Brightline-1: A Study to Compare Brigimadlin (BI 907828)... | NCT05218499 | Trialant
NCT05218499
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Mar 2, 2026Actual
Enrollment
400Actual
Phase
Phase 2Phase 3
Conditions
Liposarcoma, Dedifferentiated
Interventions
Brigimadlin
Doxorubicin
Countries
United States
Australia
Belgium
Canada
China
Czechia
Denmark
Finland
France
Germany
Greece
Hong Kong
Italy
Japan
Netherlands
Norway
Portugal
Spain
Sweden
Taiwan
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT05218499
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1403-0008
Secondary IDs
ID
Type
Description
Link
2021-002392-20
EudraCT Number
Brief Title
Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma
Official Title
Brightline-1: A Phase II/III, Randomized, Open-label, Multi-center Study of Brigimadlin (BI 907828) Compared to Doxorubicin as First Line Treatment of Patients With Advanced Dedifferentiated Liposarcoma
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Feb 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 31, 2022Actual
Primary Completion Date
Apr 16, 2024Actual
Completion Date
Jan 26, 2026Actual
First Submitted Date
Jan 18, 2022
First Submission Date that Met QC Criteria
Jan 31, 2022
First Posted Date
Feb 1, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Apr 1, 2025
Results First Submitted that Met QC Criteria
Jun 18, 2025
Results First Posted Date
Jul 4, 2025Actual
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
Feb 17, 2026
Last Update Posted Date
Mar 2, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate.
The purpose of this study is to compare a medicine called brigimadlin (BI 907828) with doxorubicin in people with liposarcoma. Brigimadlin (BI 907828) is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma.
During the study, participants get either brigimadlin (BI 907828) or doxorubicin. Every 3 weeks, participants take brigimadlin (BI 907828) as tablets or doxorubicin as an infusion into a vein. Participants can switch to brigimadlin (BI 907828) treatment if they did not benefit from doxorubicin treatment.
Participants can continue treatment in the study as long as they benefit from it and can tolerate it.
Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.
Detailed Description
Not provided
Conditions Module
Conditions
Liposarcoma, Dedifferentiated
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
400Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Brigimadlin 30 mg q3w
Experimental
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 30 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
Drug: Brigimadlin
Brigimadlin 45 mg q3w
Experimental
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
Drug: Brigimadlin
Doxorubicin
Active Comparator
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
Drug: Doxorubicin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Brigimadlin
Drug
Brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
Brigimadlin 30 mg q3w
Brigimadlin 45 mg q3w
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Progression-free Survival (PFS)
Progression-free survival (PFS) based on blinded central independent review. For each patient, PFS was defined as the time interval from randomization until tumor progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (solely based on blinded central independent review) or death from any cause, whichever occurs first.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter. (Note: the appearance of one or more new lesions is also considered progression).
Up to 20.6 months.
Secondary Outcomes
Measure
Description
Time Frame
Objective Response (OR)
Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1 (based on blinded central independent review) from the date of randomization until disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated, written informed consent form (ICF) in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses.
Male or female patients ≥18 years old at the time of signature of the informed consent form (ICF). Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use 2 medically acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at screening, during trial participation, and until 6 months and 12 days after last dose for women and 102 days after last dose for men. A list of contraception methods meeting these criteria is provided in the patient information.
Histologically proven locally advanced or metastatic, unresectable (surgery morbidity would outweigh potential benefits), progressive or recurrent dedifferentiated liposarcoma (DDLPS). Locally performed histopathological diagnosis will be accepted for entry into this trial but will be confirmed by independent pathological review while the patients receive treatment in this trial.
Written pathology report indicating the diagnosis of DDLPS with positive mouse double minute 2 homolog (MDM2) immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridization or next generation sequencing (NGS) must be available.
Formalin fixed paraffin embedded tumor blocks or slides must be available for retrospective histopathological central review.
Presence of at least one measurable target lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. In patients who only have one target lesion, the baseline imaging must be performed at least 2 weeks after any biopsy of the target lesion.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Patient must be willing to donate blood samples for the pharmacokinetics, pharmacodynamics, and tumor mutation analysis.
Patient willing to undergo a mandatory tumor biopsy at the time point specified in the flowchart unless exempt.
Adequate organ function.
Exclusion Criteria:
Known mutation in the TP53 gene (screening for TP53 status is not required).
Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening.
