemoglobin (g/L), Low: Gr. 1 (BL) to 2
Title
Measurements
OG0000
OG0011
OG0021
OG003
Hemoglobin (g/L), Low: Gr. 1 (BL) to 3
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hemoglobin (g/L), Low: Gr. 2 (BL) to 2
Title
Measurements
OG0001
OG0010
OG0020
OG003
Hemoglobin (g/L), Low: Gr. 2 (BL) to 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin (g/L), Low: Gr. 3 (BL) to 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes Abs. (10^9/L), High: Gr. 0 (BL) to 0
Title
Measurements
OG0001
OG0013
OG0022
OG003
Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 2
Title
Measurements
OG0001
OG0010
OG0020
OG003
Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 3
Title
Measurements
OG0000
OG0010
OG0021
OG003
Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 3
Title
Measurements
OG0000
OG0010
OG0021
OG003
Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 4
Title
Measurements
OG0000
OG0011
OG0020
OG003
Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 2
Title
Measurements
OG0000
OG0011
OG0020
OG003
Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 4
Title
Measurements
OG0000
OG0011
OG0020
OG003
Lymphocytes Abs. (10^9/L), Low: Gr. 4 (BL) to 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 0
Title
Measurements
OG0000
OG0012
OG0020
OG003
Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 2
Title
Measurements
OG0000
OG0011
OG0020
OG003
Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 3
Title
Measurements
OG0001
OG0010
OG0020
OG003
Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 4
Title
Measurements
OG0000
OG0010
OG0022
OG003
Neutrophils,Total Abs (10^9/L),Low: Gr. 2(BL) to 4
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).
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).
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).
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).
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).
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).
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).
Units
Counts
Participants
OG0001
OG0013
OG0022
OG0033
OG0044
OG0052
OG0064
OG0075
Title
Denominators
Categories
Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 0
Title
Measurements
OG0001
OG0013
OG0022
OG0031
OG0042
OG0052
OG0064
OG0073
Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Albumin (g/L), Low: Grade (Gr.) 1 (BL) to 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 0
Title
Measurements
OG0000
OG0013
OG0022
OG003
Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Alkaline Phosphatase (U/L), High: Gr. 1 (BL) to 1
Title
Measurements
OG0001
OG0010
OG0020
OG003
Amylase (U/L), High: Gr. 0 (BL) to 0
Title
Measurements
OG0001
OG0013
OG0022
OG003
Amylase (U/L), High: Missing (BL) to Gr. 0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Amylase (U/L), High: Gr. 1 (BL) to 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Bilirubin (umol/L), High: Gr. 0 (BL) to 0
Title
Measurements
OG0001
OG0013
OG0022
OG003
Bilirubin (umol/L), High: Gr. 0 (BL) to 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood Gluc,Fast(mmol/L), High: Gr. 0(BL) to 1
Title
Measurements
OG0000
OG0010
OG0021
OG003
Blood Gluc,Fast(mmol/L), High: Gr. 1 (BL) to 1
Title
Measurements
OG0000
OG0010
OG0021
OG003
Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 2
Title
Measurements
OG0001
OG0010
OG0020
OG003
Blood Gluc.,Fast.(mmol/L), High: Missing (All)
Title
Measurements
OG0000
OG0013
OG0020
OG003
Blood Gluc,Fast(mmol/L), Low: Gr. 0 (BL) to 0
Title
Measurements
OG0000
OG0010
OG0022
OG003
Blood Gluc,Fast(mmol/L), Low: Missing(BL) to Gr 0
Title
Measurements
OG0001
OG0010
OG0020
OG003
Blood Gluc.,Fast.(mmol/L), Low: Missing (All)
Title
Measurements
OG0000
OG0013
OG0020
OG003
Calcium (mmol/L), High: Gr. 0 (BL) to 0
Title
Measurements
OG0001
OG0013
OG0022
OG003
Calcium (mmol/L), High: Gr. 1 (BL) to 0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Calcium (mmol/L), Low: Gr. 0 (BL) to 0
Title
Measurements
OG0001
OG0012
OG0022
OG003
Calcium (mmol/L), Low: Gr. 0 (BL) to 1
