A Study Evaluating the Safety, Efficacy and Pharmacokinet... | NCT02055820 | Trialant
NCT02055820
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Jun 11, 2020Actual
Enrollment
267Actual
Phase
Phase 1Phase 2
Conditions
Lymphoma, Non-Hodgkin
Interventions
Venetoclax
Cyclophosphamide
Obinutuzumab
Rituximab
Doxorubicin
Vincristine
Prednisone
Countries
United States
Australia
Austria
Canada
Czechia
France
Hungary
Italy
Netherlands
Spain
Protocol Section
Identification Module
NCT ID
NCT02055820
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GO27878
Secondary IDs
ID
Type
Description
Link
2013-003749-40
EudraCT Number
Brief Title
A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL
Official Title
A Phase Ib/II, Open-Label Study Evaluating the Safety, Efficacy and Pharmacokinetics of GDC-0199 (ABT-199) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
May 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 17, 2013Actual
Primary Completion Date
Jun 28, 2017Actual
Completion Date
Jun 28, 2019Actual
First Submitted Date
Feb 4, 2014
First Submission Date that Met QC Criteria
Feb 4, 2014
First Posted Date
Feb 5, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 26, 2018
Results First Submitted that Met QC Criteria
Dec 19, 2018
Results First Posted Date
Dec 20, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 26, 2020
Last Update Posted Date
Jun 11, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Name
Class
AbbVie
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a multicenter, open-label, dose-finding study of venetoclax administered orally in combination with rituximab (R) or obinutuzumab (G) and standard doses of cyclophosphamide, doxorubicin, vincristine and oral prednisone (CHOP) in participants with Non-Hodgkin's Lymphoma (NHL). The study consisted of 2 stages: a dose-finding Phase Ib stage and a Phase II expansion stage. In the Phase I portion of the study, participants were randomized to one of 2 treatment arms venetoclax in combination with R-CHOP (Arm A) and venetoclax in combination with G-CHOP (Arm B) and explored the doses of venetoclax in combination with R-CHOP and G-CHOP. The maximum tolerated dose (MTD) of venetoclax in combination with R-CHOP and G-CHOP was determined during the dose-finding stage. For the Phase II portion of the study, the venetoclax dose for venetoclax + R-CHOP was on a non-continuous dosing schedule as determined by the Phase Ib portion of the study based on safety and tolerability observed in participants treated in the dose escalation portion of the study. On 17 July 2016, Roche/Genentech as the sponsor of Study BO21005 (Goya study), a Phase III study that evaluated G CHOP versus R-CHOP in 1L DLBCL, informed through a press release that the primary endpoint of investigator-assessed PFS was not met. Given these results, Arm B (venetoclax + G-CHOP) was not expanded in Phase II in patients who are first-line with DLBCL.
Detailed Description
Not provided
Conditions Module
Conditions
Lymphoma, Non-Hodgkin
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
267Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Venetoclax + G-CHOP Arm
Experimental
Phase I: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle will consist of 21 days. Phase II: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle will consist of 21 days. For both phase I and II, participants with ongoing response without excessive toxicity may receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Drug: Venetoclax
Drug: Cyclophosphamide
Drug: Obinutuzumab
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone
Venetoclax + R-CHOP Arm
Experimental
Phase I: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle will consist of 21 days. Phase II: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle will consist of 21 days. For both phase I and II, participants with ongoing response without excessive toxicity may receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Drug: Venetoclax
Drug: Cyclophosphamide
Drug: Rituximab
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Venetoclax
Drug
Venetoclax 200 to 800 milligrams (mg) tablets will be administered orally once daily (QD) on Days 4-10 of Cycle 1 and Days 1-10 of Cycles 2-8 during Phase I and MTD will be administered according to the same schedule during Phase II.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Safety: Number of Participants With Dose-Limiting Toxicities (DLTs)
DLTs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0). Decrease in B cells, lymphopenia, and leukopenia caused by lymphopenia were not considered DLTs but instead were expected outcomes of study treatment. Any Grade >/= 3 adverse event, that was attributed to having a reasonable possibility of being related to the combined administration of venetoclax plus R-CHOP or G-CHOP, that could not be attributed by the investigator to an alternative, clearly identifiable cause such as tumor progression, concurrent illness or medical condition, or concomitant medication and that occurred during the DLT observation period (start of venetoclax treatment through end of Cycle 2) was considered a DLT for dose-escalation purposes. Grade 3 or 4 neutropenia or thrombocytopenia identified on Day 1 of Cycle 2 or 3, resulting in dose delay were considered DLTs.
Start of venetoclax administration (Cycle 1 Day 4 or 3 days after first CHOP dose) up to end of Cycle 2 (cycle length = 21 days)
Percentage of Previously Untreated DLBCL Participants With Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Scan Using the Modified Lugano Classification Assessed by Independent Review Committee (IRC)
CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake \
Baseline up to end of treatment (up to approximately 6 months)
Percentage of Participants With CR Defined by PET/CT Scan in Previously Untreated DLBCL Co-Expressing Both Bcl-2 and c-Myc Proteins (DE-DLBCL) Participants Assessed by IRC
CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake \
Secondary Outcomes
Measure
Description
Time Frame
Venetoclax Plasma PK: Area Under the Plasma Concentration-Time Curve (AUC)
AUC was calculated based on measurement of venetoclax concentration in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.
Data are reported as hour*micrograms per milliliter (hr*mcg/mL)
At least one bi-dimensionally measurable lymphoma lesion on CT scan defined as > 1.5 cm in its longest dimension, which is also FDG avid by screening PET scan.