Prior systemic therapy for liposarcoma in any setting (including adjuvant, neoadjuvant, maintenance, palliative).
Previous or concomitant malignancies other than DDLPS or WDLPS, treated within the previous 5 years, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ, or other malignancy that is considered cured by local treatment.
Previous treatment with anthracyclines in any setting (systemic treatment with other anticancer agents is allowed if completed at least 5 years prior to study entry with the exception of hormone therapy).
Patients who must or intend to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s) or receiving other investigational treatment(s).
Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the patient an unreliable trial participant).
Schoffski P, Lahmar M, Lucarelli A, Maki RG. Brightline-1: phase II/III trial of the MDM2-p53 antagonist BI 907828 versus doxorubicin in patients with advanced DDLPS. Future Oncol. 2023 Mar;19(9):621-629. doi: 10.2217/fon-2022-1291. Epub 2023 Mar 29.
Once the time frame criteria given under number 4 are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'.
For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Recruitment Details
This was a randomized, active-controlled, open-label, global trial with a seamless Phase II part and Phase III part parallel design.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Brigimadlin 30 mg q3w
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 30 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
FG001
Brigimadlin 45 mg q3w
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 2, 2024
Jun 17, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Ireland
Philippines
Russia
South Korea
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
BI 907828
Doxorubicin
Drug
Intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
Doxorubicin
Up to 20.6 months.
Duration of Objective Response (DOR)
Duration of objective response (DOR), defined as the time interval from first documented confirmed OR until disease progression or death among patients with confirmed OR (based on blinded central independent review), whichever occurs first.
Up to 20.6 months.
Disease Control (DC)
Disease control (DC), defined as a best overall response of CR, PR, or stable disease (SD) according to RECIST version 1.1 (based on blinded central independent review).
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Up to 20.6 months.
Change in Health-Related Quality of Life at Week 6 and 18
Mean change from baseline to week 6 and 18 in the following European Organization for Research and Treatment on Cancer (EORTC) Quality of Life Core Questionnaire 30 items (QLQ-C30) scores:
Physical functioning (higher score is better)
Pain (higher score is worse)
Fatigue (higher score is worse)
Global health status / QoL (higher score is better)
and the following scores obtained using items from the EORTC QLQ-C30 and EORTC Item Library (higher score is worse):
Fatigue symptoms
Fatigability
Fatigue impact
Pain descriptors
Pain impact
All of the scales and single-item measures range in score from 0 to 100.
Baseline (cycle 1 day 1), week 6 and week 18.
Tucson
Arizona
85719
United States
Precision NextGen Oncology
Beverly Hills
California
90212
United States
City of Hope-Duarte-56419
Duarte
California
91010
United States
University of Southern California
Los Angeles
California
90033
United States
Sarcoma Oncology Center
Santa Monica
California
90403
United States
Mayo Clinic Cancer Center
Jacksonville
Florida
32224
United States
Winship Cancer Institute
Atlanta
Georgia
30322
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Dana-Farber Cancer Institute
Boston
Massachusetts
02215
United States
University of Michigan Health System
Ann Arbor
Michigan
48109
United States
Mayo Clinic, Rochester
Rochester
Minnesota
55905
United States
Barnes-Jewish Hospital
St Louis
Missouri
63110
United States
Nebraska Cancer Specialists-Omaha-69502
Omaha
Nebraska
68114
United States
University Hospitals of Cleveland
Cleveland
Ohio
44106
United States
Oregon Health and Sciences University
Portland
Oregon
97239
United States
Henry-Joyce Cancer Clinic
Nashville
Tennessee
37232
United States
University of Texas Southwestern Medical Center
Dallas
Texas
75390
United States
Huntsman Cancer Institute