Title
Measurements
OG0000
OG0011
OG0020
OG003
Calcium (mmol/L), Low: Gr. 0 (BL) to 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Calcium (mmol/L), Low: Gr. 1 (BL) to 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine (umol/L), High: Gr. 0 (BL) to 0
Title
Measurements
OG0000
OG0012
OG0020
OG003
Creatinine (umol/L), High: Gr. 0 (BL) to 1
Title
Measurements
OG0000
OG0011
OG0022
OG003
Creatinine (umol/L), High: Gr. 0 (BL) to 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine (umol/L), High: Gr. 1 (BL) to 0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine (umol/L), High: Gr. 1 (BL) to 1
Title
Measurements
OG0001
OG0010
OG0020
OG003
Creatinine (umol/L), High: Gr. 1 (BL) to 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Glucose (mmol/L), High: Gr. 0 (BL) to 0
Title
Measurements
OG0000
OG0013
OG0020
OG003
Glucose (mmol/L), High: Missing (BL) to Gr. 0
Title
Measurements
OG0000
OG0010
OG0021
OG003
Glucose (mmol/L), High: Gr. 0 (BL) to 3
Title
Measurements
OG0001
OG0010
OG0020
OG003
Glucose (mmol/L), High: Missing (All)
Title
Measurements
OG0000
OG0010
OG0021
OG003
Glucose (mmol/L), Low: Gr. 0 (BL) to 0
Title
Measurements
OG0001
OG0012
OG0020
OG003
Glucose (mmol/L), Low: Missing (BL) to Gr. 0
Title
Measurements
OG0000
OG0010
OG0021
OG003
Glucose (mmol/L), Low: Gr. 0 (BL) to 1
Title
Measurements
OG0000
OG0011
OG0020
OG003
Glucose (mmol/L), Low: Missing (All)
Title
Measurements
OG0000
OG0010
OG0021
OG003
Phosphorus (mmol/L), Low: Gr. 0 (BL) to 0
Title
Measurements
OG0000
OG0012
OG0022
OG003
Phosphorus (mmol/L), Low: Missing (BL) to Gr. 0
Title
Measurements
OG0001
OG0011
OG0020
OG003
Phosphorus (mmol/L), Low: Missing (BL) to Gr. 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Phosphorus (mmol/L), Low: Missing (All)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium (mmol/L), High: Gr. 0 (BL) to 0
Title
Measurements
OG0000
OG0013
OG0022
OG003
Potassium (mmol/L), High: Gr. 0 (BL) to 1
Title
Measurements
OG0001
OG0010
OG0020
OG003
Potassium (mmol/L), Low: Gr. 0 (BL) to 0
Title
Measurements
OG0001
OG0012
OG0022
OG003
Potassium (mmol/L), Low: Gr. 0 (BL) to 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium (mmol/L), Low: Gr. 2 (BL) to 0
Title
Measurements
OG0000
OG0011
OG0020
OG003
Potassium (mmol/L), Low: Gr. 2 (BL) to 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
SGOT/AST (U/L), High: Gr. 0 (BL) to 0
Title
Measurements
OG0001
OG0012
OG0022
OG003
SGOT/AST (U/L), High: Gr. 1 (BL) to 0
Title
Measurements
OG0000
OG0011
OG0020
OG003
SGPT/ALT (U/L), High: Gr. 0 (BL) to 0
Title
Measurements
OG0001
OG0012
OG0021
OG003
SGPT/ALT (U/L), High: Gr. 1 (BL) to 0
Title
Measurements
OG0000
OG0011
OG0021
OG003
SGPT/ALT (U/L), High: Gr. 1 (BL) to 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium (mmol/L), High: Gr. 0 (BL) to 0
Title
Measurements
OG0001
OG0013
OG0022
OG003
Sodium (mmol/L), High: Gr. 0 (BL) to 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium (mmol/L), High: Gr. 1 (BL) to 0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium (mmol/L), Low: Gr. 0 (BL) to 0
Title
Measurements
OG0001
OG0013
OG0022
OG003
Sodium (mmol/L), Low: Gr. 0 (BL) to 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium (mmol/L), Low: Gr. 0 (BL) to 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium (mmol/L), Low: Gr. 1 (BL) to 0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 0
Title
Measurements
OG0000
OG0013
OG0022
OG003
Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 3
Title
Measurements
OG0001
OG0010
OG0020
OG003
Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Uric Acid (umol/L), High: Gr. 0 (BL) to 0
Title
Measurements
OG0001
OG0013
OG0022
OG003
Uric Acid (umol/L), High: Missing(BL) to Gr. 0
Title
Measurements
OG0000
OG0010
OG0020
OG003
Uric Acid (umol/L), High: Gr. 0 (BL) to 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Uric Acid (umol/L), High: Gr. 3 (BL) to 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Uric Acid (umol/L), High: Gr. 4 (BL) to 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