Confirmed availability of archival or freshly biopsied tumor tissue prior to study enrollment
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Adequate hematologic function
For female participants of childbearing potential, agreement to use highly effective forms of contraception
Dose-Escalation Portion of the Study:
Participants must have histologically confirmed B-cell NHL, except MCL or SLL
Participants must have never received previous R-CHOP treatment
Any relapsed/refractory participants that are enrolled during the dose escalation should have received only a single previous treatment regimen
Expansion Portion of the Study:
Participants must have previously untreated CD20-positive DLBCL and IPI score must be 2-5
Exclusion Criteria:
General Exclusion Criteria:
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
Contraindication to receive any of the individual components of CHOP, rituximab or obinutuzumab
Prior anthracycline therapy
Participants with ongoing corticosteroid use >30 mg per day of prednisone or equivalent
CNS lymphoma or primary mediastinal DLBCL
Vaccination with live vaccines within 28 days prior to randomization
Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1
History of other malignancy that could affect compliance with the protocol or interpretation of results
Evidence of significant, uncontrolled concomitant disease
Significant cardiovascular disease or significant pulmonary disease
Left ventricular ejection fraction less than (<) 50% as defined by multiple-gated acquisition (MUGA)
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1 Day 1
Received the following agents within 7 days prior to the first dose of venetoclax: steroid therapy for anti-neoplastic intent; strong and moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers; grapefruit/grapefruit products, seville oranges or star fruit within 3 days prior to the first dose of venetoclax
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Recent major surgery
Women who are pregnant or lactating
Dose-Escalation Portion of the Study:
Participants with confirmed mantle cell lymphoma (MCL) or small lymphocytic lymphoma (SLL)
Expansion Portion of the Study:
Participants with transformed lymphoma (participants with discordant bone marrow involvement (i.e., low grade histology in bone marrow) may be considered after discussion with the Medical Monitor)
Zelenetz AD, Salles G, Mason KD, Casulo C, Le Gouill S, Sehn LH, Tilly H, Cartron G, Chamuleau MED, Goy A, Tam CS, Lugtenburg PJ, Petrich AM, Sinha A, Samineni D, Herter S, Ingalla E, Szafer-Glusman E, Klein C, Sampath D, Kornacker M, Mobasher M, Morschhauser F. Venetoclax plus R- or G-CHOP in non-Hodgkin lymphoma: results from the CAVALLI phase 1b trial. Blood. 2019 May 2;133(18):1964-1976. doi: 10.1182/blood-2018-11-880526. Epub 2019 Mar 8.
The data reported for participant flow is based on safety population, which includes all participants who received at least one dose of study medication.
Recruitment Details
At start the trial had a randomised-controlled component, until July 2016 once the arm B (Gazyva) got closed following the publication of results of another trial. Since July 2016, the trial was single-arm, not randomised anymore, and kept including patients in only 1 arm (Arm A, rituximab).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Venetoclax 200 mg +R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
FG001
Periods
Title
Milestones
Reasons Not Completed
Phase I: Dose-Finding
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0.05
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Oct 10, 2016
Jan 22, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Germany
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Venetoclax + G-CHOP Arm
Venetoclax + R-CHOP Arm
GDC-0199, ABT-199
Cyclophosphamide
Drug
Cyclophosphamide 750 milligrams per square meter (mg/m^2) administered intravenously (IV) on Day 1 of each 21-day cycle up to Cycle 6.
Venetoclax + G-CHOP Arm
Venetoclax + R-CHOP Arm
Obinutuzumab
Drug
Obinutuzumab will be administered by IV infusion as an absolute dose of 1000 mg on Days 1, 8, 15 of Cycle 1 and Day 1 of Cycles 2-8 (cycle length = 21 days).
Venetoclax + G-CHOP Arm
Rituximab
Drug
Rituximab 375 mg/m^2 dose will be administered IV on Day 1 of every 21-day cycle.
Venetoclax + R-CHOP Arm
MabThera/Rituxan
Doxorubicin
Drug
Doxorubicin 50 mg/m^2 administered IV on Day 1 of each 21-day cycle up to Cycle 6.
Venetoclax + G-CHOP Arm
Venetoclax + R-CHOP Arm
Vincristine
Drug
Vincristine 1.4 mg/m^2 (maximum 2 mg) administered IV on Day 1 of each 21-day cycle up to Cycle 6.
Venetoclax + G-CHOP Arm
Venetoclax + R-CHOP Arm
Prednisone
Drug
Prednisone 100 mg per day orally on Days 1-5 of each 21-day cycle up to Cycle 6.
Venetoclax + G-CHOP Arm
Venetoclax + R-CHOP Arm
Baseline up to end of treatment (up to approximately 6 months)
Venetoclax Plasma PK: Time to Maximum Observed Plasma Concentration (Tmax)
Tmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.
Venetoclax Plasma PK: Maximum Observed Plasma Concentration (Cmax)
Cmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.
Venetoclax Plasma PK: Minimum Plasma Concentration (Cmin) Within the Dosing Interval
Cmin was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.
AUC was determined based on measurement of Predisone concentrations in plasma over time.
Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
Prednisone Plasma PK: Tmax
Tmax was determined based on measurement of Predisone concentrations in plasma over time.
Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
Prednisone Plasma PK: Cmax
Cmax was determined based on measurement of Predisone concentrations in plasma over time.
Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
Rituximab PK: Cmax
Cmax was determined using the post-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1.
End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Rituximab PK: Cmin Within the Dosing Interval
Cmin was determined using the pre-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose on Day 1 of Cycle 2.
Pre-dose on Cycle 2 Day 1 (cycle length = 21 days)
Obinutuzumab PK: Cmax
Cmax was determined using the post-dose obinutuzumab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1.
End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Cyclophosphamide PK: Cmax
Cmax was determined using the post-dose Cyclophosphamide plasma concentrations on Cycle 1 Day 1.
End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Doxorubicin PK: Cmax
Cmax was determined using the post-dose Doxorubicin plasma concentrations.
End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Vincristine PK: Cmax
Cmax was determined using the post-dose Vincristine plasma concentrations.
End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Percentage of Participants With Objective Response Defined as Partial Response (PR) or Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Using the Modified Lugano Classification Assessed by IRC
Objective Response defined as PR (partial response) or CR (complete response) at end of treatment.
CR: Lymph nodes and extra-lymphatic sites with score 1, 2 or 3 on a 5-point scale (with a higher score being a worse outcome). No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.
PR: Lymph nodes and extralymphatic sites with score of 4 or 5 on the 5-point scale with reduced uptake compared with baseline and residual mass(es) of any size. CT-based response criteria for PR must also be met. No new lesions. In bone marrow residual uptake could be higher than in normal marrow but must be reduced compared with baseline; persistent focal changes in the marrow to be considered for further evaluation with magnetic resonance imaging (MRI) or biopsy or an interval scan. OR=PR+CR
Baseline to end of treatment (up to approximately 6 months)
Percentage of Participants Who Are Alive and Without Disease Progression at Month 12
Progressive disease (PD) was determined using the modified Lugano classification criteria. For PET-CT-based PD: Score 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with an increase in intensity of uptake from baseline in target nodes and nodal lesions, new FDG-uptake foci of extranodal lesions consistent with lymphoma at interim or end-of-treatment assessment, no non-measured lesions, new FDG-uptake foci consistent with lymphoma, new or recurrent FDG-uptake foci in bone marrow. For CT-based PD: >/= 50% decrease in SPD of up to 6 target measureable nodes and extranodal sites; non-measured lesion should be absent/normal, have regressed, but not increased; no new lesions.