Salt Lake City
Utah
84112
United States
Froedtert and The Medical College of Wisconsin
Milwaukee
Wisconsin
53226
United States
Prince of Wales Hospital-Randwick-66496
Randwick
New South Wales
2031
Australia
Princess Alexandra Hospital
Woolloongabba
Queensland
4102
Australia
Ashford Cancer Centre Research
Kurralta Park
South Australia
5037
Australia
Peter MacCallum Cancer Centre
Melbourne
Victoria
3000
Australia
UZ Leuven
Leuven
3000
Belgium
BC Cancer Agency - Vancouver
Vancouver
British Columbia
V5Z 4E6
Canada
The Ottawa Hospital
Ottawa
Ontario
K1H 8L6
Canada
Princess Margaret Cancer Centre
Toronto
Ontario
M5G 2M9
Canada
Maisonneuve-Rosemont Hospital
Montreal
Quebec
H1T 2M4
Canada
Cancer Hospital of Chinese Academy of Medical Science
Beijing
100021
China
Beijing Cancer Hospital
Beijing
100142
China
The First Hospital of Jilin University
Changchun
130021
China
West China Hospital, Sichuan University
Chengdu
610041
China
Sun Yat-Sen University Cancer Center
Guangzhou
510060
China
Zhejiang Cancer Hospital
Hangzhou
310022
China
Harbin Medical University Cancer Hospital
Harbin
150081
China
Zhongshan Hospital Affiliated to Fudan University
Shanghai
200032
China
Wuhan Union Hospital
Wuhan
430022
China
Masaryk Memorial Cancer Institute
Brno
65653
Czechia
University Hospital Olomouc
Olomouc
77900
Czechia
University Hospital Motol
Prague
150 06
Czechia
Herlev and Gentofte Hospital
Herlev
2730
Denmark
HUCH Comprehensive Cancer Center, building 2
Helsinki
00290
Finland
Tampere University Hospital
Tampere
33520
Finland
INS Bergonie
Bordeaux
33000
France
CTR Oscar Lambret
Lille
59020
France
CTR Leon Berard
Lyon
69373
France
HOP Timone
Marseille
13385
France
Hôpital Cochin
Paris
75014
France
CTR Eugène Marquis
Rennes
35042
France
INS Claudius Regaud IUCT-Oncopole
Toulouse
31059
France
Institut Gustave Roussy
Villejuif
94805
France
Helios Klinikum Bad Saarow
Bad Saarow
15526
Germany
Helios Klinikum Berlin-Buch
Berlin
13125
Germany
Technische Universität Dresden
Dresden
01307
Germany
Universitätsklinikum Essen AöR
Essen
45147
Germany
Asklepios Kliniken GmbH & Co. KGaA
Hamburg
22763
Germany
Medizinische Hochschule Hannover
Hanover
30625
Germany
Universitätsklinikum Mannheim GmbH
Mannheim
68167
Germany
Klinikum der Universität München AÖR
München
81377
Germany
Robert Bosch Gesellschaft für medizinische Forschung mbH
Stuttgart
70376
Germany
Hippokration General Hospital of Athen
Athens
115 27
Greece
"Attikon" University General Hospital of Attica
Haidari
12462
Greece
Bioclinic Thessaloniki
Thessaloniki
54622
Greece
Prince of Wales Hospital-Hong Kong-20715
Hong Kong
Hong Kong
Humanitas Gavazzeni
Bergamo
24125
Italy
Istituto Di Candiolo
Candiolo (TO)
10060
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
20133
Italy
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Naples
80131
Italy
AOU San Luigi Gonzaga
Orbassano (TO)
10043
Italy
Istituto Oncologico Veneto IRCCS
Padova
35128
Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo
90129
Italy
Università Campus Bio-Medico - ROMA
Roma
00128
Italy
Aichi Cancer Center Hospital
Aichi, Nagoya
464-8681
Japan
Nagoya University Hospital
Aichi, Nagoya
466-8560
Japan
National Cancer Center Hospital East
Chiba, Kashiwa
277-8577
Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka
811-1395
Japan
Kyushu University Hospital
Fukuoka, Fukuoka
812-8582
Japan
Tohoku University Hospital
Miyagi, Sendai
980-8574
Japan
Okayama University Hospital
Okayama, Okayama
700-8558
Japan
Osaka International Cancer Institute
Osaka, Osaka
541-8567
Japan
Hokkaido Cancer Center
Sapporo, Hokkaido
003-0804
Japan
National Cancer Center Hospital
Tokyo, Chuo-ku
104-0045
Japan
Japanese Foundation for Cancer Research
Tokyo, Koto-ku
135-8550
Japan
Nederlands Kanker Instituut
Amsterdam
1066 CX
Netherlands
Leids Universitair Medisch Centrum (LUMC)
Leiden
2333 ZA
Netherlands
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo
N-0379
Norway
IPO Lisboa Francisco Gentil, EPE
Lisbon
1099-023
Portugal
ULS de Santa Maria, E.P.E
Lisbon
1649-035
Portugal
Hospital Santa Creu i Sant Pau
Barcelona
08026
Spain
Hospital Universitari Vall D Hebron
Barcelona
08035
Spain
Hospital Duran i Reynals
L'Hospitalet de Llobregat
08907
Spain
Hospital General Universitario Gregorio Marañón
Madrid
28007
Spain
Fundación Jiménez Díaz
Madrid
28040
Spain
