Study of Copanlisib in Combination With Standard Immunoch... | NCT02626455 | Trialant
NCT02626455
Sponsor
Bayer
Status
Terminated
Last Update Posted
Dec 11, 2024Actual
Enrollment
551Actual
Phase
Phase 3
Conditions
Lymphoma, Non-Hodgkin
Interventions
Copanlisib (BAY80-6946)
Placebo
Rituximab
Cyclophosphamide
Doxorubicin
Vincristine
Bendamustine
Prednisone
Countries
United States
Australia
Belgium
Brazil
Bulgaria
Canada
Chile
China
Czechia
Denmark
Finland
France
Germany
Greece
Hong Kong
Hungary
Ireland
Israel
Italy
Japan
Mexico
Poland
Portugal
Romania
Russia
Singapore
Slovakia
South Africa
South Korea
Spain
Taiwan
Thailand
Turkey (Türkiye)
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02626455
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
17833
Secondary IDs
ID
Type
Description
Link
2015-001088-38
EudraCT Number
Brief Title
Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
Official Title
A Phase III, Randomized, Double-blind, Controlled Multicenter Study of Intravenous PI3K Inhibitor Copanlisib in Combination With Standard Immunochemotherapy Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
Acronym
CHRONOS-4
Organization
BayerINDUSTRY
Status Module
Record Verification Date
Nov 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Company decided to terminate this study due to study did not meet the primary endpoint.
Expanded Access Info
No
Start Date
Jan 6, 2016Actual
Primary Completion Date
Sep 15, 2023Actual
Completion Date
Nov 10, 2023Actual
First Submitted Date
Nov 3, 2015
First Submission Date that Met QC Criteria
Dec 8, 2015
First Posted Date
Dec 10, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 8, 2024
Results First Submitted that Met QC Criteria
Nov 15, 2024
Results First Posted Date
Dec 11, 2024Actual
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
Nov 15, 2024
Last Update Posted Date
Dec 11, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BayerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess whether copanlisib in combination with standard immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone [R-CHOP]) is effective and safe, compared with placebo in combination with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have received at least one, but at most three, lines of treatment, including rituximab-based immunochemotherapy and alkylating agents.
Detailed Description
Patients should be in need of and fit for immunochemotherapy and should not be resistant to rituximab (resistance defined as lack of response or progression within 6 months of the last date of rituximab administration, including rituximab, and/or rituximab biosimilars, and/or anti-CD20 monoclonal antibody).
This study will be composed of two parts: Safety run-in and phase III part. The purpose of the safety run-in part of this study is to assess whether the drug being tested (copanlisib) in combination with standard immunochemotherapy (R-B or R-CHOP) is safe and at what dose level of the study drug (copanlisib - 45mg or 60 mg) patients are able to tolerate the study treatment combination. In addition to finding a safe and tolerable dose level for the phase III part of the study, efficacy will also be evaluated for patients that stay on the study treatment during the safety run-in. The phase III part of the study started with the determined recommended dose of copanlisib of 60 mg in combination with R-B. Combination treatment of copanlisib at the recommended/approved dose of 60 mg with R-B or R-CHOP was completed in April 2021.
A maximum of 24 patients will take part in the safety run-in part of this study. In the phase III part approximately 520 patients will be randomly assigned to blinded treatment arms of copanlisib plus R-B or R-CHOP or placebo plus R-B or R-CHOP. Combination therapy (copanlisib/placebo with R-B or R-CHOP) will be administered for a maximum of 6 cycles (C1-C6). Copanlisib/placebo (study drug) monotherapy will be administered from C7 onwards.
Conditions Module
Conditions
Lymphoma, Non-Hodgkin
Keywords
Clinical trial, Phase III
Phosphatidylinositol-3-kinase
Non-Hodgkin's lymphoma
Indolent B-cell non-Hodgkin's lymphoma
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
551Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Copanlisib + R-B or R-CHOP / Arm 1
Experimental
Combination of copanlisib with standard immunochemotherapy (rituximab and bendamustine) [R-B] or rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone [R-CHOP] (safety run-in and phase III)
Drug: Copanlisib (BAY80-6946)
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Bendamustine
Drug: Prednisone
Placebo + R-B or R-CHOP / Arm 2
Placebo Comparator
Combination of placebo and R-B or R-CHOP (phase III only)
Drug: Placebo
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Bendamustine
Drug: Prednisone
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Copanlisib (BAY80-6946)
Drug
Copanlisib is supplied as lyophilized preparation in a 6 mL injection vial. The total amount of copanlisib per vial is 60 mg. The solution for IV infusions is obtained after reconstitution with normal saline solution. For patients on R-B dosing of copanlisib will be administered on Days 1, 8 and 15 of each 28-day cycle. Copanlisib will be administered and then rituximab followed by bendamustine. For patients on R-CHOP dosing of copanlisib will be administered on Days 1 and 8 of each 21-day cycle. Treatment with copanlisib/placebo will be continued up to 12 months.
Copanlisib will be administered before rituximab followed by cyclophosphamide, doxorubicin and vincristine infusions. Prednisone/prednisolone tablets to be taken for 5 days.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
SRI: Occurrence of Dose-limiting Toxicities (DLT)
Dose-limiting toxicity is defined as any of the following occurring during Cycle 1 at a given dose level and regarded by the investigator and/or the sponsor to be possibly, probably, or definitely related to copanlisib given in combination with R-B or R-CHOP. General: any grade 5 hematologic or non-hematologic toxicity or any delay of >2 weeks of Cycle 2 due to study treatment-related toxicity; Non-hematologic DLT: any non-hematologic toxicity grade ≥ 3; Hematologic DLT: grade 4 absolute neutrophil count decrease lasting >7 days, or grade 4 febrile neutropenia, or grade 4 platelet count decreased or grade 3 platelet count decreased with serious bleeding, or signs of serious bleeding and/or international normalized ratio (INR) increased or partial thromboplastin time (PTT) prolonged of grade 3.
At Cycle 1: 28 days for Copa+R-B or 21 days for Copa+R-CHOP
Phase 3: Progression-free Survival (PFS) by Independent Central Review
PFS is defined as the time from randomization to progressive disease (PD) or death from any cause (if no progression is documented).