Month 12
Percentage of Participants With CR Defined by Computed Tomography (CT) Scan Using the Modified Lugano Classification
CR was defined as follows according to modified Lugano classification for CT-based response: Target nodes/nodal masses must have regressed to \
Baseline up to end of treatment (approx. 6 months)
Safety: Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Baseline up to approximately 36 months
Safety: Percentage of Participants Maintaining Relative Dose Intensity of CHOP Chemotherapy
Maintenance of relative dose intensity was defined as a dose intensity of >/= 90%.
Baseline up to Cycle 6 (cycle length = 21 days)
Relative Dose Intensity of Venetoclax
Dose intensity was categorized as < 80%, 80% to < 85%, 85% to < 90%, or >/= 90%.
Baseline up to Cycle 6 (cycle length = 21 days)
Los Angeles
California
90095
United States
Central Coast Medical Oncology
Santa Maria
California
93454
United States
The West Clinici
St Louis
Missouri
63129
United States
Hackensack University Medical Center; WFAN - Imus Pediatric Center
Hackensack
New Jersey
07601
United States
San Juan Oncology Associates
Farmington
New Mexico
87401
United States
Memorial Sloan-Kettering Cancer Center
New York
New York
10065
United States
Uni of Rochester Medical Center; Wilmot Cancer Center, Pharmacy Department
Rochester
New York
14642
United States
Tennessee Oncology
Nashville
Tennessee
37203
United States
Concord Repatriation General Hospital
Concord
New South Wales
2139
Australia
Princess Alexandra Hospital
Woolloongabba
Queensland
4102
Australia
Peter MacCallum Cancer Centre-East Melbourne
Melbourne
Victoria
3000
Australia
Royal Melbourne Hospital
Parkville
Victoria
3050
Australia
LKH - Universitätsklinikum der PMU Salzburg
Salzburg
5020
Austria
Medizinische Universität Wien
Vienna
1090
Austria
Cross Cancer Institute
Edmonton
Alberta
T6G 1Z2
Canada
BC Cancer Agency, CSI
Kelowna
British Columbia
V1Y 5L3
Canada
BC Cancer Agency Vancouver Centre - PARENT; BC Cancer Agency
ICO l´Hospitalet - Hospital Duran i Reynals; Hematology
Barcelona
08907
Spain
Hospital Universitario La Paz
Madrid
280146
Spain
Hospital Universitario Ramon y Cajal
Madrid
28034
Spain
Hospital Universitario de Salamanca
Salamanca
37007
Spain
Derived
Samineni D, Huang W, Gibiansky L, Ding H, Zhang R, Li C, Sinha A, Rajwanshi R, Humphrey K, Bazeos A, Salem AH, Miles D. Population Pharmacokinetics and Exposure-Response Analyses for Venetoclax in Combination with R-CHOP in Relapsed/Refractory and Previously Untreated Patients with Diffuse Large B Cell Lymphoma. Adv Ther. 2022 Jan;39(1):598-618. doi: 10.1007/s12325-021-01919-z. Epub 2021 Nov 25.
Morschhauser F, Feugier P, Flinn IW, Gasiorowski R, Greil R, Illes A, Johnson NA, Larouche JF, Lugtenburg PJ, Patti C, Salles GA, Trneny M, de Vos S, Mir F, Samineni D, Kim SY, Jiang Y, Punnoose E, Sinha A, Clark E, Spielewoy N, Humphrey K, Bazeos A, Zelenetz AD. A phase 2 study of venetoclax plus R-CHOP as first-line treatment for patients with diffuse large B-cell lymphoma. Blood. 2021 Feb 4;137(5):600-609. doi: 10.1182/blood.2020006578.
Venetoclax 400 mg +R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
FG002
Venetoclax 600 mg +R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
FG003
Venetoclax 800 mg +R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
FG004
Venetoclax 800 mg +R-CHOP Phase II
Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
FG005
Venetoclax 200 mg +G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
FG006
Venetoclax 400 mg +G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
FG007
Venetoclax 600 mg +G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
FG008
Venetoclax 800 mg + G-CHOP A
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. In this arm venetoclax was administered as follows: Cycle 1 Days 4-10; Cycles 2-8 Days 1-10, Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
FG009
Venetoclax 800 mg +G-CHOP B
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. In this arm venetoclax was administered as follows: Cycle 1 Days 4-8; Cycles 2-8 Days 1-5. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
FG0007 subjects
FG0013 subjects
FG0028 subjects
FG0036 subjects
FG0040 subjects
FG0057 subjects
FG0067 subjects
FG0076 subjects
FG0086 subjects
FG0096 subjects
COMPLETED
FG0006 subjects
FG0013 subjects
FG0027 subjects
FG0033 subjects
FG0040 subjects
FG0055 subjects
FG0065 subjects
FG0076 subjects
FG0086 subjects
FG0096 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0033 subjects
FG0040 subjects
FG0052 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Phase II: Expansion
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004208 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Venetoclax 200 mg +R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
BG001
Venetoclax 400 mg +R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
BG002
Venetoclax 600 mg +R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
BG003
Venetoclax 800 mg +R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
BG004
Venetoclax 800 mg +R-CHOP Phase II
Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
BG005
Venetoclax 200 mg +G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
BG006
Venetoclax 400 mg +G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
BG007
Venetoclax 600 mg +G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
BG008
Venetoclax 800 mg + G-CHOP A
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. In this arm venetoclax was administered as follows: Cycle 1 Days 4-10; Cycles 2-8 Days 1-10, Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
BG009
Venetoclax 800 mg +G-CHOP B
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. In this arm venetoclax was administered as follows: Cycle 1 Days 4-8; Cycles 2-8 Days 1-5. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0007
BG0013
BG0028
BG0036
BG004208
BG0057
BG0067
BG0076
BG0086
BG0096
BG010264
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00067.0± 9.2
BG00161.0± 13.1
BG00257.0± 9.5
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Safety: Number of Participants With Dose-Limiting Toxicities (DLTs)
DLTs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0). Decrease in B cells, lymphopenia, and leukopenia caused by lymphopenia were not considered DLTs but instead were expected outcomes of study treatment. Any Grade >/= 3 adverse event, that was attributed to having a reasonable possibility of being related to the combined administration of venetoclax plus R-CHOP or G-CHOP, that could not be attributed by the investigator to an alternative, clearly identifiable cause such as tumor progression, concurrent illness or medical condition, or concomitant medication and that occurred during the DLT observation period (start of venetoclax treatment through end of Cycle 2) was considered a DLT for dose-escalation purposes. Grade 3 or 4 neutropenia or thrombocytopenia identified on Day 1 of Cycle 2 or 3, resulting in dose delay were considered DLTs.
