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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2015-002100-83
    Trial protocol
    		 DE  
    Global end of trial date
    20 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 May 2020
    First version publication date
    15 May 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BH29812
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02624986
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche, Ltd.
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche, Ltd., F. Hoffmann-La Roche, Ltd., +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche, Ltd., F. Hoffmann-La Roche, Ltd., +41 616878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 May 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    20 May 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary safety objective was to determine the recommended Phase II dose (RP2D) for idasanutlin when given in combination with a fixed dose of obinutuzumab or rituximab on the basis of the incidence of dose-limiting toxicities. The primary efficacy objective for this study is to evaluate the efficacy of obinutuzumab in combination with idasanutlin in relapsed/refractory (R/R) follicular lymphoma (FL) and rituximab in combination with idasanutlin in R/R diffuse large B-cell lymphoma (DLBCL).
    Protection of trial subjects
    This study was conducted in full conformance with the ICH E6 guideline for GCP and the principles of the Declaration of Helsinki, or the laws and regulations of the country in which the research is conducted, whichever afforded the greater protection to the individual. All study subjects were required to read and sign an informed consent form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Dec 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 6
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    New Zealand: 3
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    25
    EEA total number of subjects
    5
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    18
    From 65 to 84 years
    6
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening 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.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg
    Arm description
    		 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).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Idasanutlin
    Investigational medicinal product code
    RO5503781/F17-01
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Idasanutlin 100 milligrams (mg) was taken orally once per day on Days 1 to 5 of each 28-day cycle for up to 6 cycles of induction treatment. Participants with DLBCL who achieved a complete response according to modified Lugano 2014 criteria at the end of induction were allowed to proceed to hematopoietic stem cell transplantation if deemed appropriate by the investigator.

    Investigational medicinal product name
    Obinutuzumab
    Investigational medicinal product code
    RO5072759/F06-01
    Other name
    Gazyvaro
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A flat dose of obinutuzumab 1000 mg was administered intravenously (IV) on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (1 cycle was 28 days) of induction treatment. Participants with DLBCL who achieved a complete response according to modified Lugano 2014 criteria at the end of induction were allowed to proceed to hematopoietic stem cell transplantation if deemed appropriate by the investigator.

    Arm title
    		 DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Arm description
    		 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).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Obinutuzumab
    Investigational medicinal product code
    RO5072759/F06-01
    Other name
    Gazyvaro
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A flat dose of obinutuzumab 1000 mg was administered IV on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (1 cycle was 28 days) of induction treatment. Participants with DLBCL who achieved a complete response according to modified Lugano 2014 criteria at the end of induction were allowed to proceed to hematopoietic stem cell transplantation if deemed appropriate by the investigator.

    Investigational medicinal product name
    Idasanutlin
    Investigational medicinal product code
    RO5503781/F17-01
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Idasanutlin 150 mg was taken orally once per day on Days 1 to 5 of each 28-day cycle for up to 6 cycles of induction treatment. Participants with DLBCL who achieved a complete response according to modified Lugano 2014 criteria at the end of induction were allowed to proceed to hematopoietic stem cell transplantation if deemed appropriate by the investigator.

    Arm title
    		 DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg
    Arm description
    		 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).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Idasanutlin
    Investigational medicinal product code
    RO5503781/F16-01
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Idasanutlin 200 mg was taken orally once per day on Days 1 to 5 of each 28-day cycle for up to 6 cycles of induction treatment. Participants with DLBCL who achieved a complete response according to modified Lugano 2014 criteria at the end of induction were allowed to proceed to hematopoietic stem cell transplantation if deemed appropriate by the investigator.

    Investigational medicinal product name
    Obinutuzumab
    Investigational medicinal product code
    RO5072759/F06-01
    Other name
    Gazyvaro
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A flat dose of obinutuzumab 1000 mg was administered IV on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (1 cycle was 28 days) of induction treatment. Participants with DLBCL who achieved a complete response according to modified Lugano 2014 criteria at the end of induction were allowed to proceed to hematopoietic stem cell transplantation if deemed appropriate by the investigator.

    Arm title
    		 DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2
    Arm description
    		 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).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Idasanutlin
    Investigational medicinal product code
    RO5503781/F17-01
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Idasanutlin 150 mg was taken orally once per day on Days 1 to 5 of each 28-day cycle for up to 6 cycles of induction treatment. Participants with DLBCL who achieved a complete response according to modified Lugano 2014 criteria at the end of induction were allowed to proceed to hematopoietic stem cell transplantation if deemed appropriate by the investigator.

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Mabthera
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Rituximab 375 mg per square metre of body surface area (mg/m^2) was administered IV on Day 1 of each 28-day cycle for up to 6 cycles of induction treatment. Participants with DLBCL who achieved a complete response according to modified Lugano 2014 criteria at the end of induction were allowed to proceed to hematopoietic stem cell transplantation if deemed appropriate by the investigator.

    Arm title
    		 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2
    Arm description
    		 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).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Idasanutlin
    Investigational medicinal product code
    RO5503781/F16-01
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Idasanutlin 200 mg was taken orally once per day on Days 1 to 5 of each 28-day cycle for up to 6 cycles of induction treatment. Participants with DLBCL who achieved a complete response according to modified Lugano 2014 criteria at the end of induction were allowed to proceed to hematopoietic stem cell transplantation if deemed appropriate by the investigator.

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Mabthera
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Rituximab 375 mg/m^2 was administered IV on Day 1 of each 28-day cycle for up to 6 cycles of induction treatment. Participants with DLBCL who achieved a complete response according to modified Lugano 2014 criteria at the end of induction were allowed to proceed to hematopoietic stem cell transplantation if deemed appropriate by the investigator.

    Arm title
    		 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg
    Arm description
    		 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).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Idasanutlin
    Investigational medicinal product code
    RO5503781/F17-01
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Idasanutlin 100 milligrams (mg) was taken orally once per day on Days 1 to 5 of each 28-day cycle for up to 6 cycles of induction treatment. Participants with FL who achieved a complete response or partial response according to modified Lugano 2014 criteria at the end of induction were to receive maintenance treatment with obinutuzumab.

    Investigational medicinal product name
    Obinutuzumab
    Investigational medicinal product code
    RO5072759/F06-01
    Other name
    Gazyvaro
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A flat dose of obinutuzumab 1000 mg was administered IV on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (1 cycle was 28 days) of induction treatment. Participants with FL who achieved a complete response or partial response according to modified Lugano 2014 criteria at the end of induction were to receive maintenance treatment with obinutuzumab 1000 mg IV once every 2 months until disease progression or unacceptable toxicity for up to 2 years.

    Arm title
    		 FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Arm description
    		 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).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Idasanutlin
    Investigational medicinal product code
    RO5503781/F17-01
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Idasanutlin 150 mg was taken orally once per day on Days 1 to 5 of each 28-day cycle for up to 6 cycles of induction treatment. Participants with FL who achieved a complete response or partial response according to modified Lugano 2014 criteria at the end of induction were to receive maintenance treatment with obinutuzumab.

    Investigational medicinal product name
    Obinutuzumab
    Investigational medicinal product code
    RO5072759/F06-01
    Other name
    Gazyvaro
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A flat dose of obinutuzumab 1000 mg was administered IV on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (1 cycle was 28 days) of induction treatment. Participants with FL who achieved a complete response or partial response according to modified Lugano 2014 criteria at the end of induction were to receive maintenance treatment with obinutuzumab 1000 mg IV once every 2 months until disease progression or unacceptable toxicity for up to 2 years.

    Arm title
    		 FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Arm description
    		 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).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Idasanutlin
    Investigational medicinal product code
    RO5503781/F17-01
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Idasanutlin 150 mg was taken orally once per day on Days 1 to 5 of each 28-day cycle starting at Cycle 2 for up to 5 cycles of induction treatment. Participants with FL who achieved a complete response or partial response according to modified Lugano 2014 criteria at the end of induction were to receive maintenance treatment with obinutuzumab.

    Investigational medicinal product name
    Obinutuzumab
    Investigational medicinal product code
    RO5072759/F06-01
    Other name
    Gazyvaro
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A flat dose of obinutuzumab 1000 mg was administered IV on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (1 cycle was 28 days) of induction treatment. Participants with FL who achieved a complete response or partial response according to modified Lugano 2014 criteria at the end of induction were to receive maintenance treatment with obinutuzumab 1000 mg IV once every 2 months until disease progression or unacceptable toxicity for up to 2 years.

    Number of subjects in period 1
    		DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Started
    2
    3
    2
    3
    4
    2
    4
    5
    Received Any Study Treatment
    1
    3
    2
    3
    4
    2
    4
    5
    Completed
    0
    0
    0
    0
    0
    0
    0
    0
    Not completed
    2
    3
    2
    3
    4
    2
    4
    5
         Consent withdrawn by subject
    -
    -
    -
    -
    -
    -
    -
    1
         Death
    -
    1
    2
    2
    2
    -
    -
    1
         Progressive Disease
    -
    1
    -
    -
    -
    -
    -
    -
         Study Terminated by Sponsor
    1
    1
    -
    1
    2
    2
    4
    3
         Protocol deviation
    1
    -
    -
    -
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg
    Reporting group description
    		 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).

    Reporting group title
    DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Reporting group description
    		 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).

    Reporting group title
    DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg
    Reporting group description
    		 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).

    Reporting group title
    DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2
    Reporting group description
    		 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).

    Reporting group title
    DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2
    Reporting group description
    		 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).

    Reporting group title
    FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg
    Reporting group description
    		 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).

    Reporting group title
    FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Reporting group description
    		 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).

    Reporting group title
    FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Reporting group description
    		 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).