1 events
1 affected
4 at risk
EG0051 events1 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected2 at risk
EG0062 events1 affected4 at risk
EG0071 events1 affected5 at risk
2 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0061 events1 affected4 at risk
EG0071 events1 affected5 at risk
2 events
1 affected
3 at risk
EG0044 events4 affected4 at risk
EG0052 events1 affected2 at risk
EG00610 events3 affected4 at risk
EG0074 events3 affected5 at risk
2 events
1 affected
3 at risk
EG0042 events2 affected4 at risk
EG0052 events2 affected2 at risk
EG0067 events4 affected4 at risk
EG0076 events4 affected5 at risk
3 events
2 affected
3 at risk
EG0040 events0 affected4 at risk
EG0054 events1 affected2 at risk
EG0068 events3 affected4 at risk
EG0075 events3 affected5 at risk
2 events
2 affected
3 at risk
EG0040 events0 affected4 at risk
EG0056 events2 affected2 at risk
EG0068 events3 affected4 at risk
EG00711 events5 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0051 events1 affected2 at risk
EG0060 events0 affected4 at risk
EG0073 events2 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0063 events2 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
2 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected2 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0051 events1 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0074 events3 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0043 events1 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected2 at risk
EG0068 events3 affected4 at risk
EG0071 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected5 at risk
1 events
1 affected
3 at risk
EG0043 events2 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0062 events2 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0061 events1 affected4 at risk
EG0071 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected2 at risk
EG0061 events1 affected4 at risk
EG0071 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected2 at risk
EG0061 events1 affected4 at risk
EG0071 events1 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected5 at risk
1 events
1 affected
3 at risk
EG0041 events1 affected4 at risk
EG0051 events1 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
2 events
2 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected5 at risk
1 events
1 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0072 events2 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected2 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected5 at risk
0
OG0041
OG0050
OG0061
OG0071
0
± 0
OG0040± 0
ParticipantsOG0044
Title
Measurements
OG0001540± 21.6
OG0012210± 42.4
OG0025540± 21.5
OG0032130± 91.3
OG0042980± 49.9
ParticipantsOG0044
Title
Measurements
OG0001150± 19.9
OG0012150± 46.4
OG0024120± 27.3
OG0031660± 77.9
OG0042920± 56.8
ParticipantsOG0044
Title
Measurements
OG0001230± 20.8
OG0013570± 68.4
OG0027850± 23
OG0032970± 53.2
OG0044970± 45.7
ParticipantsOG0043
Title
Measurements
OG0001670± 17.5
OG0014360± 67.6
OG0027930± 15.5
OG0032910± 73.2
OG0045910± 54.6
ParticipantsOG0043
Title
Measurements
OG0001730± 15.5
OG0014220± 94.8
OG0027310± 13.6
OG0032820± 68.7
OG0045200± 49.8
ParticipantsOG0044
Title
Measurements
OG0001150± 19.9
OG0012150± 46.4
OG0024120± 27.3
OG0031660± 77.9
OG0042920± 56.8
ParticipantsOG0040
Title
Measurements
OG0000± 0
OG0010± 0
OG0030± 0
ParticipantsOG0040
Title
Measurements
OG0001660± 33.1
OG0012480± 51.5
OG0031260± 49.8
ParticipantsOG0040
Title
Measurements
OG0012380± 27.2
OG0032400± 67
ParticipantsOG0040
Title
Measurements
OG0014050± 54.9
ParticipantsOG0040
Title
Measurements
OG0014200± 38.2
ParticipantsOG0040
Title
Measurements
OG0014010± 31.6
ParticipantsOG0040
Title
Measurements
OG0012380± 27.2
ParticipantsOG0040
Title
Measurements
OG0010± 0
ParticipantsOG0040
Title
Measurements
OG0012730± 9.9
ParticipantsOG0040
Title
Measurements
OG0012600± 25.6
ParticipantsOG0040
Title
Measurements
OG0015210± 19.5
ParticipantsOG0040
Title
Measurements
OG0012600± 25.6
0
OG0040
OG0050