Safety population: All participants who enrolled in the study and received any amount of venetoclax or R-CHOP/G-CHOP were included in the safety population for safety analyses. Here, participants in the Dose Finding phase were analyzed.
Posted
Number
Participants
Start of venetoclax administration (Cycle 1 Day 4 or 3 days after first CHOP dose) up to end of Cycle 2 (cycle length = 21 days)
ID
Title
Description
OG000
Venetoclax 200 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG001
Venetoclax 400 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG002
Venetoclax 600 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG003
Venetoclax 800mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG004
Venetoclax 200mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Counts
Participants
OG0007
OG0013
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0021
OG003
Primary
Percentage of Previously Untreated DLBCL Participants With Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Scan Using the Modified Lugano Classification Assessed by Independent Review Committee (IRC)
CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake \
Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline up to end of treatment (up to approximately 6 months)
ID
Title
Description
OG000
Venetoclax + R-CHOP 800 mg Phase II
Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Primary
Percentage of Participants With CR Defined by PET/CT Scan in Previously Untreated DLBCL Co-Expressing Both Bcl-2 and c-Myc Proteins (DE-DLBCL) Participants Assessed by IRC
CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake \
Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for subgroup of the ITT, DE Participants.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline up to end of treatment (up to approximately 6 months)
ID
Title
Description
OG000
Venetoclax + R-CHOP 800 mg Phase II
Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Counts
Secondary
Venetoclax Plasma PK: Area Under the Plasma Concentration-Time Curve (AUC)
AUC was calculated based on measurement of venetoclax concentration in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.
Data are reported as hour*micrograms per milliliter (hr*mcg/mL)
PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Reporting according to study drug received. One participant mistakenly received only 100 mg instead of the planned 200 mg dose and was reported in a separate arm for PK outcome measures.
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG001
Venetoclax 200 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Secondary
Venetoclax Plasma PK: Time to Maximum Observed Plasma Concentration (Tmax)
Tmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.
PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Reporting according to study drug received. One participant mistakenly received only 100 mg instead of the planned 200 mg dose and was reported in a separate arm for PK outcome measures.
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG001
Venetoclax 200 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Secondary
Venetoclax Plasma PK: Maximum Observed Plasma Concentration (Cmax)
Cmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.
Data are reported as micrograms per milliliter
PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Reporting according to study drug received. One participant mistakenly received only 100 mg instead of the planned 200 mg dose and was reported in a separate arm for PK outcome measures.
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG001
Venetoclax 200 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Secondary
Venetoclax Plasma PK: Minimum Plasma Concentration (Cmin) Within the Dosing Interval
Cmin was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.
PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Reporting according to study drug received. One participant mistakenly received only 100 mg instead of the planned 200 mg dose and was reported in a separate arm for PK outcome measures.
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG001
Venetoclax 200 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Secondary
Prednisone Plasma PK: AUC
AUC was determined based on measurement of Predisone concentrations in plasma over time.
PK evaluable population: All participants who received study drug and provided at least one post-treatment PK sample. A similar dose strength of prednisone (100 mg) was administered across the treatment arms/venetoclax dose groups. Hence, the data are presented as an overall summary in Cycles 1 and 2.
Posted
Mean
Standard Deviation
hr*mcg/mL
Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
ID
Title
Description
OG000
Venetoclax PK Popluation
All participants in the study.
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Counts
Participants
OG000
Secondary
Prednisone Plasma PK: Tmax
Tmax was determined based on measurement of Predisone concentrations in plasma over time.
PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. A similar dose strength of prednisone (100 mg) was administered across the treatment arms/venetoclax dose groups. Hence, the data are presented as an overall summary in Cycles 1 and 2.
Posted
Mean
Standard Deviation
Hour
Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
ID
Title
Description
OG000
Venetoclax PK Popluation
All participants in the study.
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Counts
Participants
Secondary
Prednisone Plasma PK: Cmax
Cmax was determined based on measurement of Predisone concentrations in plasma over time.
PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. A similar dose strength of prednisone (100 mg) was administered across the treatment arms/venetoclax dose groups. Hence, the data are presented as an overall summary in Cycles 1 and 2.
Posted
Mean
Standard Deviation
Ng/ML
Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
ID
Title
Description
OG000
Venetoclax PK Popluation
All participants in the study.
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Counts
Participants
Secondary
Rituximab PK: Cmax
Cmax was determined using the post-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1.
PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. The Cmax of rituximab is presented at the 800 mg Venetoclax dose group. Hence, the data is not presented by the treatment arms/Venetoclax dose groups.
Posted
Mean
Standard Deviation
mcg/mL
End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
ID
Title
Description
OG000
Venetoclax 800 mg
All participants in the study, who received 800 mg venetoclax.
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Counts
Participants
OG000
Secondary
Rituximab PK: Cmin Within the Dosing Interval
Cmin was determined using the pre-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose on Day 1 of Cycle 2.
PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. The Cmin of rituximab is presented at the 800 mg Venetoclax dose group. Hence, the data is not presented by the treatment arms/Venetoclax dose groups.
Posted
Mean
Standard Deviation
mcg/mL
Pre-dose on Cycle 2 Day 1 (cycle length = 21 days)
ID
Title
Description
OG000
Venetoclax 800 mg
All participants in the study, who received 800 mg venetoclax.