    Reporting group values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg Total
    Number of subjects
    		 2 3 2 3 4 2 4 5 25
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 1 1 2 2 3 2 4 3 18
        From 65-84 years
    		 1 1 0 1 1 0 0 2 6
        85 years and over
    		 0 1 0 0 0 0 0 0 1
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 62.5 ( 6.4 ) 70.7 ( 15.2 ) 55.5 ( 10.6 ) 67.3 ( 8.4 ) 56.5 ( 12.9 ) 52.5 ( 6.4 ) 53.3 ( 6.7 ) 64.2 ( 9.8 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 1 1 1 1 2 0 2 4 12
        Male
    		 1 2 1 2 2 2 2 1 13
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0 0 0 0
        Asian
    		 0 0 2 0 1 1 2 0 6
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0 0 0 0 0
        White
    		 2 3 0 2 3 1 1 5 17
        More than one race
    		 0 0 0 0 0 0 1 0 1
        Unknown or Not Reported
    		 0 0 0 1 0 0 0 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 1 0 0 0 0 1
        Not Hispanic or Latino
    		 2 3 2 2 3 2 4 5 23
        Unknown or Not Reported
    		 0 0 0 0 1 0 0 0 1

    End points

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    End points reporting groups
    Reporting group title
    DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg
    Reporting group description
    		 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).

    Reporting group title
    DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Reporting group description
    		 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).

    Reporting group title
    DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg
    Reporting group description
    		 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).

    Reporting group title
    DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2
    Reporting group description
    		 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).

    Reporting group title
    DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2
    Reporting group description
    		 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).

    Reporting group title
    FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg
    Reporting group description
    		 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).

    Reporting group title
    FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Reporting group description
    		 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).

    Reporting group title
    FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Reporting group description
    		 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).

    Subject analysis set title
    DLBCL/FL Combined: Idasanutlin 100 mg + Obinutuzumab 1000 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is a pharmacokinetics analysis cohort of participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) who 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).

    Subject analysis set title
    DLBCL/FL Combined: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is a pharmacokinetics analysis cohort of participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) who 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).

    Subject analysis set title
    DLBCL/FL: Idasanutlin 100/150/200 mg + Obinutuzumab 1000 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is a pharmacokinetics analysis cohort of participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) who 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).

    Subject analysis set title
    DLBCL Combined: Idasanutlin 150/200 mg + Rituximab 375 mg/m^2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This is a pharmacokinetics analysis cohort of participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) who 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).

    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

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    End point title
    		 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 [1]
    End point description
    The plan was for the IRC to evaluate 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 to be considered non-responders.
    End point type
    Primary
    End point timeframe
    Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary end point was to be analyzed based on responses of subjects in the dose expansion phase as evaluated by the IRC; however, there are no results to report because the dose expansion phase did not open for enrollment. The sponsor decided to terminate the study early due to the modest benefit achieved at the maximum tolerated dose during the dose escalation phase.
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    0 [7]
    0 [8]
    0 [9]
    Units: Percentage of participants
        number (confidence interval 90%)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [2] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [3] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [4] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [5] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [6] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [7] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [8] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [9] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    No statistical analyses for this end point

    Secondary: Number of Participants with a Dose-Limiting Toxicity

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    End point title
    		 Number of Participants with a Dose-Limiting Toxicity
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Cycles 1, 2 (1 cycle is 28 days)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    1
    3
    2
    3
    4
    2
    4
    5
    Units: Participants
        Any DLT
    0
    0
    2
    0
    1
    0
    1
    1
        Thrombocytopenia
    0
    0
    2
    0
    1
    0
    1
    1
    No statistical analyses for this end point

    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

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    End point title
    		 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
    End point description
    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. Exploratory analysis of dose-escalation phase efficacy is reported.
    End point type
    Secondary
    End point timeframe
    Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    2
    3
    2
    3
    4
    2
    4
    5
    Units: Percentage of participants
        number (confidence interval 90%)
    0 (0.00 to 77.64)
    33.3 (1.70 to 86.46)
    0 (0.00 to 77.64)
    0 (0.00 to 63.16)
    0 (0.00 to 52.71)
    50.0 (2.53 to 97.47)
    0 (0.00 to 52.71)
    40.0 (7.64 to 81.07)
    No statistical analyses for this end point

    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

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    End point title
    		 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
    End point description
    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 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. Exploratory analysis of dose-escalation phase efficacy is reported.
    End point type
    Secondary
    End point timeframe
    Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    2
    3
    2
    3
    4
    2
    4
    5
    Units: Percentage of participants
        number (confidence interval 90%)
    0 (0.00 to 77.64)
    33.3 (1.70 to 86.46)
    0 (0.00 to 77.64)
    0 (0.00 to 63.16)
    0 (0.00 to 52.71)
    50.0 (2.53 to 97.47)
    0 (0.00 to 52.71)
    40.0 (7.64 to 81.07)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Complete Response at the End of Induction, Determined by the IRC on the Basis of CT Scans Alone Using Lugano 2014 Criteria

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    End point title
    		 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
    End point description
    The independent review committee (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.
    End point type
    Secondary
    End point timeframe
    Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    0 [10]
    0 [11]
    0 [12]
    0 [13]
    0 [14]
    0 [15]
    0 [16]
    0 [17]
    Units: Percentage of participants
        number (confidence interval 90%)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [10] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [11] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [12] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [13] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [14] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [15] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [16] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [17] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    No statistical analyses for this end point

    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

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    End point title
    		 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
    End point description
    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. Exploratory analysis of dose-escalation phase efficacy is reported.
    End point type
    Secondary
    End point timeframe
    Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    2
    3
    2
    3
    4
    2
    4
    5
    Units: Percentage of participants
        number (confidence interval 90%)
    0 (0.00 to 77.64)
    33.3 (1.70 to 86.46)
    0 (0.00 to 77.64)
    0 (0.00 to 63.16)
    0 (0.00 to 52.71)
    0 (0.00 to 77.64)
    0 (0.00 to 52.71)
    20.0 (1.02 to 65.74)
    No statistical analyses for this end point

    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

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    End point title
    		 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
    End point description
    The plan was for the IRC 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. Subjects without a post-baseline tumor assessment were to be considered non-responders.
    End point type
    Secondary
    End point timeframe
    Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    0 [18]
    0 [19]
    0 [20]
    0 [21]
    0 [22]
    0 [23]
    0 [24]
    0 [25]
    Units: Percentage of participants
        number (confidence interval 90%)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [18] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [19] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [20] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [21] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [22] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [23] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [24] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    [25] - Sponsor terminated the study due to modest benefit achieved; responses were not analyzed by the IRC.
    No statistical analyses for this end point

    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

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    End point title
    		 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
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    0 [26]
    0 [27]
    0 [28]
    0 [29]
    0 [30]
    0 [31]
    0 [32]
    0 [33]
    Units: Percentage of participants
        number (confidence interval 90%)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [26] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [27] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [28] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [29] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [30] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [31] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [32] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [33] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    No statistical analyses for this end point

    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

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    End point title
    		 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
    End point description
    The plan was for the IRC 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.
    End point type
    Secondary
    End point timeframe
    Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    0 [34]
    0 [35]
    0 [36]
    0 [37]
    0 [38]
    0 [39]
    0 [40]
    0 [41]
    Units: Percentage of participants
        number (confidence interval 90%)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [34] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [35] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [36] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [37] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [38] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [39] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [40] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [41] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    No statistical analyses for this end point

    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

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    End point title
    		 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
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    0 [42]
    0 [43]
    0 [44]
    0 [45]
    0 [46]
    0 [47]
    0 [48]
    0 [49]
    Units: Percentage of participants
        number (confidence interval 90%)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [42] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [43] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [44] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [45] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [46] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [47] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [48] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    [49] - Sponsor terminated the study due to modest benefit achieved; objective responses were not analyzed.
    No statistical analyses for this end point

    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

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    End point title
    		 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
    End point description
    The investigator was to evaluate responses during 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.
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    0 [50]
    0 [51]
    0 [52]
    0 [53]
    0 [54]
    0 [55]
    0 [56]
    0 [57]
    Units: Percentage of participants
        number (confidence interval 90%)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [50] - Sponsor terminated the study due to modest benefit achieved; best responses were not analyzed.
    [51] - Sponsor terminated the study due to modest benefit achieved; best responses were not analyzed.
    [52] - Sponsor terminated the study due to modest benefit achieved; best responses were not analyzed.
    [53] - Sponsor terminated the study due to modest benefit achieved; best responses were not analyzed.
    [54] - Sponsor terminated the study due to modest benefit achieved; best responses were not analyzed.
    [55] - Sponsor terminated the study due to modest benefit achieved; best responses were not analyzed.
    [56] - Sponsor terminated the study due to modest benefit achieved; best responses were not analyzed.
    [57] - Sponsor terminated the study due to modest benefit achieved; best responses were not analyzed.
    No statistical analyses for this end point

    Secondary: Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab)