OG0060
OG0070
2
OG0043
OG0051
OG0063
OG0074
0
OG0042
OG0051
OG0061
OG0072
1
OG0041
OG0050
OG0062
OG0072
0
OG0040
OG0050
OG0060
OG0070
0
OG0041
OG0050
OG0063
OG0071
0
OG0040
OG0050
OG0060
OG0070
2
OG0044
OG0051
OG0064
OG0075
1
OG0042
OG0051
OG0063
OG0074
0
OG0041
OG0050
OG0060
OG0072
0
OG0041
OG0050
OG0063
OG0075
0
OG0040
OG0050
OG0062
OG0073
0
OG0040
OG0050
OG0061
OG0071
2
OG0042
OG0050
OG0060
OG0070
1
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
1
OG0041
OG0050
OG0062
OG0071
125.7
± 39.4
OG004119.0± 16.8
OG005120.5± 17.7
OG006109.3± 9.1
OG007116.4± 10.5
ParticipantsOG0044
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0075
Title
Measurements
OG000-34.0± NAStandard deviation could not be calculated from data for a single participant.
OG001-2.0± 10.5
OG002-5.0± 4.2
OG003-2.7± 14.6
OG004-0.8± 10.6
OG005-3.5± 10.6
OG0063.5± 9.4
OG0074.8± 14.8
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0075
Title
Measurements
OG000-4.0± NAStandard deviation could not be calculated from data for a single participant.
OG001-5.0± 8.5
OG002-7.0± 8.5
OG005-6.5± 6.4
OG006-2.3± 15.2
OG0076.4± 10.3
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0075
Title
Measurements
OG00024.0± NAStandard deviation could not be calculated from data for a single participant.
OG001-5.3± 14.6
OG005-3.5± 7.8
OG0069.7± 13.4
OG0078.0± 12.9
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG0075
Title
Measurements
OG000-17.0± NAStandard deviation could not be calculated from data for a single participant.
OG001-3.5± 19.1
OG0030.0± 39.6
OG005-14.0± NAStandard deviation could not be calculated from data for a single participant.
OG0064.5± 4.9
OG0078.6± 10.4
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0073
Title
Measurements
OG000-1.0± NAStandard deviation could not be calculated from data for a single participant.
OG00111.0± NAStandard deviation could not be calculated from data for a single participant.
OG005-13.5± 3.5
OG00610.5± 2.1
OG0077.0± 8.9
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0071
Title
Measurements
OG000-22.0± NAStandard deviation could not be calculated from data for a single participant.
OG00512.5± 27.6
OG0062.0± 1.4
OG007-10.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0072
Title
Measurements
OG000-21.0± NAStandard deviation could not be calculated from data for a single participant.
OG0050.5± 4.9
OG00612.5± 9.2
OG0078.5± 9.2
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0072
Title
Measurements
OG005-2.0± NAStandard deviation could not be calculated from data for a single participant.
OG00620.0± NAStandard deviation could not be calculated from data for a single participant.
OG0070.5± 0.7
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0072
Title
Measurements
OG005-14.0± NAStandard deviation could not be calculated from data for a single participant.
OG00714.0± 9.9
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0072
Title
Measurements
OG0059.0± NAStandard deviation could not be calculated from data for a single participant.
OG0077.5± 10.6
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG005-12.0± NAStandard deviation could not be calculated from data for a single participant.
OG0079.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG005-5.0± NAStandard deviation could not be calculated from data for a single participant.
OG0070.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG005-3.0± NAStandard deviation could not be calculated from data for a single participant.
OG0077.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG005-5.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG005-5.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG005-9.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG005-35.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0052.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG005-21.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0074
Title
Measurements
OG000-32.0± NAStandard deviation could not be calculated from data for a single participant.