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Counts
Participants
OG000
Secondary
Obinutuzumab PK: Cmax
Cmax was determined using the post-dose obinutuzumab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1.
PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. The Cmax of obinutuzumab is presented at the 800 mg Venetoclax dose group. Hence, the data is not presented by the treatment arms/Venetoclax dose groups.
Posted
Mean
Standard Deviation
mcg/mL
End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
ID
Title
Description
OG000
Venetoclax 800 mg
All participants in the study, who received 800 mg venetoclax.
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Counts
Participants
Secondary
Cyclophosphamide PK: Cmax
Cmax was determined using the post-dose Cyclophosphamide plasma concentrations on Cycle 1 Day 1.
PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Given a single dose strength of Cyclophosphamide was administered across the different Venetoclax dose groups and treatment arms, hence the data are presented as an overall summary.
Posted
Mean
Standard Deviation
mcg/mL
End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
ID
Title
Description
OG000
Venetoclax PK Popluation
All participants in the study.
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Counts
Participants
OG000
Secondary
Doxorubicin PK: Cmax
Cmax was determined using the post-dose Doxorubicin plasma concentrations.
PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Given a single dose strength of Doxorubicin was administered across the different Venetoclax dose groups and treatment arms, hence the data are presented as an overall summary.
Posted
Mean
Standard Deviation
mcg/mL
End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
ID
Title
Description
OG000
Venetoclax PK Popluation
All participants in the study.
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Counts
Participants
OG000
Secondary
Vincristine PK: Cmax
Cmax was determined using the post-dose Vincristine plasma concentrations.
PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Given a single dose strength of Vincristine was administered across the different Venetoclax dose groups and treatment arms, hence the data are presented as an overall summary.
Posted
Mean
Standard Deviation
mcg/mL
End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
ID
Title
Description
OG000
Venetoclax PK Popluation
All participants in the study.
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With Objective Response Defined as Partial Response (PR) or Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Using the Modified Lugano Classification Assessed by IRC
Objective Response defined as PR (partial response) or CR (complete response) at end of treatment.
CR: Lymph nodes and extra-lymphatic sites with score 1, 2 or 3 on a 5-point scale (with a higher score being a worse outcome). No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.
PR: Lymph nodes and extralymphatic sites with score of 4 or 5 on the 5-point scale with reduced uptake compared with baseline and residual mass(es) of any size. CT-based response criteria for PR must also be met. No new lesions. In bone marrow residual uptake could be higher than in normal marrow but must be reduced compared with baseline; persistent focal changes in the marrow to be considered for further evaluation with magnetic resonance imaging (MRI) or biopsy or an interval scan. OR=PR+CR
Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available.
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline to end of treatment (up to approximately 6 months)
ID
Title
Description
OG000
Venetoclax + R-CHOP 800 mg Phase II
Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Secondary
Percentage of Participants Who Are Alive and Without Disease Progression at Month 12
Progressive disease (PD) was determined using the modified Lugano classification criteria. For PET-CT-based PD: Score 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with an increase in intensity of uptake from baseline in target nodes and nodal lesions, new FDG-uptake foci of extranodal lesions consistent with lymphoma at interim or end-of-treatment assessment, no non-measured lesions, new FDG-uptake foci consistent with lymphoma, new or recurrent FDG-uptake foci in bone marrow. For CT-based PD: >/= 50% decrease in SPD of up to 6 target measureable nodes and extranodal sites; non-measured lesion should be absent/normal, have regressed, but not increased; no new lesions.
Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available.
Posted
Number
95% Confidence Interval
Percentage of Participants
Month 12
ID
Title
Description
OG000
Venetoclax 200 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG001
Venetoclax 400 mg + R-CHOP
Secondary
Percentage of Participants With CR Defined by Computed Tomography (CT) Scan Using the Modified Lugano Classification
CR was defined as follows according to modified Lugano classification for CT-based response: Target nodes/nodal masses must have regressed to \
Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available.
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline up to end of treatment (approx. 6 months)
ID
Title
Description
OG000
Venetoclax + R-CHOP 800 mg Phase II
Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Counts
Participants
Secondary
Safety: Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Safety population: All patients who enrolled in the study and received any amount of venetoclax or R-CHOP/G-CHOP were included in the safety population for safety analyses
Posted
Number
Percentage of Participants
Baseline up to approximately 36 months
ID
Title
Description
OG000
Venetoclax 200 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG001
Venetoclax 400 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Secondary
Safety: Percentage of Participants Maintaining Relative Dose Intensity of CHOP Chemotherapy
Maintenance of relative dose intensity was defined as a dose intensity of >/= 90%.
Safety population: All patients who enrolled in the study and received any amount of venetoclax or R-CHOP/G-CHOP were included in the safety population for safety analyses. Overall R-CHOP and G-CHOP arms were analyzed for this outcome measure.
Posted
Number
Percentage of participants
Baseline up to Cycle 6 (cycle length = 21 days)
ID
Title
Description
OG000
Venetoclax + R-CHOP Arm
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days.
Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days.
Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG001
Venetoclax 600mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Secondary
Relative Dose Intensity of Venetoclax
Dose intensity was categorized as < 80%, 80% to < 85%, 85% to < 90%, or >/= 90%.