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    End point title
    		 Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) [58]
    End point description
    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. The value '999999' in the results table indicates that the geometric mean and coefficient of variation were not available because 0 participants were analyzed at a given timepoint.
    End point type
    Secondary
    End point timeframe
    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)
    Notes
    [58] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data from subjects in the DLBCL and FL arms who received idasanutlin and obinutuzumab at the same doses (i.e., 100 mg + 1000 mg and 150 mg + 1000 mg, respectively) were pooled together for this PK analysis and reported under combined subject analysis sets.
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 DLBCL/FL Combined: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL/FL Combined: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    2
    3
    4
    3
    12
    Units: nanograms per millilitre (ng/mL)
    geometric mean (geometric coefficient of variation)
        Cycle 1, Day 1: 0 hours (n=2,3,4,3,6)
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
        Cycle 1, Day 1: 6 hours (n=2,3,4,3,6)
    5540 ( 21.5 )
    2130 ( 91.3 )
    2980 ( 49.9 )
    1540 ( 21.6 )
    2210 ( 42.4 )
        Cycle 1, Day 5: 0 hours (n=2,3,4,3,5)
    4120 ( 27.3 )
    1660 ( 77.9 )
    2920 ( 56.8 )
    1150 ( 19.9 )
    2150 ( 46.4 )
        Cycle 1, Day 5: 2 hours (n=2,3,4,3,5)
    7850 ( 23 )
    2970 ( 53.2 )
    4970 ( 45.7 )
    1230 ( 20.8 )
    3570 ( 68.4 )
        Cycle 1, Day 5: 4 hours (n=2,3,3,3,5)
    7930 ( 15.5 )
    2910 ( 73.2 )
    5910 ( 54.6 )
    1670 ( 17.5 )
    4360 ( 67.6 )
        Cycle 1, Day 5: 6 hours (n=2,3,3,3,5)
    7310 ( 13.6 )
    2820 ( 68.7 )
    5200 ( 49.8 )
    1730 ( 15.5 )
    4220 ( 94.8 )
        Cycle 1, Day 5: 24 hours (n=2,3,4,3,5)
    4120 ( 27.3 )
    1660 ( 77.9 )
    2920 ( 56.8 )
    1150 ( 19.9 )
    2150 ( 46.4 )
        Cycle 2, Day 1: 0 hours (n=0,3,0,3,10)
    999999 ( 999999 )
    0 ( 0 )
    999999 ( 999999 )
    0 ( 0 )
    0 ( 0 )
        Cycle 2, Day 1: 6 hours (n=0,3,0,3,10)
    999999 ( 999999 )
    1260 ( 49.8 )
    999999 ( 999999 )
    1660 ( 33.1 )
    2480 ( 51.5 )
        Cycle 2, Day 5: 0 hours (n=0,2,0,0,7)
    999999 ( 999999 )
    2400 ( 67 )
    999999 ( 999999 )
    999999 ( 999999 )
    2380 ( 27.2 )
        Cycle 2, Day 5: 2 hours (n=0,0,0,0,5)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    4050 ( 54.9 )
        Cycle 2, Day 5: 4 hours (n=0,0,0,0,5)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    4200 ( 38.2 )
        Cycle 2, Day 5: 6 hours (n=0,0,0,0,7)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    4010 ( 31.6 )
        Cycle 2, Day 5: 24 hours (n=0,0,0,0,7)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    2380 ( 27.2 )
        Cycle 4, Day 1: 0 hours (n=0,0,0,0,4)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0 ( 0 )
        Cycle 4, Day 1: 6 hours (n=0,0,0,0,4)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    2730 ( 9.9 )
        Cycle 4, Day 5: 0 hours (n=0,0,0,0,3)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    2600 ( 25.6 )
        Cycle 4, Day 5: 6 hours (n=0,0,0,0,3)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    5210 ( 19.5 )
        Cycle 4, Day 5: 24 hours (n=0,0,0,0,3)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    2600 ( 25.6 )
    No statistical analyses for this end point

    Secondary: Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints

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    End point title
    		 Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints
    End point description
    End point type
    Secondary
    End point timeframe
    Pre-infusion (0 hour) and 0.5 hours after end of obinutuzumab infusion on Day 1 of Cycles 1, 2, 4, and 6
    End point values
    		 DLBCL/FL: Idasanutlin 100/150/200 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    17
    Units: micrograms per millilitre (μg/mL)
    geometric mean (geometric coefficient of variation)
        Cycle 1, Day 1: 0 hours (n=16)
    0 ( 0 )
        Cycle 1, Day 1: 0.5 hours (n=13)
    397 ( 32.9 )
        Cycle 2, Day 1: 0 hours (n=12)
    325 ( 59.8 )
        Cycle 2, Day 1: 0.5 hours (n=12)
    703 ( 40.2 )
        Cycle 4, Day 1: 0 hours (n=7)
    346 ( 46.1 )
        Cycle 4, Day 1: 0.5 hours (n=7)
    685 ( 38.5 )
        Cycle 6, Day 1: 0 hours (n=7)
    303 ( 49.5 )
        Cycle 6, Day 1: 0.5 hours (n=7)
    639 ( 34.2 )
    No statistical analyses for this end point

    Secondary: Serum Rituximab Concentrations in DLBCL Participants at Nominal Sampling Timepoints

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    End point title
    		 Serum Rituximab Concentrations in DLBCL Participants at Nominal Sampling Timepoints
    End point description
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 DLBCL Combined: Idasanutlin 150/200 mg + Rituximab 375 mg/m^2
    Number of subjects analysed
    7
    Units: micrograms per millilitre (μg/mL)
    geometric mean (geometric coefficient of variation)
        Cycle 1, Day 1: 0 hours (n=7)
    0 ( 0 )
        Cycle 1, Day 1: 0.5 hours (n=6)
    197 ( 14.1 )
        Cycle 2, Day 1: 0 hours (n=3)
    37.9 ( 58.1 )
    No statistical analyses for this end point

    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)

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    End point title
    		 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)
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    From first dose until 90 days after the last dose of study drug treatment (up to 31 months)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    1
    3
    2
    3
    4
    2
    4
    5
    Units: Participants
        Any Adverse Event (AE)
    1
    3
    2
    3
    4
    2
    4
    5
        Grade 5 AE
    0
    0
    0
    0
    0
    0
    0
    0
        Grade 3-5 AE
    1
    3
    2
    2
    3
    1
    3
    4
        Serious AE
    1
    1
    1
    0
    2
    1
    1
    2
        AE Leading to any Study Treatment Discontinuation
    0
    1
    2
    1
    1
    0
    2
    2
        AE Leading to Dose Reductions
    0
    0
    0
    0
    0
    0
    0
    0
        AE Leading to Dose Interruptions
    1
    0
    0
    0
    1
    0
    3
    1
        AE Leading to Study Discontinuation
    0
    0
    0
    0
    0
    0
    0
    0
        Related to Idasanutlin - Any AE
    1
    2
    2
    2
    4
    1
    4
    5
        Related to Idasanutlin - Grade 3-5 AE
    1
    2
    2
    1
    2
    1
    3
    4
        Related to Idasanutlin - Serious AE
    1
    0
    1
    0
    1
    0
    0
    2
        Related to Obinutuzumab - Any AE
    1
    2
    2
    0
    1
    0
    3
    5
        Related to Obinutuzumab - Grade 3-5 AE
    1
    1
    2
    0
    0
    0
    2
    3
        Related to Obinutuzumab - Serious AE
    0
    0
    1
    0
    0
    0
    1
    1
        Related to Rituximab - Any AE
    0
    0
    0
    2
    2
    0
    0
    0
        Related to Rituximab - Grade 3-5 AE
    0
    0
    0
    1
    0
    0
    0
    0
        Related to Rituximab - Serious AE
    0
    0
    0
    0
    0
    0
    0
    0
        Related AE Leading to Treatment Discontinuation
    0
    0
    2
    1
    1
    0
    2
    1
    No statistical analyses for this end point

    Secondary: Baseline Value and Change from Baseline Values of Systolic Blood Pressure at Specified Timepoints

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    End point title
    		 Baseline Value and Change from Baseline Values of Systolic Blood Pressure at Specified Timepoints
    End point description
    Vital signs were measured prior to the infusion while the participant was in a seated position. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The value '999999' in the results table indicates that the mean and standard deviation are not available because 0 participants were analyzed at a given timepoint. The value '9999999' in the results table indicates that the standard deviation could not be calculated using data from a single participant. Maint. = maintenance
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    1
    3
    2
    3
    4
    2
    4
    5
    Units: millimeters of mercury (mmHg)
    arithmetic mean (standard deviation)
        Baseline (BL) Value at Visit (n=1,3,2,3,4,2,4,5)
    176.0 ( 9999999 )
    124.0 ( 7.9 )
    107.5 ( 2.1 )
    125.7 ( 39.4 )
    119.0 ( 16.8 )
    120.5 ( 17.7 )
    109.3 ( 9.1 )
    116.4 ( 10.5 )
        Change from BL: Cycle 1 Day 1 (n=1,3,2,3,4,2,4,5)
    -34.0 ( 9999999 )
    -2.0 ( 10.5 )
    -5.0 ( 4.2 )
    -2.7 ( 14.6 )
    -0.8 ( 10.6 )
    -3.5 ( 10.6 )
    3.5 ( 9.4 )
    4.8 ( 14.8 )
        Change from BL: Cycle 1 Day 8 (n=1,3,2,0,0,2,4,5)
    -4.0 ( 9999999 )
    -5.0 ( 8.5 )
    -7.0 ( 8.5 )
    999999 ( 999999 )
    999999 ( 999999 )
    -6.5 ( 6.4 )
    -2.3 ( 15.2 )
    6.4 ( 10.3 )
        Change from BL: Cycle 1 Day 15 (n=1,3,0,0,0,2,3,5)
    24.0 ( 9999999 )
    -5.3 ( 14.6 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -3.5 ( 7.8 )
    9.7 ( 13.4 )
    8.0 ( 12.9 )
        Change from BL: Cycle 2 Day 1 (n=1,2,0,2,0,1,2,5)
    -17.0 ( 9999999 )
    -3.5 ( 19.1 )
    999999 ( 999999 )
    0.0 ( 39.6 )
    999999 ( 999999 )
    -14.0 ( 9999999 )
    4.5 ( 4.9 )
    8.6 ( 10.4 )
        Change from BL: Cycle 3 Day 1 (n=1,1,0,0,0,2,2,3)
    -1.0 ( 9999999 )
    11.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -13.5 ( 3.5 )
    10.5 ( 2.1 )
    7.0 ( 8.9 )
        Change from BL: Cycle 4 Day 1 (n=1,0,0,0,0,2,2,1)
    -22.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    12.5 ( 27.6 )
    2.0 ( 1.4 )
    -10.0 ( 9999999 )
        Change from BL: Cycle 5 Day 1 (n=1,0,0,0,0,2,2,2)
    -21.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.5 ( 4.9 )
    12.5 ( 9.2 )
    8.5 ( 9.2 )
        Change from BL: Cycle 6 Day 1 (n=0,0,0,0,0,1,1,2)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -2.0 ( 9999999 )
    20.0 ( 9999999 )
    0.5 ( 0.7 )
        Change from BL: Maint. Month 1 (n=0,0,0,0,0,1,0,2)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -14.0 ( 9999999 )
    999999 ( 999999 )
    14.0 ( 9.9 )
        Change from BL: Maint. Month 3 (n=0,0,0,0,0,1,0,2)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    9.0 ( 9999999 )
    999999 ( 999999 )
    7.5 ( 10.6 )
        Change from BL: Maint. Month 5 (n=0,0,0,0,0,1,0,1)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -12.0 ( 9999999 )
    999999 ( 999999 )
    9.0 ( 9999999 )
        Change from BL: Maint. Month 7 (n=0,0,0,0,0,1,0,1)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -5.0 ( 9999999 )
    999999 ( 999999 )
    0.0 ( 9999999 )
        Change from BL: Maint. Month 9 (n=0,0,0,0,0,1,0,1)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -3.0 ( 9999999 )
    999999 ( 999999 )
    7.0 ( 9999999 )
        Change from BL: Maint. Month 11(n=0,0,0,0,0,1,0,0)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -5.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL: Maint. Month 13(n=0,0,0,0,0,1,0,0)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -5.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL: Maint. Month 15(n=0,0,0,0,0,1,0,0)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -9.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL: Maint. Month 17(n=0,0,0,0,0,1,0,0)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -35.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL: Maint. Month 19(n=0,0,0,0,0,1,0,0)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    2.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL: Maint. Month 21(n=0,0,0,0,0,1,0,0)
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -21.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL: Follow-Up (n=1,0,2,2,2,2,4,4)
    -32.0 ( 9999999 )
    999999 ( 999999 )
    -3.5 ( 9.2 )
    -25.0 ( 55.2 )
    -3.5 ( 0.7 )
    9.5 ( 3.5 )
    20.0 ( 15.5 )
    -1.3 ( 9.0 )
    No statistical analyses for this end point