Approximately 6 years 4 months
Secondary Outcomes
Measure
Description
Time Frame
SRI: Best Overall Response
Best overall response is defined as the best response achieved during the treatment and active follow-up periods; prior to end of study or start of new anti-tumor treatment, whichever occurs first.
Approximately 7 years 8 months
SRI: Number of Subjects With Treatment-emergent Adverse Event (TEAE)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of B lymphocyte antigen CD20 positive iNHL with histological subtype limited to:
Follicular lymphoma G1-2-3a
Small lymphocytic lymphoma with absolute lymphocyte count <5x10E9/L at study entry
Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
Patients must have relapsed (recurrence after complete response or presented progression after partial response) or progressed after at least one but at most three prior lines of therapy, including rituximab, and/or rituximab biosimilars, and/or anti-CD20 monoclonal antibody (e.g. obinutuzumab) -based immunochemotherapy and alkylating agents (if given concomitantly is considered one line of therapy). A previous regimen is defined as one of the following: at least 2 months of single-agent therapy (less than 2 months of therapy with single agent rituximab, or rituximab biosimilars, or anti-CD20 monoclonal antibody can be considered a previous regimen in the case the patient responded to it); at least 2 consecutive cycles of polychemotherapy; autologous transplant; or radioimmunotherapy. Previous exposure to other PI3K Inhibitors (except copanlisib) is acceptable provided there is no resistance (resistance defined as no response (response defined as partial response [PR] or complete response [CR]) at any time during therapy, or progressive disease (PD) after any response (PR/CR) or after stable disease within 6 months from the end of the therapy with a PI3K inhibitor.
Non-WM patients must have at least one bi-dimensionally measurable lesion (that has not been previously irradiated) according to the Lugano Classification. For patients with splenic MZL this requirement may be restricted to splenomegaly alone since that is usually the only manifestation of measurable disease.
Patients affected by WM who do not have at least one bi-dimensionally measurable lesion in the baseline radiologic assessment must have measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level ≥ 2 x upper limit of normal and positive immunofixation test.
Male or female patients ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Life expectancy of at least 3 months
Availability of fresh tumor tissue and/or archival tumor tissue at Screening
Adequate baseline laboratory values as assessed within 7 days before starting study treatment.
Left ventricular ejection fraction ≥ 50%
Exclusion Criteria
Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed disease, or chronic lymphocytic leukemia. In patients with clinical suspicion of transformed disease, a fresh biopsy is recommended.
Rituximab, or rituximab biosimilars, or anti-CD20 monoclonal antibody (e.g. obinutuzumab) resistance at any line of therapy (resistance defined as lack of response, or progression within 6 months of the last date of rituximab, or rituximab biosimilars, or anti-CD20 monoclonal antibody administration, including maintenance with these drugs).
HbA1c > 8.5% at screening
History or concurrent condition of interstitial lung disease and/or severely impaired lung function (as judged by the investigator)
Known lymphomatous involvement of the central nervous system
Known history of human immunodeficiency virus (HIV) infection
Hepatitis B (HBV) or hepatitis C (HCV) infection. Patients positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy as per rituximab label. Patients positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at baseline will not be eligible.CMV PCR test is considered positive if, the result can be interpreted as a CMV viremia according to local standard of care.
Uncontrolled hypertension despite optimal medical management (per investigator´s assessment)
Congestive heart failure > New York Heart Association (NYHA) class 2
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Bayer Study Director
Bayer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Ironwood Physicians P.C. DBA Ironwood Cancer & Res. Ctr.
Zinzani PL, Wang H, Feng J, Kim TM, Tao R, Zhang H, Fogliatto L, Maluquer Artigal C, Ozcan M, Yanez E, Kim WS, Kirtbaya D, Kriachok I, Maciel F, Xue H, Bouabdallah K, Phelps C, Chaturvedi S, Weispfenning A, Morcos PN, Odongo F, Buvaylo V, Childs BH, Dreyling M, Matasar M, Ghione P. CHRONOS-4: phase 3 study of copanlisib plus rituximab-based immunochemotherapy in relapsed indolent B-cell lymphoma. Blood Adv. 2024 Sep 24;8(18):4866-4876. doi: 10.1182/bloodadvances.2024013236.
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
SRI: 42 participants were screened, 15 participants discontinued screening, 27 participants were enrolled and administered treatment. Phase 3: 672 participants were screened, 148 discontinued screening. 524 participants were enrolled and randomized to treatment. 4 participants were randomized but never administered, 520 participants were randomized and administered treatment.
Recruitment Details
SRI part screened 42 participants from 12 countries, between 06-Jan-2016 (first participants first visit [FPFV]) and 31-Oct-2019 (last participant first visit [LPFV]). Phase 3 part screened 672 participants from 35 countries/regions, between 06-Feb-2017 (FPFV) and 31-Mar-2020(LPFV). Study terminated on 10-Nov-2023,
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
SRI: Copa+R-B 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
FG001
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
Placebo is supplied as lyophilized preparation in a 6 mL injection vial. The developed placebo lyophilisate is equivalent to the 60 mg copanlisib formulation, with regard to the composition of excipients and the instructions for reconstitution and dose preparation. Placebo dosing will be administered as per copanlisib described above. Applies to the phase III part of the study only.
Placebo + R-B or R-CHOP / Arm 2
Rituximab
Drug
Rituximab is administered as an infusion at a dose of 375 mg/m2 body surface on Day 1 of each 28-day cycle for patients assigned to R-B and on Day 2 of each 21-day cycle for patients assigned to R-CHOP.