Safety population: All patients who enrolled in the study and received any amount of venetoclax or R-CHOP/G-CHOP were included in the safety population for safety analyses
Posted
Number
Percentage of Partcipants
Baseline up to Cycle 6 (cycle length = 21 days)
ID
Title
Description
OG000
Venetoclax 200 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG001
Venetoclax 400 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG002
Venetoclax 600 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Time Frame
Baseline up to approximately 67 months
Description
Safety population: All participants, who were enrolled in the study and received any amount of venetoclax or R-CHOP/G-CHOP were included in the safety population.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Venetoclax 200 mg +R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
1
7
5
7
7
7
EG001
Venetoclax 400 mg +R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
0
3
2
3
3
3
EG002
Venetoclax 600 mg +R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
1
8
4
8
8
8
EG003
Venetoclax 800 mg +R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
4
6
3
6
6
6
EG004
Venetoclax 800 mg +R-CHOP Phase II
Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
33
208
116
208
204
208
EG005
Venetoclax 200 mg +G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
1
7
5
7
7
7
EG006
Venetoclax 400 mg +G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
1
7
4
7
7
7
EG007
Venetoclax 600 mg +G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
0
6
3
6
6
6
EG008
Venetoclax 800 mg + G-CHOP A
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. In this arm venetoclax was administered as follows: Cycle 1 Days 4-10; Cycles 2-8 Days 1-10, Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
0
6
5
6
6
6
EG009
Venetoclax 800 mg +G-CHOP B
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. In this arm venetoclax was administered as follows: Cycle 1 Days 4-8; Cycles 2-8 Days 1-5. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
0
6
5
6
6
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
AGRANULOCYTOSIS
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG004
ANAEMIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected8 at risk
EG003
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0005 events3 affected7 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected8 at risk
EG003
HAEMOLYTIC ANAEMIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ACUTE CORONARY SYNDROME
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ATRIOVENTRICULAR BLOCK
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CARDIAC ARREST
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CARDIAC FAILURE
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CARDIAC FAILURE CONGESTIVE
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CARDIOGENIC SHOCK
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CARDIOMYOPATHY
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected8 at risk
EG003
LEFT VENTRICULAR FAILURE
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
MYOCARDIAL ISCHAEMIA
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
SINUS TACHYCARDIA
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
SUPRAVENTRICULAR TACHYCARDIA
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
OPTIC NEUROPATHY
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DIVERTICULAR PERFORATION
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DUODENAL STENOSIS
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ENTEROCOLITIS
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
GASTRIC DILATATION
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
GASTRIC PERFORATION
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
GASTRIC STENOSIS
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
GASTRIC ULCER
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
GASTRIC ULCER PERFORATION
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
GASTROINTESTINAL PAIN
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HAEMATEMESIS
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ILEAL PERFORATION
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ILEUS
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
OBSTRUCTION GASTRIC
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
OESOPHAGEAL STENOSIS
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PANCREATITIS
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
RECTAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
SMALL INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
UPPER GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ASTHENIA
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
FATIGUE
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
INFLAMMATION
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PYREXIA
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
SUDDEN CARDIAC DEATH
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
BILE DUCT STONE
Hepatobiliary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CHOLECYSTITIS
Hepatobiliary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CHOLECYSTITIS ACUTE
Hepatobiliary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DRUG-INDUCED LIVER INJURY
Hepatobiliary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HYPOGAMMAGLOBULINAEMIA
Immune system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ACUTE SINUSITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ATYPICAL PNEUMONIA
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
BACTERIAL SEPSIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CLOSTRIDIUM COLITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CLOSTRIDIUM DIFFICILE INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DEVICE RELATED INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DIVERTICULITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
EMPYEMA
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ESCHERICHIA PYELONEPHRITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ESCHERICHIA URINARY TRACT INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
GASTROENTERITIS NOROVIRUS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HERPES SIMPLEX
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
LOWER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
LUNG INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
MENINGITIS VIRAL
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
OOPHORITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PNEUMOCYSTIS JIROVECII INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PNEUMOCYSTIS JIROVECII PNEUMONIA
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PSEUDOMONAL SEPSIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
RECTAL ABSCESS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
RHINOVIRUS INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
SEPSIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
SIALOADENITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
SKIN INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
STAPHYLOCOCCAL SEPSIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
URINARY TRACT INFECTION PSEUDOMONAL
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
VASCULAR DEVICE INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
INFUSION RELATED REACTION
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
LIGAMENT RUPTURE
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
POST LUMBAR PUNCTURE SYNDROME
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
SPINAL FRACTURE
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
TOXICITY TO VARIOUS AGENTS
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
BLOOD POTASSIUM INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
C-REACTIVE PROTEIN INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DIABETES MELLITUS INADEQUATE CONTROL
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
TUMOUR LYSIS SYNDROME
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
JOINT SWELLING
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
SPONDYLOLISTHESIS
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ACUTE MYELOID LEUKAEMIA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ADENOLYMPHOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
GLIOBLASTOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HISTIOCYTOSIS
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
LUNG NEOPLASM MALIGNANT
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
MYELODYSPLASTIC SYNDROME
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
CAROTID SINUS SYNDROME
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
EPILEPSY
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HYPOGLOSSAL NERVE PARESIS
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
POLYNEUROPATHY
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PRESYNCOPE
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
TRANSIENT ISCHAEMIC ATTACK
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PSYCHOTIC DISORDER
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HAEMOPTYSIS
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
INTERSTITIAL LUNG DISEASE
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
ORGANISING PNEUMONIA
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PNEUMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
EMBOLISM
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0009 events4 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG0032 events2 affected6 at risk
EG004117 events73 affected208 at risk
EG0051 events1 affected7 at risk
EG0061 events1 affected7 at risk
EG0074 events1 affected6 at risk
EG0088 events5 affected6 at risk
EG0095 events4 affected6 at risk
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
HAEMOLYTIC ANAEMIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0009 events4 affected7 at risk