    Secondary: Baseline Value and Change from Baseline Values of Diastolic Blood Pressure at Specified Timepoints

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    End point title
    		 Baseline Value and Change from Baseline Values of Diastolic Blood Pressure at Specified Timepoints
    End point description
    Vital signs were measured prior to the infusion while the participant was in a seated position. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The value '999999' in the results table indicates that the mean and standard deviation are not available because 0 participants were analyzed at a given timepoint. The value '9999999' in the results table indicates that the standard deviation could not be calculated using data from a single participant. Maint. = maintenance
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    1
    3
    2
    3
    4
    2
    4
    5
    Units: millimeters of mercury (mmHg)
    arithmetic mean (standard deviation)
        Baseline (BL) Value at Visit
    100.0 ( 9999999 )
    67.3 ( 12.1 )
    72.0 ( 9.9 )
    72.3 ( 12.3 )
    70.3 ( 7.6 )
    71.5 ( 9.2 )
    76.3 ( 12.7 )
    65.8 ( 6.9 )
        Change from BL at Cycle 1 Day 1
    -17.0 ( 9999999 )
    -2.0 ( 19.5 )
    -2.5 ( 2.1 )
    7.3 ( 23.1 )
    -2.3 ( 7.4 )
    -2.0 ( 4.2 )
    3.0 ( 4.9 )
    6.4 ( 2.1 )
        Change from BL at Cycle 1 Day 8
    -1.0 ( 9999999 )
    1.3 ( 15.0 )
    -2.5 ( 6.4 )
    999999 ( 999999 )
    999999 ( 999999 )
    -2.0 ( 0.0 )
    -6.5 ( 1.3 )
    9.2 ( 8.5 )
        Change from BL at Cycle 1 Day 15
    -1.0 ( 9999999 )
    3.0 ( 16.4 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    6.0 ( 4.2 )
    0.0 ( 6.6 )
    2.4 ( 8.3 )
        Change from BL at Cycle 2 Day 1
    7.0 ( 9999999 )
    0.0 ( 17.0 )
    999999 ( 999999 )
    3.5 ( 13.4 )
    999999 ( 999999 )
    0.0 ( 9999999 )
    -8.0 ( 2.8 )
    12.0 ( 5.1 )
        Change from BL at Cycle 3 Day 1
    3.0 ( 9999999 )
    3.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -5.5 ( 6.4 )
    -1.0 ( 4.2 )
    5.3 ( 5.0 )
        Change from BL at Cycle 4 Day 1
    -4.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    3.0 ( 8.5 )
    -8.0 ( 7.1 )
    7.0 ( 9999999 )
        Change from BL at Cycle 5 Day 1
    -2.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    3.5 ( 0.7 )
    -2.0 ( 7.1 )
    2.5 ( 4.9 )
        Change from BL at Cycle 6 Day 1
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    10.0 ( 9999999 )
    9.0 ( 9999999 )
    2.5 ( 3.5 )
        Change from BL at Maint. Month 1
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.0 ( 9999999 )
    999999 ( 999999 )
    2.0 ( 0.0 )
        Change from BL at Maint. Month 3
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    14.0 ( 9999999 )
    999999 ( 999999 )
    5.0 ( 8.5 )
        Change from BL at Maint. Month 5
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -7.0 ( 9999999 )
    999999 ( 999999 )
    -5.0 ( 9999999 )
        Change from BL at Maint. Month 7
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    7.0 ( 9999999 )
    999999 ( 999999 )
    -1.0 ( 9999999 )
        Change from BL at Maint. Month 9
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    6.0 ( 9999999 )
    999999 ( 999999 )
    3.0 ( 9999999 )
        Change from BL at Maint. Month 11
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -13.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 13
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    1.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 15
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    9.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 17
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -4.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 19
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    7.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 21
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Follow-Up
    -16.0 ( 9999999 )
    999999 ( 999999 )
    -9.0 ( 21.2 )
    -15.5 ( 20.5 )
    4.0 ( 4.2 )
    10.5 ( 2.1 )
    7.5 ( 20.2 )
    9.3 ( 3.3 )
    No statistical analyses for this end point

    Secondary: Baseline Value and Change from Baseline Values of Pulse Rate at Specified Timepoints

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    End point title
    		 Baseline Value and Change from Baseline Values of Pulse Rate at Specified Timepoints
    End point description
    Vital signs were measured prior to the infusion while the participant was in a seated position. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The value '999999' in the results table indicates that the mean and standard deviation are not available because 0 participants were analyzed at a given timepoint. The value '9999999' in the results table indicates that the standard deviation could not be calculated using data from a single participant. Maint. = maintenance
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    1
    3
    2
    3
    4
    2
    4
    5
    Units: beats per minute
    arithmetic mean (standard deviation)
        Baseline (BL) - Value at Visit
    73.0 ( 9999999 )
    65.7 ( 1.2 )
    100.5 ( 17.7 )
    81.7 ( 3.1 )
    76.0 ( 10.6 )
    77.5 ( 12.0 )
    79.5 ( 18.6 )
    80.2 ( 9.9 )
        Change from BL at Cycle 1 Day 1
    10.0 ( 9999999 )
    15.7 ( 21.5 )
    -9.0 ( 8.5 )
    0.0 ( 9.8 )
    8.8 ( 12.0 )
    2.5 ( 14.8 )
    2.3 ( 6.4 )
    9.0 ( 11.1 )
        Change from BL at Cycle 1 Day 8
    -2.0 ( 9999999 )
    11.0 ( 2.0 )
    -2.0 ( 1.4 )
    999999 ( 999999 )
    999999 ( 999999 )
    -0.5 ( 20.5 )
    2.3 ( 6.4 )
    9.0 ( 11.1 )
        Change from BL at Cycle 1 Day 15
    -11.0 ( 9999999 )
    12.7 ( 13.4 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -3.5 ( 16.3 )
    -1.7 ( 13.1 )
    3.2 ( 14.5 )
        Change from BL at Cycle 2 Day 1
    4.0 ( 9999999 )
    17.5 ( 17.7 )
    999999 ( 999999 )
    7.0 ( 1.4 )
    999999 ( 999999 )
    -17.0 ( 9999999 )
    -2.5 ( 4.9 )
    6.4 ( 9.7 )
        Change from BL at Cycle 3 Day 1
    -1.0 ( 9999999 )
    19.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -1.5 ( 16.3 )
    -4.5 ( 20.5 )
    -3.5 ( 10.6 )
        Change from BL at Cycle 4 Day 1
    1.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -7.0 ( 12.7 )
    -5.0 ( 5.7 )
    4.0 ( 9999999 )
        Change from BL at Cycle 5 Day 1
    15.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -6.5 ( 10.6 )
    3.0 ( 28.3 )
    6.5 ( 4.9 )
        Change from BL at Cycle 6 Day 1
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -1.0 ( 9999999 )
    31.0 ( 9999999 )
    15.0 ( 2.8 )
        Change from BL at Maint. Month 1
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    6.0 ( 9999999 )
    999999 ( 999999 )
    10.0 ( 5.7 )
        Change from BL at Maint. Month 3
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.0 ( 9999999 )
    999999 ( 999999 )
    2.0 ( 9.9 )
        Change from BL at Maint. Month 5
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -5.0 ( 9999999 )
    999999 ( 999999 )
    11.0 ( 9999999 )
        Change from BL at Maint. Month 7
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    1.0 ( 9999999 )
    999999 ( 999999 )
    2.0 ( 9999999 )
        Change from BL at Maint. Month 9
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    6.0 ( 9999999 )
    999999 ( 999999 )
    11.0 ( 9999999 )
        Change from BL at Maint. Month 11
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    18.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 13
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    11.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 15
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    2.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 17
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -2.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 19
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    1.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 21
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    13.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Follow-Up
    15.0 ( 9999999 )
    999999 ( 999999 )
    -20.0 ( 18.4 )
    11.5 ( 10.6 )
    23.5 ( 20.5 )
    15.0 ( 8.5 )
    5.8 ( 14.8 )
    10.3 ( 9.2 )
    No statistical analyses for this end point