OG002-3.5± 9.2
OG003-25.0± 55.2
OG004-3.5± 0.7
OG0059.5± 3.5
OG00620.0± 15.5
OG007-1.3± 9.0
72.3
± 12.3
OG00470.3± 7.6
OG00571.5± 9.2
OG00676.3± 12.7
OG00765.8± 6.9
ParticipantsOG0044
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0075
Title
Measurements
OG000-17.0± NAStandard deviation could not be calculated from data for a single participant.
OG001-2.0± 19.5
OG002-2.5± 2.1
OG0037.3± 23.1
OG004-2.3± 7.4
OG005-2.0± 4.2
OG0063.0± 4.9
OG0076.4± 2.1
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0075
Title
Measurements
OG000-1.0± NAStandard deviation could not be calculated from data for a single participant.
OG0011.3± 15.0
OG002-2.5± 6.4
OG005-2.0± 0.0
OG006-6.5± 1.3
OG0079.2± 8.5
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0075
Title
Measurements
OG000-1.0± NAStandard deviation could not be calculated from data for a single participant.
OG0013.0± 16.4
OG0056.0± 4.2
OG0060.0± 6.6
OG0072.4± 8.3
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG0075
Title
Measurements
OG0007.0± NAStandard deviation could not be calculated from data for a single participant.
OG0010.0± 17.0
OG0033.5± 13.4
OG0050.0± NAStandard deviation could not be calculated from data for a single participant.
OG006-8.0± 2.8
OG00712.0± 5.1
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0073
Title
Measurements
OG0003.0± NAStandard deviation could not be calculated from data for a single participant.
OG0013.0± NAStandard deviation could not be calculated from data for a single participant.
OG005-5.5± 6.4
OG006-1.0± 4.2
OG0075.3± 5.0
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0071
Title
Measurements
OG000-4.0± NAStandard deviation could not be calculated from data for a single participant.
OG0053.0± 8.5
OG006-8.0± 7.1
OG0077.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0072
Title
Measurements
OG000-2.0± NAStandard deviation could not be calculated from data for a single participant.
OG0053.5± 0.7
OG006-2.0± 7.1
OG0072.5± 4.9
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0072
Title
Measurements
OG00510.0± NAStandard deviation could not be calculated from data for a single participant.
OG0069.0± NAStandard deviation could not be calculated from data for a single participant.
OG0072.5± 3.5
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0072
Title
Measurements
OG0050.0± NAStandard deviation could not be calculated from data for a single participant.
OG0072.0± 0.0
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0072
Title
Measurements
OG00514.0± NAStandard deviation could not be calculated from data for a single participant.
OG0075.0± 8.5
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG005-7.0± NAStandard deviation could not be calculated from data for a single participant.
OG007-5.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG0057.0± NAStandard deviation could not be calculated from data for a single participant.
OG007-1.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG0056.0± NAStandard deviation could not be calculated from data for a single participant.
OG0073.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG005-13.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0051.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0059.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG005-4.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0057.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0050.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0074
Title
Measurements
OG000-16.0± NAStandard deviation could not be calculated from data for a single participant.
OG002-9.0± 21.2
OG003-15.5± 20.5
OG0044.0± 4.2
OG00510.5± 2.1
OG0067.5± 20.2
OG0079.3± 3.3
81.7
± 3.1
OG00476.0± 10.6
OG00577.5± 12.0
OG00679.5± 18.6
OG00780.2± 9.9
ParticipantsOG0044
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0075
Title
Measurements
OG00010.0± NAStandard deviation could not be calculated from data for a single participant.
OG00115.7± 21.5
OG002-9.0± 8.5
OG0030.0± 9.8
OG0048.8± 12.0
OG0052.5± 14.8
OG0062.3± 6.4
OG0079.0± 11.1
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0075
Title
Measurements
OG000-2.0± NAStandard deviation could not be calculated from data for a single participant.
OG00111.0± 2.0
OG002-2.0± 1.4
OG005-0.5± 20.5
OG0062.3± 6.4
OG0079.0± 11.1
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0075
Title
Measurements
OG000-11.0± NAStandard deviation could not be calculated from data for a single participant.