EG0018 events2 affected3 at risk
EG00218 events6 affected8 at risk
EG003
PANCYTOPENIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0007 events4 affected7 at risk
EG0012 events1 affected3 at risk
EG0025 events3 affected8 at risk
EG003
ANGINA PECTORIS
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
CARDIAC FAILURE
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PALPITATIONS
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
ICHTHYOSIS
Congenital, familial and genetic disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
EAR PAIN
Ear and labyrinth disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
TINNITUS
Ear and labyrinth disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DRY EYE
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
EYE PAIN
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
LACRIMATION INCREASED
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PHOTOPHOBIA
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
VITREOUS FLOATERS
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected8 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0012 events2 affected3 at risk
EG0023 events3 affected8 at risk
EG003
DENTAL CARIES
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DENTAL CYST
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG00010 events3 affected7 at risk
EG0014 events2 affected3 at risk
EG0022 events2 affected8 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
GASTRIC ULCER
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
GASTROINTESTINAL DISORDER
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
GINGIVAL PAIN
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
MOUTH ULCERATION
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected8 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0003 events3 affected7 at risk
EG0014 events2 affected3 at risk
EG0021 events1 affected8 at risk
EG003
ORAL PAIN
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PROCTALGIA
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected8 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected8 at risk
EG003
ASTHENIA
General disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0012 events1 affected3 at risk
EG0022 events2 affected8 at risk
EG003
CHEST PAIN
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CHILLS
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
FATIGUE
General disorders
MedDRA version 22.0
Systematic Assessment
EG0005 events5 affected7 at risk
EG0010 events0 affected3 at risk
EG0023 events3 affected8 at risk
EG003
FEELING ABNORMAL
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
GAIT DISTURBANCE
General disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
INFUSION SITE EXTRAVASATION
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
MALAISE
General disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
MUCOSAL INFLAMMATION
General disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected8 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
OEDEMA
General disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected8 at risk
EG003
PAIN
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PYREXIA
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
UNEVALUABLE EVENT
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CHOLELITHIASIS
Hepatobiliary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HYPERBILIRUBINAEMIA
Hepatobiliary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HYPERSENSITIVITY
Immune system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HYPOGAMMAGLOBULINAEMIA
Immune system disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ANORECTAL INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected8 at risk
EG003
CAMPYLOBACTER GASTROENTERITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
CANDIDA INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CELLULITIS ORBITAL
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CLOSTRIDIUM DIFFICILE COLITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CLOSTRIDIUM DIFFICILE INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CONJUNCTIVITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DEVICE RELATED INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ENTEROVIRUS INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ERYSIPELAS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
FURUNCLE
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HERPES SIMPLEX
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
LUNG INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ORAL FUNGAL INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PNEUMOCYSTIS JIROVECII PNEUMONIA
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PSEUDOMONAL BACTERAEMIA
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
RHINITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
SEPSIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
SINUSITIS BACTERIAL
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
SKIN INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
STAPHYLOCOCCAL INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
TOOTH ABSCESS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
VASCULAR DEVICE INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
VULVOVAGINAL CANDIDIASIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HAND FRACTURE
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
INFUSION RELATED REACTION
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0012 events2 affected3 at risk
EG0021 events1 affected8 at risk
EG003
MUSCLE STRAIN
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
PROCEDURAL PAIN
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
THERMAL BURN
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
TRACHEAL OBSTRUCTION
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
BLOOD MAGNESIUM DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
BLOOD POTASSIUM INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
COMPUTERISED TOMOGRAM THORAX ABNORMAL
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
EJECTION FRACTION DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
URINE OUTPUT DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0003 events2 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
WHITE BLOOD CELL COUNT DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected8 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
FLUID RETENTION
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
GOUT
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HYPERPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HYPERURICAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HYPOCHLORAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0004 events3 affected7 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected8 at risk
EG003
HYPOMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0006 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HYPOPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
TUMOUR LYSIS SYNDROME
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0004 events2 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected8 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PAIN IN JAW
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
SQUAMOUS CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
SQUAMOUS CELL CARCINOMA OF SKIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
AGEUSIA
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
CAROTID SINUS SYNDROME
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
COGNITIVE DISORDER
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DISTURBANCE IN ATTENTION
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected8 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0023 events3 affected8 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
LETHARGY
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
MEMORY IMPAIRMENT
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
NEUROPATHY PERIPHERAL
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0012 events1 affected3 at risk
EG0023 events3 affected8 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PERIPHERAL MOTOR NEUROPATHY
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PERIPHERAL SENSORY NEUROPATHY
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0003 events3 affected7 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected8 at risk
EG003
POST HERPETIC NEURALGIA
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PRESYNCOPE
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0023 events2 affected8 at risk
EG003
MOOD SWINGS
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
BLADDER HYPERTROPHY
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DYSURIA
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
NOCTURIA
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
POLLAKIURIA
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
RENAL FAILURE
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
URINARY INCONTINENCE
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
URINARY TRACT PAIN
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
BREAST PAIN
Reproductive system and breast disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
TESTICULAR PAIN
Reproductive system and breast disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
VAGINAL DISCHARGE
Reproductive system and breast disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
VULVOVAGINAL DRYNESS
Reproductive system and breast disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected3 at risk
EG0024 events3 affected8 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0003 events2 affected7 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DYSPNOEA EXERTIONAL
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected8 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HICCUPS