    Secondary: Baseline Value and Change from Baseline Values of Respiratory Rate at Specified Timepoints

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    End point title
    		 Baseline Value and Change from Baseline Values of Respiratory Rate at Specified Timepoints
    End point description
    Vital signs were measured prior to the infusion while the participant was in a seated position. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The value '999999' in the results table indicates that the mean and standard deviation are not available because 0 participants were analyzed at a given timepoint. The value '9999999' in the results table indicates that the standard deviation could not be calculated using data from a single participant. Maint. = maintenance
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    1
    3
    2
    3
    4
    2
    4
    5
    Units: breaths per minute
    arithmetic mean (standard deviation)
        Baseline (BL) - Value at Visit
    18.0 ( 9999999 )
    17.0 ( 2.6 )
    19.0 ( 1.4 )
    17.0 ( 1.7 )
    17.0 ( 2.0 )
    16.0 ( 0.0 )
    16.0 ( 3.3 )
    16.8 ( 3.0 )
        Change from BL at Cycle 1 Day 1
    0.0 ( 9999999 )
    0.7 ( 1.2 )
    -1.0 ( 1.4 )
    -0.7 ( 1.2 )
    0.3 ( 1.3 )
    1.0 ( 1.4 )
    2.3 ( 0.5 )
    0.0 ( 0.0 )
        Change from BL at Cycle 1 Day 8
    0.0 ( 9999999 )
    -1.7 ( 2.1 )
    -1.0 ( 1.4 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.0 ( 0.0 )
    2.0 ( 4.0 )
    0.0 ( 2.4 )
        Change from BL at Cycle 1 Day 15
    0.0 ( 9999999 )
    -3.5 ( 2.1 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    1.0 ( 1.4 )
    1.7 ( 1.5 )
    -0.2 ( 2.7 )
        Change from BL at Cycle 2 Day 1
    0.0 ( 9999999 )
    -2.5 ( 3.5 )
    999999 ( 999999 )
    0.5 ( 0.7 )
    999999 ( 999999 )
    0.0 ( 9999999 )
    4.0 ( 5.7 )
    0.0 ( 4.6 )
        Change from BL at Cycle 3 Day 1
    2.0 ( 9999999 )
    -4.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.0 ( 0.0 )
    4.0 ( 5.7 )
    -1.0 ( 4.2 )
        Change from BL at Cycle 4 Day 1
    -2.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.0 ( 0.0 )
    2.0 ( 2.8 )
    4.0 ( 9999999 )
        Change from BL at Cycle 5 Day 1
    0.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.0 ( 0.0 )
    1.0 ( 1.4 )
    0.0 ( 5.7 )
        Change from BL at Cycle 6 Day 1
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -4.0 ( 9999999 )
    5.0 ( 9999999 )
    -2.0 ( 2.8 )
        Change from BL at Maint. Month 1
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -4.0 ( 9999999 )
    999999 ( 999999 )
    -1.0 ( 4.2 )
        Change from BL at Maint. Month 3
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.0 ( 9999999 )
    999999 ( 999999 )
    -2.0 ( 2.8 )
        Change from BL at Maint. Month 5
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.0 ( 9999999 )
    999999 ( 999999 )
    -4.0 ( 9999999 )
        Change from BL at Maint. Month 7
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.0 ( 9999999 )
    999999 ( 999999 )
    -4.0 ( 9999999 )
        Change from BL at Maint. Month 9
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    2.0 ( 9999999 )
    999999 ( 999999 )
    -4.0 ( 9999999 )
        Change from BL at Maint. Month 11
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 13
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 15
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 17
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    2.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 19
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 21
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    2.0 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Follow-Up
    -2.0 ( 9999999 )
    999999 ( 999999 )
    -2.0 ( 2.8 )
    -4.0 ( 9999999 )
    0.0 ( 2.8 )
    1.0 ( 1.4 )
    3.3 ( 3.2 )
    -0.7 ( 3.1 )
    No statistical analyses for this end point

    Secondary: Baseline Value and Change from Baseline Values of Body Temperature at Specified Timepoints

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    End point title
    		 Baseline Value and Change from Baseline Values of Body Temperature at Specified Timepoints
    End point description
    Vital signs were measured prior to the infusion while the participant was in a seated position. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The value '999999' in the results table indicates that the mean and standard deviation are not available because 0 participants were analyzed at a given timepoint. The value '9999999' in the results table indicates that the standard deviation could not be calculated using data from a single participant. Maint. = maintenance
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    1
    3
    2
    3
    4
    2
    4
    5
    Units: degrees Celsius (C)
    arithmetic mean (standard deviation)
        Baseline (BL) - Value at Visit
    36.60 ( 9999999 )
    36.47 ( 0.45 )
    36.35 ( 0.21 )
    36.83 ( 0.15 )
    36.58 ( 0.34 )
    36.55 ( 0.21 )
    36.50 ( 0.18 )
    36.70 ( 3.3 )
        Change from BL at Cycle 1 Day 1
    0.00 ( 9999999 )
    0.00 ( 0.92 )
    -0.15 ( 0.21 )
    -0.07 ( 0.15 )
    0.18 ( 0.33 )
    0.05 ( 0.49 )
    0.30 ( 0.22 )
    -0.18 ( 0.30 )
        Change from BL at Cycle 1 Day 8
    0.10 ( 9999999 )
    0.37 ( 0.50 )
    0.95 ( 0.85 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.30 ( 0.28 )
    -0.13 ( 0.22 )
    0.10 ( 0.45 )
        Change from BL at Cycle 1 Day 15
    0.10 ( 9999999 )
    0.20 ( 0.82 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.20 ( 0.28 )
    -0.23 ( 0.45 )
    -0.18 ( 0.26 )
        Change from BL at Cycle 2 Day 1
    0.00 ( 9999999 )
    0.10 ( 0.14 )
    999999 ( 999999 )
    -0.30 ( 0.14 )
    999999 ( 999999 )
    -0.50 ( 9999999 )
    -0.25 ( 0.49 )
    -0.04 ( 0.09 )
        Change from BL at Cycle 3 Day 1
    -0.20 ( 9999999 )
    -0.10 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    -0.10 ( 0.42 )
    -0.50 ( 0.28 )
    -0.17 ( 0.21 )
        Change from BL at Cycle 4 Day 1
    0.00 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.05 ( 0.64 )
    0.05 ( 0.21 )
    -0.10 ( 9999999 )
        Change from BL at Cycle 5 Day 1
    0.20 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.35 ( 0.64 )
    -0.35 ( 0.49 )
    -0.20 ( 0.14 )
        Change from BL at Cycle 6 Day 1
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.20 ( 9999999 )
    0.20 ( 9999999 )
    -0.05 ( 0.21 )
        Change from BL at Maint. Month 1
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.60 ( 9999999 )
    999999 ( 999999 )
    -0.20 ( 0.14 )
        Change from BL at Maint. Month 3
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.40 ( 9999999 )
    999999 ( 999999 )
    -0.20 ( 0.57 )
        Change from BL at Maint. Month 5
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.20 ( 9999999 )
    999999 ( 999999 )
    -0.20 ( 9999999 )
        Change from BL at Maint. Month 7
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.60 ( 9999999 )
    999999 ( 999999 )
    -0.10 ( 9999999 )
        Change from BL at Maint. Month 9
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.30 ( 9999999 )
    999999 ( 999999 )
    0.20 ( 9999999 )
        Change from BL at Maint. Month 11
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.70 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 13
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.40 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 15
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.70 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 17
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.40 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 19
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.80 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Maint. Month 21
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    999999 ( 999999 )
    0.50 ( 9999999 )
    999999 ( 999999 )
    999999 ( 999999 )
        Change from BL at Follow-Up
    0.10 ( 9999999 )
    999999 ( 999999 )
    0.00 ( 0.14 )
    -0.40 ( 0.14 )
    0.53 ( 0.71 )
    0.30 ( 0.57 )
    -0.15 ( 0.47 )
    -0.10 ( 0.24 )
    No statistical analyses for this end point

    Secondary: Number of Participants by Electrocardiogram (ECG) Results Assessment Shift from Baseline to Specified Post-Baseline Timepoints