Copanlisib + R-B or R-CHOP / Arm 1
Placebo + R-B or R-CHOP / Arm 2
Cyclophosphamide
Drug
Cyclophosphamide is administered as an infusion at a dose of 750 mg/m2 body surface on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Copanlisib + R-B or R-CHOP / Arm 1
Placebo + R-B or R-CHOP / Arm 2
Doxorubicin
Drug
Doxorubicin is administered as an infusion at a dose of 50 mg/m2 body surface on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Copanlisib + R-B or R-CHOP / Arm 1
Placebo + R-B or R-CHOP / Arm 2
Vincristine
Drug
Vincristine is administered as an infusion at a dose of 1.4 mg/m2 body surface (maximum dose 2.0 mg) on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Copanlisib + R-B or R-CHOP / Arm 1
Placebo + R-B or R-CHOP / Arm 2
Bendamustine
Drug
Bendamustine is administered as an infusion at a dose of 90 mg/m2 body surface on Day 1 and Day 2 for patients assigned to R-B
Copanlisib + R-B or R-CHOP / Arm 1
Placebo + R-B or R-CHOP / Arm 2
Prednisone
Drug
Prednisone is given as 100 mg tablets daily from Day 2 to Day 6 for patients assigned to R-CHOP
Copanlisib + R-B or R-CHOP / Arm 1
Placebo + R-B or R-CHOP / Arm 2
A treatment-emergent AE is defined as any event arising or worsening after start of study drug administration until 30 days after the last study drug intake.
Approximately 4 years 10 months
Phase 3: Objective Tumor Response Rate (ORR)-Independent Central Review
ORR, as assessed by independent central review, is defined as the percentage of participants who had a best response rating of CR or PR according to the Lugano classification and for subjects with LPL/WM, a response rating of CR, VGPR, PR, or MR according to the Owen criteria, over the whole duration of the study (i.e., until time of analysis of PFS).
Up to 6 years 4 months
Phase 3: ORR-Investigator Assessment
ORR, as assessed by investigator, is defined as the percentage of participants who had a best response rating of CR or PR according to the Lugano classification and for subjects with LPL/WM, a response rating of CR, VGPR, PR, or MR according to the Owen criteria, over the whole duration of the study (i.e., until time of analysis of PFS).
Up to 6 years 4 months
Phase 3: Duration of Tumor Response (DOR)-Independent Central Review
DOR, as assessed by independent central review, is defined as the time (in days) from first observed tumor response (CR, VGPR, PR, or MR) until progression or death from any cause, whichever occurred earlier. The DOR was only defined for patients with at least 1 CR, VGPR, PR, or MR.
Approximately 6 years 4 months
Phase 3: DOR-Investigator Assessment
DOR, as assessed by investigator, is defined as the time (in days) from first observed tumor response (CR, VGPR, PR, or MR) until progression or death from any cause, whichever occurred earlier. The DOR was only defined for patients with at least 1 CR, VGPR, PR, or MR.
Approximately 6 years 4 months
Phase 3: Complete Tumor Response Rate (CRR)-Independent Central Review
CRR, as assessed by independent central review, is defined as the proportion of patients who had a best response rating of CR according to the Lugano classification, and for patients with LPL/WM, a response rating of CR according to the Owen criteria, over the whole duration of the study (i.e., until the time of analysis of PFS).
Approximately 6 years 4 months
Phase 3: CRR-Investigator Assessment
CRR, as assessed by investigator, is defined as the proportion of patients who had a best response rating of CR according to the Lugano classification, and for patients with LPL/WM, a response rating of CR according to the Owen criteria, over the whole duration of the study (i.e., until the time of analysis of PFS).
Approximately 6 years 4 months
Phase 3: Disease Control Rate (DCR)-Independent Central Review
DCR, as assessed by independent central review, is defined as the proportion of patients who had a best response rating of CR, VGPR, PR, MR, or stable disease (excluding unconfirmed early stable disease).
Approximately 6 years 4 months
Phase 3: DCR-Investigator Assessment
DCR, as assessed by investigator, is defined as the proportion of patients who had a best response rating of CR, VGPR, PR, MR, or stable disease (excluding unconfirmed early stable disease).
Approximately 6 years 4 months
Phase 3: Time to Tumor Progression (TTP)-Independent Central Review
TTP, as assessed by independent central review, is defined as the time from randomization to progression or death related to progression, whichever occurred earlier. Death related to progression was any death except for: death due to an AE unrelated to progression; or death with a specification of "other" as reason (which excludes PD).
Approximately 6 years 4 months
Phase 3: TTP-Investigator Assessment
TTP, as assessed by investigator, is defined as the time from randomization to progression or death related to progression, whichever occurred earlier. Death related to progression was any death except for: death due to an AE unrelated to progression; or death with a specification of "other" as reason (which excludes PD).
Approximately 6 years 4 months
Phase 3: Time to Next Anti-lymphoma Treatment (TTNT)
A new anti-lymphoma therapy is any new systemic anticancer treatment or radiotherapy for lymphoma, with a consolidation intent. TTNT was defined as the time from the date of randomization to the start of new anti-lymphoma therapy, where the date of randomization was considered Day 1.
Approximately 6 years 4 months
Phase 3: Overall Survival (OS)
Overall survival is defined as the time from randomization until death from any cause. The OS for patients alive at the time of the database cut-off date was censored to the last date they were known to be alive. Deaths that occurred after the database cut-off date, reported during data cleaning, were considered for establishing the last known alive date at data cut-off.
Approximately 6 years 4 months
Phase 3: Time to Deterioration in Disease-related Symptoms-physical (DRS-P) of at Least 3 Points of Lymphoma
Time to deterioration in DRS-P of at least 3 points, as measured by the FLymSI-18 questionnaire, was evaluated in all patients. It is defined as the time from randomization to DRS-P decline, progression, or death from any reason, whichever occurred earlier.
Approximately 6 years 4 months
Phase 3: Time to Improvement in Disease-related Symptoms-physical (DRS-P) of at Least 3 Points of Lymphoma
Time to improvement in DRS-P of at least 3 points, as measured by the FLymSI-18 questionnaire, was evaluated for all patients. It is defined as the time from randomization to DRS-P improvement of at least 3 points.
Approximately 6 years 4 months
Phase 3: Number of Subjects With Treatment-emergent Adverse Event (TEAE)
A treatment-emergent AE is defined as any event arising or worsening after start of study drug administration until 30 days after the last study drug intake.