OG00112.7± 13.4
OG005-3.5± 16.3
OG006-1.7± 13.1
OG0073.2± 14.5
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG0075
Title
Measurements
OG0004.0± NAStandard deviation could not be calculated from data for a single participant.
OG00117.5± 17.7
OG0037.0± 1.4
OG005-17.0± NAStandard deviation could not be calculated from data for a single participant.
OG006-2.5± 4.9
OG0076.4± 9.7
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0073
Title
Measurements
OG000-1.0± NAStandard deviation could not be calculated from data for a single participant.
OG00119.0± NAStandard deviation could not be calculated from data for a single participant.
OG005-1.5± 16.3
OG006-4.5± 20.5
OG007-3.5± 10.6
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0071
Title
Measurements
OG0001.0± NAStandard deviation could not be calculated from data for a single participant.
OG005-7.0± 12.7
OG006-5.0± 5.7
OG0074.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0072
Title
Measurements
OG00015.0± NAStandard deviation could not be calculated from data for a single participant.
OG005-6.5± 10.6
OG0063.0± 28.3
OG0076.5± 4.9
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0072
Title
Measurements
OG005-1.0± NAStandard deviation could not be calculated from data for a single participant.
OG00631.0± NAStandard deviation could not be calculated from data for a single participant.
OG00715.0± 2.8
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0072
Title
Measurements
OG0056.0± NAStandard deviation could not be calculated from data for a single participant.
OG00710.0± 5.7
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0072
Title
Measurements
OG0050.0± NAStandard deviation could not be calculated from data for a single participant.
OG0072.0± 9.9
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG005-5.0± NAStandard deviation could not be calculated from data for a single participant.
OG00711.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG0051.0± NAStandard deviation could not be calculated from data for a single participant.
OG0072.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG0056.0± NAStandard deviation could not be calculated from data for a single participant.
OG00711.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG00518.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG00511.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0052.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG005-2.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0051.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG00513.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0074
Title
Measurements
OG00015.0± NAStandard deviation could not be calculated from data for a single participant.
OG002-20.0± 18.4
OG00311.5± 10.6
OG00423.5± 20.5
OG00515.0± 8.5
OG0065.8± 14.8
OG00710.3± 9.2
17.0
± 1.7
OG00417.0± 2.0
OG00516.0± 0.0
OG00616.0± 3.3
OG00716.8± 3.0
ParticipantsOG0044
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0073
Title
Measurements
OG0000.0± NAStandard deviation could not be calculated from data for a single participant.
OG0010.7± 1.2
OG002-1.0± 1.4
OG003-0.7± 1.2
OG0040.3± 1.3
OG0051.0± 1.4
OG0062.3± 0.5
OG0070.0± 0.0
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0075
Title
Measurements
OG0000.0± NAStandard deviation could not be calculated from data for a single participant.
OG001-1.7± 2.1
OG002-1.0± 1.4
OG0050.0± 0.0
OG0062.0± 4.0
OG0070.0± 2.4
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0075
Title
Measurements
OG0000.0± NAStandard deviation could not be calculated from data for a single participant.
OG001-3.5± 2.1
OG0051.0± 1.4
OG0061.7± 1.5
OG007-0.2± 2.7
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG0074
Title
Measurements
OG0000.0± NAStandard deviation could not be calculated from data for a single participant.
OG001-2.5± 3.5
OG0030.5± 0.7
OG0050.0± NAStandard deviation could not be calculated from data for a single participant.
OG0064.0± 5.7
OG0070.0± 4.6
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0073
Title
Measurements
OG0002.0± NAStandard deviation could not be calculated from data for a single participant.
OG001-4.0± NAStandard deviation could not be calculated from data for a single participant.
OG0050.0± 0.0
OG0064.0± 5.7
OG007-1.0± 4.2
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0071
Title
Measurements
OG000-2.0± NAStandard deviation could not be calculated from data for a single participant.
OG0050.0± 0.0
OG0062.0± 2.8
OG0074.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0072
Title
Measurements
OG0000.0± NAStandard deviation could not be calculated from data for a single participant.