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    End point title
    		 Number of Participants by Electrocardiogram (ECG) Results Assessment Shift from Baseline to Specified Post-Baseline Timepoints
    End point description
    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. The value '999999' indicates that data is not available because 0 participants were analyzed. Abnorm, CS = Abnormal, Clinically Significant; Abnorm, not CS = Abnormal, not Clinically Significant; BL = baseline; C1D1 = Induction Cycle 1 Day 1; C4D1 = Induction Cycle 4 Day 1; EOI = End of Induction Treatment - Completion/Discontinuation; EOM = End of Maintenance Treatment - Completion/Discontinuation; M1 = Maintenance Month 1; U = Unscheduled Visit
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    1
    3
    2
    3
    4
    2
    4
    5
    Units: Participants
        C1D1: Norm at BL & Visit (n=0,3,2,3,4,1,4,5)
    999999
    1
    1
    0
    2
    0
    4
    2
        C1D1:Norm(BL) to Abnorm,not CS (n=0,3,2,3,4,1,4,5)
    999999
    1
    0
    1
    0
    0
    0
    0
        C1D1:Abnorm,not CS(BL) to Norm (n=0,3,2,3,4,1,4,5)
    999999
    0
    0
    1
    0
    0
    0
    1
        C1D1:Abnorm,not CS at BL&Visit (n=0,3,2,3,4,1,4,5)
    999999
    1
    1
    1
    2
    1
    0
    2
        C4D1: Norm at BL & Visit (n=1,0,0,0,0,2,2,2)
    0
    999999
    999999
    999999
    999999
    0
    2
    1
        C4D1:Norm(BL) to Abnorm, not CS(n=1,0,0,0,0,2,2,2)
    1
    999999
    999999
    999999
    999999
    0
    0
    0
        C4D1:Abnorm, not CS(BL) to Norm(n=1,0,0,0,0,2,2,2)
    0
    999999
    999999
    999999
    999999
    0
    0
    1
        C4D1:Abnorm,not CS at BL&Visit (n=1,0,0,0,0,2,2,2)
    0
    999999
    999999
    999999
    999999
    1
    0
    0
        C4D1:Missing (BL) to Norm (n=1,0,0,0,0,2,2,2)
    0
    999999
    999999
    999999
    999999
    1
    0
    0
        EOI: Norm at BL & Visit (n=1,2,2,1,3,2,3,3)
    0
    0
    1
    0
    2
    0
    3
    2
        EOI:Norm(BL) to Abnorm,not CS (n=1,2,2,1,3,2,3,3)
    1
    1
    0
    0
    0
    0
    0
    0
        EOI:Abnorm,not CS at BL&Visit (n=1,2,2,1,3,2,3,3)
    0
    1
    1
    1
    1
    1
    0
    1
        EOI: Missing (BL) to Norm (n=1,2,2,1,3,2,3,3)
    0
    0
    0
    0
    0
    1
    0
    0
        M1: Norm at BL & Visit (n=0,0,0,0,0,0,0,2)
    999999
    999999
    999999
    999999
    999999
    999999
    999999
    1
        M1: Abnorm,not CS at BL&Visit (n=0,0,0,0,0,0,0,2)
    999999
    999999
    999999
    999999
    999999
    999999
    999999
    1
        M3: Abnorm, not CS(BL) to Norm (n=0,0,0,0,0,0,0,1)
    999999
    999999
    999999
    999999
    999999
    999999
    999999
    1
        M5: Abnorm, not CS(BL) to Norm (n=0,0,0,0,0,0,0,1)
    999999
    999999
    999999
    999999
    999999
    999999
    999999
    1
        M7:Missing(BL) to Abnorm,notCS(n=0,0,0,0,0,1,0,0)
    999999
    999999
    999999
    999999
    999999
    1
    999999
    999999
        M9:Missing(BL) to Abnorm,notCS(n=0,0,0,0,0,1,0,0)
    999999
    999999
    999999
    999999
    999999
    1
    999999
    999999
        M11:Missing(BL) to Abnorm,notCS(n=0,0,0,0,0,1,0,0)
    999999
    999999
    999999
    999999
    999999
    1
    999999
    999999
        M13:Missing(BL) to Abnorm,notCS(n=0,0,0,0,0,1,0,0)
    999999
    999999
    999999
    999999
    999999
    1
    999999
    999999
        M15:Missing(BL) to Abnorm,notCS(n=0,0,0,0,0,1,0,0)
    999999
    999999
    999999
    999999
    999999
    1
    999999
    999999
        M17:Missing(BL) to Abnorm,notCS(n=0,0,0,0,0,1,0,0)
    999999
    999999
    999999
    999999
    999999
    1
    999999
    999999
        M19:Missing(BL) to Abnorm,notCS(n=0,0,0,0,0,1,0,0)
    999999
    999999
    999999
    999999
    999999
    1
    999999
    999999
        M21:Missing(BL) to Abnorm,notCS(n=0,0,0,0,0,1,0,0)
    999999
    999999
    999999
    999999
    999999
    1
    999999
    999999
        M23:Missing(BL) to Abnorm,notCS(n=0,0,0,0,0,1,0,0)
    999999
    999999
    999999
    999999
    999999
    1
    999999
    999999
        EOM: Norm at BL & Visit (n=0,0,0,0,0,1,1,0)
    999999
    999999
    999999
    999999
    999999
    0
    1
    999999
        EOM:Missing(BL) to Abnorm,notCS(n=0,0,0,0,0,1,1,0)
    999999
    999999
    999999
    999999
    999999
    1
    0
    999999
        U: Norm at BL & Visit (n=1,0,0,0,0,1,2,2)
    1
    999999
    999999
    999999
    999999
    0
    1
    0
        U:Norm (BL) to Abnorm, not CS (n=1,0,0,0,0,1,2,2)
    0
    999999
    999999
    999999
    999999
    0
    1
    0
        U:Abnorm, not CS(BL) to Norm (n=1,0,0,0,0,1,2,2)
    0
    999999
    999999
    999999
    999999
    0
    0
    1
        U:Abnorm,not CS at BL&Visit (n=1,0,0,0,0,1,2,2)
    0
    999999
    999999
    999999
    999999
    1
    0
    0
        U:Abnorm,notCS(BL) to Abnorm,CS(n=1,0,0,0,0,1,2,2)
    0
    999999
    999999
    999999
    999999
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline

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    End point title
    		 Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline
    End point description
    Clinical laboratory tests for hematology parameters were performed at local laboratories and abnormalities (High or Low) were based on local reference ranges. Severity was determined according to NCI-CTCAE v4.0, from Grades 1 (least severe) to 4 (most severe). Grade 0 indicates that the results were within the normal range. 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 multiple post-baseline abnormalities on any given parameter, only the participant’s highest grade was reported. Abs. = absolute count; BL = baseline; WBC = white blood cell count
    End point type
    Secondary
    End point timeframe
    From Baseline until 35 days after the last dose of study drug (up to 29 months)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    1
    3
    2
    3
    4
    2
    4
    5
    Units: Participants
        Hemoglobin (g/L), High: Grade (Gr.) 0 (BL) to 0
    1
    3
    2
    3
    4
    2
    4
    5
        Hemoglobin (g/L), Low: Gr. 0 (BL) to 0
    0
    0
    0
    0
    0
    1
    0
    1
        Hemoglobin (g/L), Low: Gr. 0 (BL) to 2
    0
    0
    0
    0
    0
    1
    2
    0
        Hemoglobin (g/L), Low: Gr. 0 (BL) to 3
    0
    0
    0
    0
    0
    0
    1
    0
        Hemoglobin (g/L), Low: Gr. 1 (BL) to 1
    0
    2
    0
    2
    3
    0
    1
    1
        Hemoglobin (g/L), Low: Gr. 1 (BL) to 2
    0
    1
    1
    0
    0
    0
    0
    2
        Hemoglobin (g/L), Low: Gr. 1 (BL) to 3
    0
    0
    1
    0
    0
    0
    0
    0
        Hemoglobin (g/L), Low: Gr. 2 (BL) to 2
    1
    0
    0
    0
    1
    0
    0
    0
        Hemoglobin (g/L), Low: Gr. 2 (BL) to 3
    0
    0
    0
    0
    0
    0
    0
    1
        Hemoglobin (g/L), Low: Gr. 3 (BL) to 3
    0
    0
    0
    1
    0
    0
    0
    0
        Lymphocytes Abs. (10^9/L), High: Gr. 0 (BL) to 0
    1
    3
    2
    3
    4
    2
    4
    5
        Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 0
    0
    0
    0
    0
    1
    0
    1
    1
        Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 1
    0
    0
    0
    1
    0
    0
    0
    0
        Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 2
    1
    0
    0
    1
    2
    0
    1
    0
        Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 3
    0
    0
    1
    0
    0
    0
    2
    0
        Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 4
    0
    0
    0
    0
    0
    1
    0
    0
        Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 0
    0
    0
    0
    0
    0
    0
    0
    1
        Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 1
    0
    0
    0
    0
    0
    0
    0
    0
        Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 3
    0
    0
    1
    0
    1
    0
    0
    0
        Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 2
    0
    0
    0
    0
    0
    1
    0
    0
        Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 4
    0
    1
    0
    0
    0
    0
    0
    1
        Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 2
    0
    1
    0
    0
    0
    0
    0
    0
        Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 3
    0
    0
    0
    1
    0
    0
    0
    1
        Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 4
    0
    1
    0
    0
    0
    0
    0
    0
        Lymphocytes Abs. (10^9/L), Low: Gr. 4 (BL) to 4
    0
    0
    0
    0
    0
    0
    0
    1
        Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 0
    0
    2
    0
    2
    2
    0
    1
    2
        Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 1
    0
    0
    0
    0
    1
    0
    0
    0
        Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 2
    0
    1
    0
    0
    0
    1
    0
    1
        Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 3
    1
    0
    0
    1
    1
    0
    0
    1
        Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 4
    0
    0
    2
    0
    0
    1
    2
    1
        Neutrophils,Total Abs (10^9/L),Low: Gr. 2(BL) to 4
    0
    0
    0
    0
    0
    0
    1
    0
        Platelets (10^9/L), Low: Gr. 0 (BL) to 0
    0
    0
    0
    1
    0
    0
    0
    0
        Platelets (10^9/L), Low: Gr. 0 (BL) to 1
    0
    1
    0
    1
    1
    1
    1
    1
        Platelets (10^9/L), Low: Gr. 0 (BL) to 2
    0
    0
    0
    0
    1
    0
    0
    0
        Platelets (10^9/L), Low: Gr. 0 (BL) to 3
    1
    1
    0
    0
    0
    0
    0
    0
        Platelets (10^9/L), Low: Gr. 0 (BL) to 4
    0
    0
    2
    1
    2
    1
    2
    1
        Platelets (10^9/L), Low: Gr. 1 (BL) to 1
    0
    0
    0
    0
    0
    0
    0
    1
        Platelets (10^9/L), Low: Gr. 1 (BL) to 3
    0
    1
    0
    0
    0
    0
    0
    1
        Platelets (10^9/L), Low: Gr. 1 (BL) to 4
    0
    0
    0
    0
    0
    0
    1
    1
        WBC (10^9/L), High: Gr. 0 (BL) to 0
    1
    3
    2
    3
    4
    2
    4
    5
        WBC (10^9/L), Low: Gr. 0 (BL) to 0
    0
    0
    0
    2
    2
    0
    0
    1
        WBC (10^9/L), Low: Gr. 0 (BL) to 1
    0
    0
    0
    0
    0
    0
    1
    2
        WBC (10^9/L), Low: Gr. 0 (BL) to 2
    1
    2
    0
    1
    0
    1
    1
    0
        WBC (10^9/L), Low: Gr. 0 (BL) to 3
    0
    0
    2
    0
    1
    0
    1
    0
        WBC (10^9/L), Low: Gr. 0 (BL) to 4
    0
    0
    0
    0
    0
    1
    0
    1
        WBC (10^9/L), Low: Gr. 1 (BL) to 0
    0
    1
    0
    0
    0
    0
    0
    0
        WBC (10^9/L), Low: Gr. 1 (BL) to 1
    0
    0
    0
    0
    1
    0
    0
    0
        WBC (10^9/L), Low: Gr. 1 (BL) to 2
    0
    0
    0
    0
    0
    0
    0
    1
        WBC (10^9/L), Low: Gr. 1 (BL) to 3
    0
    0
    0
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    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