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PLEURITIC PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
SINUS PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
VOCAL CORD DYSFUNCTION
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
WHEEZING
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected8 at risk
EG003
ECCHYMOSIS
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
NAIL DISCOLOURATION
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
NIGHT SWEATS
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PIGMENTATION DISORDER
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected8 at risk
EG003
PURPURA
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
SKIN HYPERPIGMENTATION
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
THROMBOPHLEBITIS
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG006
Venetoclax 600mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG007
Venetoclax 800 mg + G-CHOP A
Venetoclax + G-CHOP 800 mg A Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. In this arm venetoclax was delivered in Cycle 1 on Days 4-10 and Cycles 2-8 on Days 1-10. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG008
Venetoclax 800 mg + G-CHOP B
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. In this arm ventoclax was delivered in Cycle 1 on Days 4-8 and Cycles 2-8 on Days 1-5. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
6
OG0047
OG0057
OG0066
OG0076
OG0086
0
OG0042
OG0051
OG0061
OG0070
OG0080
Counts
Participants
OG000211
Title
Denominators
Categories
Title
Measurements
OG00068.2(61.50 to 74.47)
Participants
OG00081
Title
Denominators
Categories
Title
Measurements
OG00066.7(55.32 to 76.76)
OG002
Venetoclax 400 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG003
Venetoclax 600 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG004
Venetoclax + R-CHOP 800 mg
Phase I and II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG005
Venetoclax 200mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG006
Venetoclax 400mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG007
Venetoclax 600mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG008
Venetoclax + G-CHOP 800mg
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Counts
Participants
OG0001
OG0016
OG0024
OG0038
OG004124
OG0057
OG0067
OG0076
OG00810
Title
Denominators
Categories
Title
Measurements
OG000.66± NAN/A as there is only one participant in this cohort
OG0012.51± .97
OG0023.87± 2.41
OG0033.70± 1.59
OG0044.51± 2.32
OG0052.55± 1.13
OG0064.33± 1.31
OG0075.13± 2.41
OG0086.20± 1.71
OG002
Venetoclax 400 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG003
Venetoclax 600 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG004
Venetoclax 800mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG005
Venetoclax 200mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG006
Venetoclax 400mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG007
Venetoclax 600mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG008
Venetoclax + G-CHOP 800 mg
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Counts
Participants
OG0001
OG0016
OG0024
OG0038
OG004124
OG0057
OG0067
OG0076
OG00810
Title
Denominators
Categories
Title
Measurements
OG0004.0± NAN/A as there is only one participant in this cohort
OG0014.59± 1.08
OG0026.50± 1.91
OG0035.52± 2.07
OG0045.53± 1.55
OG0055.72± 1.42
OG0066.56± 1.51
OG0075.30± 2.38
OG0085.79± 1.47
OG002
Venetoclax 400 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG003
Venetoclax 600 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG004
Venetoclax 800mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG005
Venetoclax 200mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG006
Venetoclax 400mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG007
Venetoclax 600mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG008
Venetoclax + G-CHOP 800 mg
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Counts
Participants
OG0001
OG0016
OG0024
OG0038
OG004124
OG0057
OG0067
OG0076
OG00810
Title
Denominators
Categories
Title
Measurements
OG000.09± NAN/A as there is only one participant in this cohort
OG001.58± .32
OG002.92± .64
OG003.85± .33
OG0041.15± .48
OG005.52± .21
OG0061.26± .30
OG0071.00± .58
OG0081.54± .37
OG002
Venetoclax 400 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG003
Venetoclax 600 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG004
Venetoclax 800mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG005
Venetoclax 200mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG006
Venetoclax 400mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG007
Venetoclax 600mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG008
Venetoclax + G-CHOP 800 mg
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Counts
Participants
OG0001
OG0013
OG0022
OG0034
OG004126
OG0057
OG0065
OG0075
OG0086
Title
Denominators
Categories
Title
Measurements
OG0000.0714± 0.00
OG0010.522± 0.441
OG0020.253± 0.247
OG0030.387± 0.141
OG0040.640± 0.451
OG0050.134± 0.107
OG0060.395± 0.381
OG0070.612± 0.535
OG0080.628± 0.395
54
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG00052
Title
Measurements
OG000195± 72.8
Cycle 2, Day 1
ParticipantsOG00054
Title
Measurements
OG000184± 81.2
OG000
54
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG00052
Title
Measurements
OG0002.19± 1.61
Cycle 2, Day 1
ParticipantsOG00054
Title
Measurements
OG0003.80± 2.52
OG000
54
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG00052
Title
Measurements
OG00049.9± 28.7
Cycle 2, Day 1
ParticipantsOG00054
Title
Measurements
OG00043.2± 17.6
7
Title
Denominators
Categories
Title
Measurements
OG000173± 39.4
8
Title
Denominators
Categories
Title
Measurements
OG00026.1± 13
OG000
10
Title
Denominators
Categories
Title
Measurements
OG000326± 76
36
Title
Denominators
Categories
Title
Measurements
OG00032.1± 7.51
24
Title
Denominators
Categories
Title
Measurements
OG0001260± 911
28
Title
Denominators
Categories
Title
Measurements
OG00054.0± 44.6
Units
Counts
Participants
OG000211
Title
Denominators
Categories
Title
Measurements
OG00081.5(75.61 to 86.51)
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG002
Venetoclax 600 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG003
Venetoclax 800mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG004
Venetoclax + R-CHOP 800 mg Phase II
Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG005
Venetoclax 200mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG006
Venetoclax 400mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG007
Venetoclax 600mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG008
Venetoclax 800 mg + G-CHOP A
Venetoclax + G-CHOP 800 mg A Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. In this arm venetoclax was delivered in Cycle 1 on Days 4-10 and Cycles 2-8 on Days 1-10. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG009
Venetoclax 800 mg + G-CHOP B
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. In this arm ventoclax was delivered in Cycle 1 on Days 4-8 and Cycles 2-8 on Days 1-5. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Counts
Participants
OG0007
OG0013
OG0028
OG0036
OG004211
OG0057
OG0067
OG0076
OG0086
OG0096
Title
Denominators
Categories
Title
Measurements
OG00085.71(59.79 to 100.00)
OG001100.00(100.00 to 100.00)
OG00287.50(64.58 to 100.00)
OG00366.67(28.95 to 100.00)
OG00488.99(82.65 to 92.10)
OG005100.00(100.00 to 100.00)
OG00675.00(32.57 to 100.00)
OG007100.00(100.00 to 100.00)
OG008100.00(100.00 to 100.00)
OG009100.00(100.00 to 100.00)
OG000211
Title
Denominators
Categories
Title
Measurements
OG00037.4(30.89 to 44.35)
OG002
Venetoclax 600 mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG003
Venetoclax 800mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG004
Venetoclax + R-CHOP 800 mg Phase II
Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG005
Venetoclax 200mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG006
Venetoclax 400mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG007
Venetoclax 600mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG008
Venetoclax 800 mg + G-CHOP A
Venetoclax + G-CHOP 800 mg A Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. In this arm venetoclax was delivered in Cycle 1 on Days 4-10 and Cycles 2-8 on Days 1-10. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG009
Venetoclax 800 mg + G-CHOP B
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. In this arm ventoclax was delivered in Cycle 1 on Days 4-8 and Cycles 2-8 on Days 1-5. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Units
Counts
Participants
OG0007
OG0013
OG0028
OG0036
OG004208
OG0057
OG0067
OG0076
OG0086
OG0096
Title
Denominators
Categories
Title
Measurements
OG000100.00
OG001100.00
OG002100.00
OG003100.00
OG00499.0
OG005100.00
OG006100.00
OG007100.00
OG008100.00
OG009100.00
Units
Counts
Participants
OG000232
OG00132
Title
Denominators
Categories
Cyclophosphamide
ParticipantsOG000229
ParticipantsOG00131
Title
Measurements
OG00089.5
OG00177.4
Doxorubicin
ParticipantsOG000229
ParticipantsOG00131
Title
Measurements
OG00088.6
OG001
Vincristine
ParticipantsOG000232
ParticipantsOG00132
Title
Measurements
OG00086.6
OG001
Prednisone
ParticipantsOG000231
ParticipantsOG00132
Title
Measurements
OG00087.4
OG001
OG003
Venetoclax 800mg + R-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG004
Venetoclax + R-CHOP 800 mg Phase II
Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG005
Venetoclax 200mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG006
Venetoclax 400mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG007
Venetoclax 600mg + G-CHOP
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG008
Venetoclax + G-CHOP 800 mg
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
OG009
Venetoclax + G-CHOP 800mg B
Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days.