Approximately 4 years
West Covina
California
91790
United States
SCL Health Research at St Joseph's Hospital Denver CO
Denver
Colorado
80218
United States
Lewis Hall Singletary Oncology Center
Thomasville
Georgia
31792
United States
Memorial Sloan Kettering Cancer Center- Bergen
New York
New York
10021
United States
Memorial Sloan-Kettering Cancer Center
New York
New York
10065
United States
New York Cancer and Blood Specialists
Port Jefferson Station
New York
11776
United States
Gabrail Cancer Center
Canton
Ohio
44718
United States
Oncology Consultants
Houston
Texas
77024-2645
United States
Texas Oncology- McAllen
McAllen
Texas
78503
United States
Calvary Mater Hospital Newcastle
Waratah
New South Wales
2298
Australia
Flinders Medical Centre
Bedford Park
South Australia
5042
Australia
Ashford Cancer Centre Research Pty Ltd
Kurralta Park
South Australia
5037
Australia
The Alfred Hospital
Melbourne
Victoria
3004
Australia
Fiona Stanley Hospital
Murdoch
Western Australia
6961
Australia
Eastern Health Integrated Renal Service
Box Hill
3128
Australia
Institut Jules Bordet/Jules Bordet Instituut
Brussels
1070
Belgium
UZ Gent
Ghent
9000
Belgium
UZ Leuven Gasthuisberg
Leuven
3000
Belgium
CHU de Liège
Liège
4000
Belgium
Centro Integrado de Oncologia de Curitiba
Curitiba
Paraná
80810-050
Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre | Hospital Sao Francisco - Centro Medico Pesquisa Clinica Cardiologia
Porto Alegre
Rio Grande do Sul
90020-090
Brazil
Hospital de Clinicas de Porto Alegre | Clinical Research Center - Surgery Research Center
Porto Alegre
Rio Grande do Sul
90035-903
Brazil
Centro de Pesquisas Oncológicas
Florianópolis
Santa Catarina
88034-000
Brazil
Faculdade de Ciencias Medicas-Universidade Estadual Campinas
Campinas
São Paulo
130839 970
Brazil
Centro Multidisciplinar de Estudos Clínicos EPP - Ltda.
São Bernardo do Campo
São Paulo
09715-090
Brazil
IEP São Lucas
São Paulo
São Paulo
01234-030
Brazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva
Rio de Janeiro
20231-050
Brazil
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo
05403-000
Brazil
Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department
São Paulo
05651-901
Brazil
UMHAT Sveti Georgi
Plovdiv
4000
Bulgaria
University Multiprofile Hosp. for Active Treat. Sveti Ivan
Sofia
1431
Bulgaria
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD
Sofia
1756
Bulgaria
Multiprofile Hospital for Active Treatment Hristo Botev AD
Vratsa
3000
Bulgaria
Hopital Maisonneuve-Rosemont
Montreal
Quebec
H1T 2M4
Canada
Hopital du Sacre-Coeur de Montreal
Montreal
Quebec
QC H4J 1C5
Canada
Hopital de L'Enfant Jesus
Québec
Quebec
G1J 1Z4
Canada
Centre Universitaire de Sante de l'Estrie
Sherbrooke
Quebec
J1H 5N4
Canada
Sociedad de Investigaciones Medicas Ltda
Temuco
Araucania
4810469
Chile
Centro de Investigaciones Clínicas Vina del Mar Ltda.
Viña del Mar
Valparaiso
2540364
Chile
Instituto Nacional del Cáncer
Santiago
838-0455
Chile
FuJian Medical University Union Hospital
Fuzhou
Fujian
350000
China
Guangdong Provincial People's Hospital
Guangzhou
Guangdong
510000
China
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
510000
China
Tumor Hospital of Hebei Province
Hebei
Hebei
050000
China
Henan Cancer Hospital
Zhengzhou
Henan
450000
China
Jiangsu Cancer Hospital
Nanjing
Jiangsu
210000
China
1st Affiliated hospital of Soochow University
Suzhou
Jiangsu
215000
China
Jilin Cancer Hospital
Changchun
Jilin
130000
China
The Affiliated Hospital of Qingdao University
Shandong
Shandong
266000
China
West China Hospital Sichuan University
Chengdu
Sichuan
610041
China
The 1st Affiliated Hospital of Zhejiang University
Hangzhou
Zhejiang
310000
China
Zhejiang Cancer Hospital
Hangzhou
Zhejiang
310022
China
Fifth Medical Center, General Hospital of the Chinese People
Beijing
100000
China
Beijing Friendship Hospital, Capital Medical University
Beijing
100050
China
Fudan University Shanghai Cancer Center
Shanghai
200000
China
Xinhua Hos Affiliated to SH Jiaotong Uni School of Medicine
Shanghai
200092
China
Tianjin Medical University Cancer Institute & Hospital
Tianjin
300000
China
Tianjin Union Medicine Centre (People's Hospital of Tianjin)
Centre Hospitalier Intercommunal de la Côte Basque-Bayonne
Bayonne
64100
France
Centre Hospitalier Universite de Grenoble
Grenoble
38043
France
Clinique Victor Hugo - Le Mans
Le Mans
72015
France
Hôpital Dupuytren
Limoges
87042
France
Hôpital Saint-Eloi
Montpellier
34059
France
Hopital Hotel Dieu - Nantes
Nantes
44000
France
Hôpital Saint Louis
Paris
75010
France
Centre François Magendie - Pessac
Pessac
33600
France
Hôpital de la Milétrie
Poitiers
86021
France
Clinique Saint Anne
Strasbourg
67000
France
Stauferklinikum Schwäbisch-Gmünd
Mutlangen
Baden-Wurttemberg
73557
Germany
Haematologie-Onkologie im Zentrum MVZ GmbH
Augsburg
Bavaria
86150
Germany
Klinikum der Universität München Grosshadern
München
Bavaria
81377
Germany
Medizinische Hochschule Hannover (MHH)
Hanover
Lower Saxony
30625
Germany
Marienhospital Herne Universitätsklinik
Herne
North Rhine-Westphalia
44625
Germany
Universitaetsklinikum Muenster
Münster
North Rhine-Westphalia
48149
Germany
Oncologianova GmbH
Recklinghausen
North Rhine-Westphalia
45659
Germany
Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg
Halle
Saxony-Anhalt
6120
Germany
EVANGELISMOS General Hospital of Athens
Athens
106 76
Greece
General Hospital of Athens LAIKO
Athens
11527
Greece
University General Hospital of Athens "ATTIKON"
Chaïdári
12462
Greece
Univ. General Hospital of Larissa
Larissa
41110
Greece
University General Hospital of Patras
Pátrai
26500
Greece
Prince of Wales Hospital
Hong Kong
MISSING
Hong Kong
Semmelweis University
Budapest
1083
Hungary
Orszagos Onkologiai Intezet
Budapest
1122
Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár
7400
Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Nyíregyháza
4400
Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs
7623
Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya
2800
Hungary
Cork University Hospital
Cork
T12DC4A
Ireland
Mater Misericordiae University Hospital
Dublin
D07R2WY
Ireland
Rambam Health Corporation
Haifa
3109601
Israel
Hadassah Hebrew University Hospital Ein Kerem
Jerusalem
9112001
Israel
Chaim Sheba Medical Center
Ramat Gan
5262000
Israel
Shamir Medical Center (Assaf Harofeh)
Ẕerifin
7030000
Israel
IRCCS Ospedale Policlinico San Martino
Genoa
Liguria
16132
Italy
Humanitas Mirasole S.p.A.