OG0050.0± 0.0
OG0061.0± 1.4
OG0070.0± 5.7
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0072
Title
Measurements
OG005-4.0± NAStandard deviation could not be calculated from data for a single participant.
OG0065.0± NAStandard deviation could not be calculated from data for a single participant.
OG007-2.0± 2.8
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0072
Title
Measurements
OG005-4.0± NAStandard deviation could not be calculated from data for a single participant.
OG007-1.0± 4.2
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0072
Title
Measurements
OG0050.0± NAStandard deviation could not be calculated from data for a single participant.
OG007-2.0± 2.8
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG0050.0± NAStandard deviation could not be calculated from data for a single participant.
OG007-4.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG0050.0± NAStandard deviation could not be calculated from data for a single participant.
OG007-4.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG0052.0± NAStandard deviation could not be calculated from data for a single participant.
OG007-4.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0050.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0050.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0050.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0052.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0050.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0052.0± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0073
Title
Measurements
OG000-2.0± NAStandard deviation could not be calculated from data for a single participant.
OG002-2.0± 2.8
OG003-4.0± NAStandard deviation could not be calculated from data for a single participant.
OG0040.0± 2.8
OG0051.0± 1.4
OG0063.3± 3.2
OG007-0.7± 3.1
36.83
± 0.15
OG00436.58± 0.34
OG00536.55± 0.21
OG00636.50± 0.18
OG00736.70± 3.3
ParticipantsOG0044
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0073
Title
Measurements
OG0000.00± NAStandard deviation could not be calculated from data for a single participant.
OG0010.00± 0.92
OG002-0.15± 0.21
OG003-0.07± 0.15
OG0040.18± 0.33
OG0050.05± 0.49
OG0060.30± 0.22
OG007-0.18± 0.30
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0075
Title
Measurements
OG0000.10± NAStandard deviation could not be calculated from data for a single participant.
OG0010.37± 0.50
OG0020.95± 0.85
OG0050.30± 0.28
OG006-0.13± 0.22
OG0070.10± 0.45
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0075
Title
Measurements
OG0000.10± NAStandard deviation could not be calculated from data for a single participant.
OG0010.20± 0.82
OG0050.20± 0.28
OG006-0.23± 0.45
OG007-0.18± 0.26
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG0075
Title
Measurements
OG0000.00± NAStandard deviation could not be calculated from data for a single participant.
OG0010.10± 0.14
OG003-0.30± 0.14
OG005-0.50± NAStandard deviation could not be calculated from data for a single participant.
OG006-0.25± 0.49
OG007-0.04± 0.09
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0073
Title
Measurements
OG000-0.20± NAStandard deviation could not be calculated from data for a single participant.
OG001-0.10± NAStandard deviation could not be calculated from data for a single participant.
OG005-0.10± 0.42
OG006-0.50± 0.28
OG007-0.17± 0.21
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0071
Title
Measurements
OG0000.00± NAStandard deviation could not be calculated from data for a single participant.
OG0050.05± 0.64
OG0060.05± 0.21
OG007-0.10± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0072
Title
Measurements
OG0000.20± NAStandard deviation could not be calculated from data for a single participant.
OG0050.35± 0.64
OG006-0.35± 0.49
OG007-0.20± 0.14
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0072
Title
Measurements
OG0050.20± NAStandard deviation could not be calculated from data for a single participant.
OG0060.20± NAStandard deviation could not be calculated from data for a single participant.
OG007-0.05± 0.21
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0072
Title
Measurements
OG0050.60± NAStandard deviation could not be calculated from data for a single participant.
OG007-0.20± 0.14
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0072
Title
Measurements
OG0050.40± NAStandard deviation could not be calculated from data for a single participant.
OG007-0.20± 0.57
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG0050.20± NAStandard deviation could not be calculated from data for a single participant.
OG007-0.20± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG0050.60± NAStandard deviation could not be calculated from data for a single participant.
OG007-0.10± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG0050.30± NAStandard deviation could not be calculated from data for a single participant.
OG0070.20± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0050.70± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0050.40± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0050.70± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0050.40± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0050.80± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0050.50± NAStandard deviation could not be calculated from data for a single participant.
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0073
Title
Measurements
OG0000.10± NAStandard deviation could not be calculated from data for a single participant.