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    End point title
    		 Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline
    End point description
    Clinical laboratory tests for blood chemistry parameters were performed at local laboratories and abnormalities (High or Low) were based on local reference ranges. Severity was determined according to NCI-CTCAE v4.0, from Grades 1 (least severe) to 4 (most severe). Grade 0 indicates that results were within the normal range. 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 multiple post-baseline abnormalities on any given parameter, only the participant’s highest grade was 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
    End point type
    Secondary
    End point timeframe
    From Baseline until 35 days after the last dose of study drug (up to 29 months)
    End point values
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Number of subjects analysed
    1
    3
    2
    3
    4
    2
    4
    5
    Units: Participants
        Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 0
    1
    3
    2
    1
    2
    2
    4
    3
        Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 1
    0
    0
    0
    1
    0
    0
    0
    0
        Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 2
    0
    0
    0
    0
    1
    0
    0
    1
        Albumin (g/L), Low: Grade (Gr.) 1 (BL) to 1
    0
    0
    0
    1
    1
    0
    0
    1
        Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 0
    0
    3
    2
    2
    3
    1
    4
    3
        Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 1
    0
    0
    0
    0
    1
    1
    0
    1
        Alkaline Phosphatase (U/L), High: Gr. 1 (BL) to 1
    1
    0
    0
    1
    0
    0
    0
    1
        Amylase (U/L), High: Gr. 0 (BL) to 0
    1
    3
    2
    3
    1
    2
    3
    5
        Amylase (U/L), High: Missing (BL) to Gr. 0
    0
    0
    0
    0
    2
    0
    1
    0
        Amylase (U/L), High: Gr. 1 (BL) to 1
    0
    0
    0
    0
    1
    0
    0
    0
        Bilirubin (umol/L), High: Gr. 0 (BL) to 0
    1
    3
    2
    3
    4
    2
    3
    5
        Bilirubin (umol/L), High: Gr. 0 (BL) to 1
    0
    0
    0
    0
    0
    0
    1
    0
        Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 0
    0
    0
    0
    0
    0
    1
    1
    1
        Blood Gluc,Fast(mmol/L), High: Gr. 0(BL) to 1
    0
    0
    1
    0
    0
    0
    0
    0
        Blood Gluc,Fast(mmol/L), High: Gr. 1 (BL) to 1
    0
    0
    1
    0
    0
    0
    0
    0
        Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 2
    1
    0
    0
    0
    0
    0
    0
    0
        Blood Gluc.,Fast.(mmol/L), High: Missing (All)
    0
    3
    0
    3
    4
    1
    3
    4
        Blood Gluc,Fast(mmol/L), Low: Gr. 0 (BL) to 0
    0
    0
    2
    0
    0
    0
    0
    0
        Blood Gluc,Fast(mmol/L), Low: Missing(BL) to Gr 0
    1
    0
    0
    0
    0
    1
    1
    1
        Blood Gluc.,Fast.(mmol/L), Low: Missing (All)
    0
    3
    0
    3
    4
    1
    3
    4
        Calcium (mmol/L), High: Gr. 0 (BL) to 0
    1
    3
    2
    3
    3
    2
    4
    5
        Calcium (mmol/L), High: Gr. 1 (BL) to 0
    0
    0
    0
    0
    1
    0
    0
    0
        Calcium (mmol/L), Low: Gr. 0 (BL) to 0
    1
    2
    2
    2
    3
    2
    3
    4
        Calcium (mmol/L), Low: Gr. 0 (BL) to 1
    0
    1
    0
    0
    1
    0
    1
    0
        Calcium (mmol/L), Low: Gr. 0 (BL) to 2
    0
    0
    0
    1
    0
    0
    0
    0
        Calcium (mmol/L), Low: Gr. 1 (BL) to 1
    0
    0
    0
    0
    0
    0
    0
    1
        Creatinine (umol/L), High: Gr. 0 (BL) to 0
    0
    2
    0
    1
    0
    0
    2
    3
        Creatinine (umol/L), High: Gr. 0 (BL) to 1
    0
    1
    2
    2
    2
    2
    1
    1
        Creatinine (umol/L), High: Gr. 0 (BL) to 3
    0
    0
    0
    0
    0
    0
    0
    1
        Creatinine (umol/L), High: Gr. 1 (BL) to 0
    0
    0
    0
    0
    1
    0
    0
    0
        Creatinine (umol/L), High: Gr. 1 (BL) to 1
    1
    0
    0
    0
    0
    0
    1
    0
        Creatinine (umol/L), High: Gr. 1 (BL) to 2
    0
    0
    0
    0
    1
    0
    0
    0
        Glucose (mmol/L), High: Gr. 0 (BL) to 0
    0
    3
    0
    3
    4
    2
    4
    5
        Glucose (mmol/L), High: Missing (BL) to Gr. 0
    0
    0
    1
    0
    0
    0
    0
    0
        Glucose (mmol/L), High: Gr. 0 (BL) to 3
    1
    0
    0
    0
    0
    0
    0
    0
        Glucose (mmol/L), High: Missing (All)
    0
    0
    1
    0
    0
    0
    0
    0
        Glucose (mmol/L), Low: Gr. 0 (BL) to 0
    1
    2
    0
    2
    4
    2
    4
    4
        Glucose (mmol/L), Low: Missing (BL) to Gr. 0
    0
    0
    1
    0
    0
    0
    0
    0
        Glucose (mmol/L), Low: Gr. 0 (BL) to 1
    0
    1
    0
    1
    0
    0
    0
    1
        Glucose (mmol/L), Low: Missing (All)
    0
    0
    1
    0
    0
    0
    0
    0
        Phosphorus (mmol/L), Low: Gr. 0 (BL) to 0
    0
    2
    2
    1
    2
    0
    0
    2
        Phosphorus (mmol/L), Low: Missing (BL) to Gr. 0
    1
    1
    0
    1
    0
    0
    2
    1
        Phosphorus (mmol/L), Low: Missing (BL) to Gr. 2
    0
    0
    0
    0
    1
    0
    0
    0
        Phosphorus (mmol/L), Low: Missing (All)
    0
    0
    0
    1
    1
    1
    2
    2
        Potassium (mmol/L), High: Gr. 0 (BL) to 0
    0
    3
    2
    2
    4
    2
    4
    5
        Potassium (mmol/L), High: Gr. 0 (BL) to 1
    1
    0
    0
    1
    0
    0
    0
    0
        Potassium (mmol/L), Low: Gr. 0 (BL) to 0
    1
    2
    2
    3
    3
    2
    4
    3
        Potassium (mmol/L), Low: Gr. 0 (BL) to 2
    0
    0
    0
    0
    1
    0
    0
    0
        Potassium (mmol/L), Low: Gr. 2 (BL) to 0
    0
    1
    0
    0
    0
    0
    0
    0
        Potassium (mmol/L), Low: Gr. 2 (BL) to 2
    0
    0
    0
    0
    0
    0
    0
    2
        SGOT/AST (U/L), High: Gr. 0 (BL) to 0
    1
    2
    2
    2
    4
    2
    4
    5
        SGOT/AST (U/L), High: Gr. 1 (BL) to 0
    0
    1
    0
    1
    0
    0
    0
    0
        SGPT/ALT (U/L), High: Gr. 0 (BL) to 0
    1
    2
    1
    3
    2
    2
    4
    5
        SGPT/ALT (U/L), High: Gr. 1 (BL) to 0
    0
    1
    1
    0
    0
    0
    0
    0
        SGPT/ALT (U/L), High: Gr. 1 (BL) to 1
    0
    0
    0
    0
    2
    0
    0
    0
        Sodium (mmol/L), High: Gr. 0 (BL) to 0
    1
    3
    2
    3
    3
    2
    4
    4
        Sodium (mmol/L), High: Gr. 0 (BL) to 1
    0
    0
    0
    0
    0
    0
    0
    1
        Sodium (mmol/L), High: Gr. 1 (BL) to 0
    0
    0
    0
    0
    1
    0
    0
    0
        Sodium (mmol/L), Low: Gr. 0 (BL) to 0
    1
    3
    2
    2
    4
    2
    4
    3
        Sodium (mmol/L), Low: Gr. 0 (BL) to 1
    0
    0
    0
    1
    0
    0
    0
    0
        Sodium (mmol/L), Low: Gr. 0 (BL) to 3
    0
    0
    0
    0
    0
    0
    0
    1
        Sodium (mmol/L), Low: Gr. 1 (BL) to 0
    0
    0
    0
    0
    0
    0
    0
    1
        Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 0
    0
    3
    2
    3
    2
    1
    3
    4
        Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 1
    0
    0
    0
    0
    0
    1
    0
    0
        Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 3
    1
    0
    0
    0
    0
    0
    0
    0
        Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 0
    0
    0
    0
    0
    0
    0
    1
    1
        Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 2
    0
    0
    0
    0
    2
    0
    0
    0
        Uric Acid (umol/L), High: Gr. 0 (BL) to 0
    1
    3
    2
    3
    2
    2
    3
    4
        Uric Acid (umol/L), High: Missing(BL) to Gr. 0
    0
    0
    0
    0
    1
    0
    0
    0
        Uric Acid (umol/L), High: Gr. 0 (BL) to 3
    0
    0
    0
    0
    0
    0
    0
    1
        Uric Acid (umol/L), High: Gr. 3 (BL) to 3
    0
    0
    0
    0
    0
    0
    1
    0
        Uric Acid (umol/L), High: Gr. 4 (BL) to 3
    0
    0
    0
    0
    1
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose until 90 days after the last dose of study treatment (up to 31 months)
    Adverse event reporting additional description
    After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until 90 days after the last dose of study drug. After this period, only serious AEs related to prior study drug or Grade 3-4 infections were reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg
    Reporting group description
    		 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).