Milan
Lombardy
20089
Italy
IRCCS Fondazione Policlinico San Matteo
Pavia
Lombardy
27100
Italy
A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"
Ancona
The Marches
60126
Italy
Aichi Cancer Center Hospital
Nagoya
Aichi-ken
464-8681
Japan
Nagoya City University Hospital
Nagoya
Aichi-ken
467-8602
Japan
JCHO Kyushu Hospital
Kitakyushu
Fukuoka
806-8501
Japan
Gunma University Hospital
Maebashi
Gunma
371-8511
Japan
Hyogo Cancer Center
Akashi
Hyōgo
673-8558
Japan
Kobe University Hospital
Kobe
Hyōgo
650-0017
Japan
Kanagawa Cancer Center
Yokohama
Kanagawa
241-8515
Japan
Tohoku University Hospital
Sendai
Miyagi
980-8574
Japan
Tenri Hospital
Tenri
Nara
632-8552
Japan
Kindai University Hospital
Osakasayama-shi
Osaka
589-8511
Japan
Saitama Medical University International Medical Center
Hidaka
Saitama
350-1298
Japan
National Cancer Center Hospital
Chuo-ku
Tokyo
104-0045
Japan
Aomori Prefectural Central Hospital
Aomori
030-8553
Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka
811-1395
Japan
Hiroshima Red Cross & Atomic-bomb Survivors Hospital
Hiroshima
730-8619
Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto
860-0008
Japan
Kumamoto University Hospital
Kumamoto
860-8556
Japan
Osaka Red Cross Hospital
Osaka
543-8555
Japan
Osaka Metropolitan University Hospital
Osaka
545-8586
Japan
Yamagata University Hospital
Yamagata
990-9585
Japan
Hospital General de México SS
México, D. F.
Mexico City
6726
Mexico
Centro de Investigación Clínica Chapultepec S.A. de C.V.
Morelia
Michoacán
58260
Mexico
Hospital Universitario "José Eleuterio González"
Monterrey
Nuevo León
TBC
Mexico
Centro Especializado en Investigación Clínica S.C.
Boca del Río
Veracruz
94290
Mexico
Centro de Atencion e Investigacion Clinica en Oncologia SCP
Mérida
Yucatán
97134
Mexico
Szpital Morski im. PCK
Gdynia
81-519
Poland
Pratia McM Kraków
Krakow
30-727
Poland
Wojew. Szpital Specjalistyczny im. M. Kopernika
Lodz
93-513
Poland
Centro Clinico Academico Braga | Braga, Portugal
Braga
4710-243
Portugal
Centro Hospitalar Universitario do Porto
Porto
4099-001
Portugal
IPO Porto
Porto
4200-072
Portugal
Centro Hospitalar Vila Nova de Gaia e Espinho | Unit 1 - Clinical Research Center
Porto
4434-502
Portugal
Sp. Judetean de Urgenta Dr. Constantin Opris Baia Mare
Baia Mare
430031
Romania
Sc Onco Card Srl
Brasov
500152
Romania
Spitalul Clinic Colentina
Bucharest
20125
Romania
Fundeni Clinical Institute
Bucharest
22328
Romania
Spitalul Clinic Coltea
Bucharest
30171
Romania
Spitalul Clinic Municipal Filantropia Craiova
Craiova
200143
Romania
Institutul Regional de Oncologie Iasi
Iași
700483
Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu
550245
Romania
Kemerovo Regional Clinical Hospital
Kemerovo
650066
Russia
Clinical Oncological Dispensary of Omsk Region
Omsk
644013
Russia
Research Institute of Oncology
Rostov-on-Don
344037
Russia
RSRI of Hematology and Transfusiology
Saint Petersburg
191024
Russia
Oncology Dispensary #2
Sochi
354057
Russia
Siberian State Medical University
Tomsk
634050
Russia
Republican Clinical Oncology Dispensary
Ufa
450054
Russia
National University Hospital
Singapore
119074
Singapore
National Cancer Center Singapore
Singapore
168583
Singapore
Singapore General Hospital
Singapore
169608
Singapore
Narodny onkologicky ustav
Bratislava
833 10
Slovakia
Outeniqua Cancercare Oncology Unit
George
Eastern Cape
6530
South Africa
Cancercare Langenhoven
Port Elizabeth
Eastern Cape
6045
South Africa
Albert Alberts Stem Cell Transplant Research Centre
Pretoria
Gauteng
44
South Africa
Constantiaberg Medi Clinic
Cape Town
Western Cape
7800
South Africa
Seoul National University Hospital
Seoul
Seoul Teugbyeolsi
3080
South Korea
Severance Hospital, Yonsei University Health System
Seoul
03722
South Korea
Asan Medical Center
Seoul
138-736
South Korea
Samsung Medical Center
Seoul
6351
South Korea
Institut Català d'Oncologia Badalona
Badalona
Barcelona
8916
Spain
Institut Català d'Oncologia Hospitalet
L'Hospitalet de Llobregat
Barcelona
08907
Spain
Hospital Universitario Clinica Puerta de Hierro
Majadahonda
Madrid
28222
Spain
Hospital Regional de Malaga | Oncologia
Málaga
Málaga
29010
Spain
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
Barcelona
08035
Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza
50009
Spain
Changhua Christian Hospital
Changhua
50006
Taiwan
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City
833
Taiwan
National Cheng Kung University Hospital
Tainan
704
Taiwan
National Taiwan University Hospital
Taipei
100
Taiwan
Taipei Veterans General Hospital
Taipei
11217
Taiwan
Phramongkutklao Hospital
Bangkok
10400
Thailand
Siriraj Hospital, Mahidol
Bangkok
10700
Thailand
Ankara Universitesi Tip Fakultesi Hastanesi
Ankara
6100
Turkey (Türkiye)
Trakya Univ. Tip Fak.
Edirne
22030
Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul
34093
Turkey (Türkiye)
Marmara Uni. Tip Fak. Pendik EAH Hematoloji BD
Istanbul
34899
Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi
Izmir
35100
Turkey (Türkiye)
Ege Universitesi Tip Fakultesi
Izmir
35100
Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi
Kayseri
38039
Turkey (Türkiye)
Ondokuz Mayis Uni Tip Fakultesi
Samsun
55139
Turkey (Türkiye)
Karadeniz Teknik Universitesi Tip Fakultesi
Trabzon
61080
Turkey (Türkiye)
CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council"
Cherkasy
18009
Ukraine
Municipal Non-Profit Enterprise "City Clinical Hospital ?4" of the Dnipro City Council
Dnipro
49102
Ukraine
Clinic of National cancer institute - scientific and research department of pediatric oncology
Kyiv
03022
Ukraine
State Institution - Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine
Lviv
79044
Ukraine
CNE "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia regional council
Zaporizhzhya
69600
Ukraine
Royal Devon & Exeter Hospital
Exeter
Devon
EX2 5DW
United Kingdom
Northwick Park Hospital
Harrow
London
HA1 3UJ
United Kingdom
St George's Hospital
Kogarah
London
2217
United Kingdom
Dorset County Hospital
Dorchester
DT1 2JY
United Kingdom
Royal Marsden Hospital (London)
London
SW3 6JJ
United Kingdom
Singleton Hospital
Swansea
SA2 8QA
United Kingdom
Derived
Matasar MJ, Dreyling M, Leppa S, Santoro A, Pedersen M, Buvaylo V, Fletcher M, Childs BH, Zinzani PL. Feasibility of Combining the Phosphatidylinositol 3-Kinase Inhibitor Copanlisib With Rituximab-Based Immunochemotherapy in Patients With Relapsed Indolent B-cell Lymphoma. Clin Lymphoma Myeloma Leuk. 2021 Nov;21(11):e886-e894. doi: 10.1016/j.clml.2021.06.021. Epub 2021 Jul 2.
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
FG002
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
FG003
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
FG004
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
FG005
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
FG006
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
FG0003 subjects
FG0017 subjects
FG0025 subjects
FG0036 subjects
FG0046 subjects
FG005262 subjects
FG006262 subjects
COMPLETED
FG0000 subjects
FG0012 subjects
FG0023 subjects
FG0032 subjects
FG0043 subjects
FG005108 subjects
FG006153 subjects
NOT COMPLETED
FG0003 subjects
FG0015 subjects
FG0022 subjects
FG0034 subjects
FG0043 subjects
FG005154 subjects
FG006109 subjects
Type
Comment
Reasons
Other
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00517 subjects
FG00623 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
Patient decision: COVID-19 pandemic related
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Physician decision: COVID-19 pandemic related
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Logistical reason: COVID-19 pandemic related
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Patient decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive disease - radiological progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Progressive disease - clinical progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
AE not associated with clinical disease progression
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
AE associated with clinical disease progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Study intervention never administered
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
FAS
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
SRI: Copa+R-B 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
BG001
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
BG002
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
BG003
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
BG004
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
BG005
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
BG006
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0017
BG0025
BG0036
BG0046
BG005262
BG006262
BG007551
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0015
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
SRI: Occurrence of Dose-limiting Toxicities (DLT)
Dose-limiting toxicity is defined as any of the following occurring during Cycle 1 at a given dose level and regarded by the investigator and/or the sponsor to be possibly, probably, or definitely related to copanlisib given in combination with R-B or R-CHOP. General: any grade 5 hematologic or non-hematologic toxicity or any delay of >2 weeks of Cycle 2 due to study treatment-related toxicity; Non-hematologic DLT: any non-hematologic toxicity grade ≥ 3; Hematologic DLT: grade 4 absolute neutrophil count decrease lasting >7 days, or grade 4 febrile neutropenia, or grade 4 platelet count decreased or grade 3 platelet count decreased with serious bleeding, or signs of serious bleeding and/or international normalized ratio (INR) increased or partial thromboplastin time (PTT) prolonged of grade 3.
Posted
Number
Percentage
At Cycle 1: 28 days for Copa+R-B or 21 days for Copa+R-CHOP
ID
Title
Description
OG000
SRI: Copa+R-B 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
OG001
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
OG002
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
OG003
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
OG004
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
Units
Counts
Participants
OG0003
OG0017
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Phase 3: Progression-free Survival (PFS) by Independent Central Review
PFS is defined as the time from randomization to progressive disease (PD) or death from any cause (if no progression is documented).
Posted
Median
95% Confidence Interval
Months
Approximately 6 years 4 months
ID
Title
Description
OG000
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
OG001
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
Units
Counts
Participants
Secondary
SRI: Best Overall Response
Best overall response is defined as the best response achieved during the treatment and active follow-up periods; prior to end of study or start of new anti-tumor treatment, whichever occurs first.
Posted
Number
95% Confidence Interval
Percentage
Approximately 7 years 8 months
ID
Title
Description
OG000
SRI: Copa+R-B 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
OG001
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
OG002
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
OG003
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
OG004
Secondary
SRI: Number of Subjects With Treatment-emergent Adverse Event (TEAE)
A treatment-emergent AE is defined as any event arising or worsening after start of study drug administration until 30 days after the last study drug intake.