    Reporting group title
    DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Reporting group description
    		 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).

    Reporting group title
    DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg
    Reporting group description
    		 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).

    Reporting group title
    DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2
    Reporting group description
    		 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).

    Reporting group title
    DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2
    Reporting group description
    		 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).

    Reporting group title
    FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg
    Reporting group description
    		 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).

    Reporting group title
    FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Reporting group description
    		 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).

    Reporting group title
    FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Reporting group description
    		 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).

    Serious adverse events
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    1 / 3 (33.33%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    1 / 2 (50.00%)
    1 / 4 (25.00%)
    2 / 5 (40.00%)
         number of deaths (all causes)
    0
    1
    2
    2
    2
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Peripheral swelling
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    3 / 3 (100.00%)
    2 / 2 (100.00%)
    3 / 3 (100.00%)
    4 / 4 (100.00%)
    2 / 2 (100.00%)
    4 / 4 (100.00%)
    5 / 5 (100.00%)
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 1 (100.00%)
    1 / 3 (33.33%)
    1 / 2 (50.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    3 / 4 (75.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    1
    1
    0
    1
    8
    1
    Oedema
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    2 / 4 (50.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    3
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    2 / 5 (40.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    2
    Dyspnoea exertional
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Investigations
    Blood albumin decreased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Haemophilus test positive
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Lipase increased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    2 / 3 (66.67%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    1
    Dysgeusia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    1
    Memory impairment
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Taste disorder
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    2 / 2 (100.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    3 / 4 (75.00%)
    2 / 5 (40.00%)
         occurrences all number
    0
    0
    2
    1
    0
    2
    3
    3
    Leukopenia
         subjects affected / exposed
    0 / 1 (0.00%)
    2 / 3 (66.67%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    3
    0
    0
    1
    0
    2
    1
    Lymphopenia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    1
    1
    Neutropenia
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 3 (0.00%)
    2 / 2 (100.00%)
    1 / 3 (33.33%)
    4 / 4 (100.00%)
    1 / 2 (50.00%)
    3 / 4 (75.00%)
    3 / 5 (60.00%)
         occurrences all number
    1
    0
    3
    2
    4
    2
    10
    4
    Thrombocytopenia
         subjects affected / exposed
    1 / 1 (100.00%)
    2 / 3 (66.67%)
    2 / 2 (100.00%)
    1 / 3 (33.33%)
    2 / 4 (50.00%)
    2 / 2 (100.00%)
    4 / 4 (100.00%)
    4 / 5 (80.00%)
         occurrences all number
    1
    2
    2
    2
    2
    2
    7
    6
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    1 / 2 (50.00%)
    2 / 3 (66.67%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    3 / 4 (75.00%)
    3 / 5 (60.00%)
         occurrences all number
    0
    1
    2
    3
    0
    4
    8
    5
    Nausea
         subjects affected / exposed
    1 / 1 (100.00%)
    1 / 3 (33.33%)
    1 / 2 (50.00%)
    2 / 3 (66.67%)
    0 / 4 (0.00%)
    2 / 2 (100.00%)
    3 / 4 (75.00%)
    5 / 5 (100.00%)
         occurrences all number
    2
    1
    1
    2
    0
    6
    8
    11
    Constipation
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    2 / 5 (40.00%)
         occurrences all number
    0
    1
    0
    0
    1
    1
    0
    3
    Gastrointestinal pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 4 (50.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    0
    Abdominal pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Anal inflammation
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    Flatulence
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    1 / 2 (50.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    3 / 5 (60.00%)
         occurrences all number
    0
    1
    1
    1
    0
    0
    0
    4
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Night sweats
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Skin ulcer
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Arthritis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Groin pain
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    1 / 1 (100.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Clostridium difficile infection
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    Herpes zoster
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Skin infection
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Chronic sinusitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 4 (50.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    Sinusitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    1
    1
    Dehydration
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    1
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Oct 2015
    Key changes in the protocol amendment (Version 2): -Revised inclusion criterion #4 and deleted inclusion criterion #5; -Revised definition of a dose-limiting toxicity (DLT); -Added the IND number; -Changed the Medical Monitor; -Corrected the start of obinutuzumab regimen at Month 2, instead of at Month 1, during the maintenance treatment for patients with follicular lymphoma (FL). Patient enrollment commenced under Protocol Version 2.
    12 Feb 2016
    Key changes in the protocol amendment (Version 3): -Clarified patients to receive maintenance treatment; -Updated the number of study sites to 25; -Updated inclusion criteria; -Added uncontrolled GI conditions as part of the uncontrolled concomitant disease exclusion criteria; -Corrected concomitant therapy reporting period; -Clarified the modified Lugano criteria for designation of PET-CT−based PR; -Added an exploratory efficacy endpoint to analyze efficacy based on TP53 status; -Clarified that diarrhea (Grade ≥2), neutropenia (Grade ≥3), and thrombocytopenia (Grade ≥3 or Grade ≥2 if associated with hemorrhage or bleeding) are considered AESI; -Clarified criteria for patient replacement during the dose escalation phase; -Updated the dose-limiting toxicity criteria that Grade 3 diarrhea that responds to adequate therapy within 48 hours (instead of 72 hours) is not considered as a DLT; -Removed need for collection of human anti-human antibody samples; -Clarified that obinutuzumab PK samples are to be collected at Cycle 6 Day 1; -Clarified that Roche Clinical Repository sample collection is needed at Cycle 1 Day 5; -Clarified that deaths attributed to progression of lymphoma during follow-up is to be reported on the Study Completion/Early Discontinuation eCRF instead of being reported as an adverse event; -Added monthly pregnancy testing; -Included additional ECG collection timepoints (coupled to PK sampling) and instructions to enhance safety monitoring; -Clarified idasanutlin dose reduction steps; -Clarified management of other non-hematologic Grade 3 or 4 toxicities in patients who have had 0-2 prior dose reductions; -Updated dose and guidelines for loperamide usage; -Clarified prohibited therapy and exclusion criteria for anticoagulant treatment; -Updated background on idasanutlin for clarity; -Updated prohibited therapy list with OATP-1B1/3 transporter substrates as part of the prohibited therapy; -Harmonized obinutuzumab language among the obinutuzumab program.
    02 Mar 2017
    Key changes in the protocol amendment (Version 4): -Changed study design to add bridging cohort(s) in the dose escalation phase. Patients with DLBCL to receive idasanutlin in combination with rituximab after the MTD of idasanutlin is identified in combination with obinutuzumab. Updated background, rationale, study objectives, study design, eligibility criteria, and statistical plan; -Updated obinutuzumab exposure data; -Updated idasanutlin data based on the idasanutlin Investigator’s Brochure, Version 9 (November 2016, cutoff 13 September 2016); -Added idasanutlin as post-induction treatment in the expansion phase; exploratory efficacy endpoint added accordingly; -Clarified guidelines for the second and subsequent infusion of obinutuzumab; -Updated the classification of second malignancies; -Added Grade ≥2 Clostridium difficile infection as AESI; -Added an alternative regimen with obinutuzumab given alone at Cycle 1, followed by obinutuzumab in combination with idasanutlin from Cycles 2 to 6 (dose escalation phase for FL patients); -Modified the DLT definition to include any Grade 5 toxicities; -Updated the DLT criterion regarding thrombocytopenia; -Introduced a new DLT criterion regarding changes in liver enzyme; -Treatment Regimen and Expansion Phase (Part 2) sections; -Clarified exclusion criteria regarding the use of strong and moderate CYP3A inhibitors, strong and moderate CYP3A inducers, and CYP2C8 and OATP1B1/3 substrates; -Updated guidance on prohibited and cautionary therapies and their respective washout periods; -Clarified the dose reduction guidance; -Updated guidance regarding liver function test criteria -Updated guidance on the allowed time window for PK sample collection; -Defined interim analysis; -Clarified rescreening of patients.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    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.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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