Posted
Count of Participants
Participants
Approximately 4 years 10 months
ID
Title
Description
OG000
SRI: Copa+R-B 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
OG001
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
OG002
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
OG003
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
OG004
Secondary
Phase 3: Objective Tumor Response Rate (ORR)-Independent Central Review
ORR, as assessed by independent central review, is defined as the percentage of participants who had a best response rating of CR or PR according to the Lugano classification and for subjects with LPL/WM, a response rating of CR, VGPR, PR, or MR according to the Owen criteria, over the whole duration of the study (i.e., until time of analysis of PFS).
Posted
Number
95% Confidence Interval
Percentage
Up to 6 years 4 months
ID
Title
Description
OG000
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
OG001
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
Units
Counts
Secondary
Phase 3: ORR-Investigator Assessment
ORR, as assessed by investigator, is defined as the percentage of participants who had a best response rating of CR or PR according to the Lugano classification and for subjects with LPL/WM, a response rating of CR, VGPR, PR, or MR according to the Owen criteria, over the whole duration of the study (i.e., until time of analysis of PFS).
Posted
Number
95% Confidence Interval
Percentage
Up to 6 years 4 months
ID
Title
Description
OG000
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
OG001
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
Units
Counts
Secondary
Phase 3: Duration of Tumor Response (DOR)-Independent Central Review
DOR, as assessed by independent central review, is defined as the time (in days) from first observed tumor response (CR, VGPR, PR, or MR) until progression or death from any cause, whichever occurred earlier. The DOR was only defined for patients with at least 1 CR, VGPR, PR, or MR.
Posted
Median
95% Confidence Interval
Months
Approximately 6 years 4 months
ID
Title
Description
OG000
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
OG001
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
Units
Counts
Participants
Secondary
Phase 3: DOR-Investigator Assessment
DOR, as assessed by investigator, is defined as the time (in days) from first observed tumor response (CR, VGPR, PR, or MR) until progression or death from any cause, whichever occurred earlier. The DOR was only defined for patients with at least 1 CR, VGPR, PR, or MR.
Posted
Median
95% Confidence Interval
Months
Approximately 6 years 4 months
ID
Title
Description
OG000
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
OG001
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
Units
Counts
Participants
Secondary
Phase 3: Complete Tumor Response Rate (CRR)-Independent Central Review
CRR, as assessed by independent central review, is defined as the proportion of patients who had a best response rating of CR according to the Lugano classification, and for patients with LPL/WM, a response rating of CR according to the Owen criteria, over the whole duration of the study (i.e., until the time of analysis of PFS).
Posted
Number
95% Confidence Interval
Percentage
Approximately 6 years 4 months
ID
Title
Description
OG000
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
OG001
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
Units
Counts
Secondary
Phase 3: CRR-Investigator Assessment
CRR, as assessed by investigator, is defined as the proportion of patients who had a best response rating of CR according to the Lugano classification, and for patients with LPL/WM, a response rating of CR according to the Owen criteria, over the whole duration of the study (i.e., until the time of analysis of PFS).
Posted
Number
95% Confidence Interval
Percentage
Approximately 6 years 4 months
ID
Title
Description
OG000
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
OG001
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
Units
Counts
Participants
Secondary
Phase 3: Disease Control Rate (DCR)-Independent Central Review
DCR, as assessed by independent central review, is defined as the proportion of patients who had a best response rating of CR, VGPR, PR, MR, or stable disease (excluding unconfirmed early stable disease).
Posted
Number
95% Confidence Interval
Percentage
Approximately 6 years 4 months
ID
Title
Description
OG000
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
OG001
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
Units
Counts
Participants
Secondary
Phase 3: DCR-Investigator Assessment
DCR, as assessed by investigator, is defined as the proportion of patients who had a best response rating of CR, VGPR, PR, MR, or stable disease (excluding unconfirmed early stable disease).
Posted
Number
95% Confidence Interval
Percentage
Approximately 6 years 4 months
ID
Title
Description
OG000
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
OG001
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
Units
Counts
Participants
Secondary
Phase 3: Time to Tumor Progression (TTP)-Independent Central Review
TTP, as assessed by independent central review, is defined as the time from randomization to progression or death related to progression, whichever occurred earlier. Death related to progression was any death except for: death due to an AE unrelated to progression; or death with a specification of "other" as reason (which excludes PD).
Posted
Median
95% Confidence Interval
Months
Approximately 6 years 4 months
ID
Title
Description
OG000
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
OG001
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
Units
Counts
Secondary
Phase 3: TTP-Investigator Assessment
TTP, as assessed by investigator, is defined as the time from randomization to progression or death related to progression, whichever occurred earlier. Death related to progression was any death except for: death due to an AE unrelated to progression; or death with a specification of "other" as reason (which excludes PD).
Posted
Median
95% Confidence Interval
Months
Approximately 6 years 4 months
ID
Title
Description
OG000
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
OG001
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
Units
Counts
Participants
Secondary
Phase 3: Time to Next Anti-lymphoma Treatment (TTNT)
A new anti-lymphoma therapy is any new systemic anticancer treatment or radiotherapy for lymphoma, with a consolidation intent. TTNT was defined as the time from the date of randomization to the start of new anti-lymphoma therapy, where the date of randomization was considered Day 1.
Posted
Median
95% Confidence Interval
Months
Approximately 6 years 4 months
ID
Title
Description
OG000
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
OG001
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
Units
Counts
Participants
Secondary
Phase 3: Overall Survival (OS)
Overall survival is defined as the time from randomization until death from any cause. The OS for patients alive at the time of the database cut-off date was censored to the last date they were known to be alive. Deaths that occurred after the database cut-off date, reported during data cleaning, were considered for establishing the last known alive date at data cut-off.
Posted
Median
95% Confidence Interval
Months
Approximately 6 years 4 months
ID
Title
Description
OG000
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
OG001
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
Units
Counts
Secondary
Phase 3: Time to Deterioration in Disease-related Symptoms-physical (DRS-P) of at Least 3 Points of Lymphoma
Time to deterioration in DRS-P of at least 3 points, as measured by the FLymSI-18 questionnaire, was evaluated in all patients. It is defined as the time from randomization to DRS-P decline, progression, or death from any reason, whichever occurred earlier.
Posted
Median
95% Confidence Interval
Months
Approximately 6 years 4 months
ID
Title
Description
OG000
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
OG001
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
Units
Counts
Participants
Secondary
Phase 3: Time to Improvement in Disease-related Symptoms-physical (DRS-P) of at Least 3 Points of Lymphoma
Time to improvement in DRS-P of at least 3 points, as measured by the FLymSI-18 questionnaire, was evaluated for all patients. It is defined as the time from randomization to DRS-P improvement of at least 3 points.
Posted
Median
95% Confidence Interval
Months
Approximately 6 years 4 months
ID
Title
Description
OG000
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
OG001
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
Units
Counts
Participants
Secondary
Phase 3: Number of Subjects With Treatment-emergent Adverse Event (TEAE)
A treatment-emergent AE is defined as any event arising or worsening after start of study drug administration until 30 days after the last study drug intake.
Posted
Count of Participants
Participants
Approximately 4 years
ID
Title
Description
OG000
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
OG001
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
Units
Counts
Participants
Time Frame
After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Description
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
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
SRI: Copa+R-B 45 mg
In SRI part, subjects received 45 mg of copanlisib in combination with R-B.
1
3
2
3
3
3
EG001
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
In SRI part, subjects received 60 mg of copanlisib in combination with R-B.
0
7
3
7
7
7
EG002
SRI: Copa+R-CHOP 45 mg
In SRI part, subjects received 45 mg of copanlisib in combination with R-CHOP.
0
5
3
5
5
5
EG003
SRI: Copa+R-CHOP 60 mg
In SRI part, subjects received 60 mg of copanlisib in combination with R-CHOP.
1
6
6
6
6
6
EG004
SRI: Japan Copa+R-B 60 mg
In SRI part, Subjects from Japan only received 60 mg of copanlisib in combination with R-B.
0
6
3
6
6
6
EG005
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
68
263
161
263
259
263
EG006
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
62
257
54
257
250
257
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0053 events3 affected263 at risk
EG0064 events2 affected257 at risk
Eosinophilia
Blood and lymphatic system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Haemolysis
Blood and lymphatic system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Myelosuppression
Blood and lymphatic system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Bone marrow failure
Blood and lymphatic system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Uveitis
Eye disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Chest pain
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Chills
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Hyperthermia
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Malaise
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Oedema peripheral
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0022 events1 affected5 at risk
EG003
General physical health deterioration
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Inflammation
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Device related thrombosis
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Cholangitis acute
Hepatobiliary disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Gallbladder disorder
Hepatobiliary disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Infusion related hypersensitivity reaction
Immune system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Cytomegalovirus infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Diarrhoea infectious
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Disseminated cryptococcosis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Epididymitis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Genital herpes
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Influenza
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Laryngitis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Meningitis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Meningitis cryptococcal
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonia cytomegaloviral
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Rash pustular
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Sepsis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Skin infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Varicella
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Ludwig angina
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Anal abscess
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Cytomegalovirus colitis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Febrile infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Pneumococcal sepsis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Hepatic infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Infective thrombosis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Cytomegalovirus infection reactivation
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Enteritis infectious
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Cytomegalovirus viraemia
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Viraemia
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Respiratory tract infection fungal
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Anorectal infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Device related infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Herpes zoster disseminated
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Large intestine infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract candidiasis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
COVID-19
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Amylase increased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Platelet count decreased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Cytomegalovirus test positive
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Norovirus test positive
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Kaposi's sarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Coma
Nervous system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Syncope
Nervous system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Dermatitis exfoliative generalised
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Stevens-Johnson syndrome
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Toxic skin eruption
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Skin toxicity
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Haematoma
Vascular disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Hypertension
Vascular disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Hypotension
Vascular disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0002 events2 affected3 at risk
EG00110 events3 affected7 at risk
EG0023 events2 affected5 at risk
EG0035 events3 affected6 at risk
EG0040 events0 affected6 at risk
EG005166 events85 affected263 at risk
EG006147 events64 affected257 at risk
Eosinophilia
Blood and lymphatic system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0002 events1 affected3 at risk
EG0018 events1 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events1 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0005 events2 affected3 at risk
EG00124 events5 affected7 at risk
EG00220 events4 affected5 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0003 events2 affected3 at risk
EG0017 events3 affected7 at risk
EG0028 events2 affected5 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (26.0)
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Dry eye
Eye disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Uveitis
Eye disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0014 events2 affected7 at risk
EG0025 events3 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0004 events1 affected3 at risk
EG0015 events3 affected7 at risk
EG0025 events3 affected5 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0006 events3 affected3 at risk
EG0018 events5 affected7 at risk
EG0023 events3 affected5 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0002 events2 affected3 at risk
EG0015 events4 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Asthenia
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0016 events2 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Chills
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Face oedema
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Fatigue
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0003 events2 affected3 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Injection site reaction
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Malaise
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0016 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Oedema
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0016 events4 affected7 at risk
EG0022 events2 affected5 at risk
EG003
Swelling face
General disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Contrast media allergy
Immune system disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Cytomegalovirus infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Genital herpes
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Influenza
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0022 events2 affected5 at risk
EG003
Cytomegalovirus infection reactivation
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Borrelia infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Erythema migrans
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Device related sepsis
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Candida infection
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Herpes simplex reactivation
Infections and infestations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events3 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Amylase increased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0002 events1 affected3 at risk
EG0013 events3 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
CD4 lymphocytes decreased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Lipase increased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events3 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Platelet count decreased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0025 events1 affected5 at risk
EG003
Weight decreased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Cytomegalovirus test positive
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Troponin I increased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Inflammatory marker increased
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Pseudomonas test positive
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Norovirus test positive
Investigations
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Non-systematic Assessment
EG0002 events1 affected3 at risk
EG00115 events6 affected7 at risk
EG0028 events5 affected5 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0023 events2 affected5 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events2 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0017 events3 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected5 at risk
EG003
Limb mass
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected5 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)