Hospital Universitario La Paz
Madrid
28046
Spain
Hospital Universitario HM Sanchinarro
Madrid
28050
Spain
Hospital Universitario Virgen de la Victoria
Málaga
29010
Spain
Hospital Clínico de Santiago
Santiago de Compostela
15706
Spain
Hospital Universitario Miguel Servet
Zaragoza
50009
Spain
Skånes universitetssjukhus
Lund
22185
Sweden
Karolinska Universitetssjukhuset Stockholm
Stockholm
17177
Sweden
National Taiwan University Hospital
Taipei
100
Taiwan
Taipei Veterans General Hospital
Taipei
11217
Taiwan
Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara
06200
Turkey (Türkiye)
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
Velindre Cancer Centre
Cardiff
CF14 2TL
United Kingdom
Churchill Hospital
Headington
OX3 9DS
United Kingdom
University College Hospital
London
NW1 2BU
United Kingdom
The Royal Marsden Hospital, Chelsea
London
SW3 6JJ
United Kingdom
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
FG002
Doxorubicin
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
FG00090 subjects
FG001148 subjects
FG002162 subjects
Doxorubicin Patients Who Crossed Over to Brigimadlin 30 mg q3w
FG0000 subjects
FG0010 subjects
FG0027 subjectsPatients who had a confirmed Progressive Disease after receiving doxorubicin and then cross-over to treatment with brigimadlin 30 mg q3w.
Doxorubicin Patients Who Crossed Over to Brigimadlin 45 mg q3w
FG0000 subjects
FG0010 subjects
FG00270 subjectsPatients who had a confirmed Progressive Disease after receiving doxorubicin and then cross-over to treatment with brigimadlin 45 mg q3w.
COMPLETED
FG0000 subjects
FG0010 subjects
FG00276 subjectsCompleted planned treatment period
NOT COMPLETED
FG00090 subjects
FG001148 subjects
FG00286 subjects
Type
Comment
Reasons
Not treated
FG0001 subjects
FG0011 subjects
FG0028 subjects
Death
FG0002 subjects
FG0010 subjects
FG0020 subjects
Other than listed
FG0003 subjects
FG0017 subjects
FG00210 subjects
Protocol deviation
FG0005 subjects
FG0016 subjects
FG0024 subjects
Technical problems
FG0000 subjects
FG0011 subjects
FG0020 subjects
Burden of trial procedures
FG0000 subjects
FG0011 subjects
FG0022 subjects
Clinical disease progression
FG0006 subjects
FG0016 subjects
FG00211 subjects
Objective disease progression
FG00044 subjects
FG00161 subjects
FG00242 subjects
Adverse Event
FG00011 subjects
FG00136 subjects
FG0029 subjects
On treatment at time of snapshot
FG00018 subjects
FG00129 subjects
FG0020 subjects
All patients randomized, regardless of whether they have received any trial medication or not.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Brigimadlin 30 mg q3w
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 30 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
BG001
Brigimadlin 45 mg q3w
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
BG002
Doxorubicin
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00090
BG001148
BG002162
BG003400
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00062.3± 11.7
BG00164.7± 9.8
BG00263.0± 11.7
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00035
BG00152
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0008
BG0016
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
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
Progression-free Survival (PFS)
Progression-free survival (PFS) based on blinded central independent review. For each patient, PFS was defined as the time interval from randomization until tumor progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (solely based on blinded central independent review) or death from any cause, whichever occurs first.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter. (Note: the appearance of one or more new lesions is also considered progression).
Randomised Set (RS): All patients randomized, regardless of whether they have received any trial medication or not.
Posted
Median
Inter-Quartile Range
Months
Up to 20.6 months.
ID
Title
Description
OG000
Brigimadlin 30 mg q3w
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 30 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
OG001
Brigimadlin 45 mg q3w
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
OG002
Doxorubicin
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
Units
Counts
Participants
OG00090
OG001148
OG002162
Title
Denominators
Categories
Title
Measurements
OG0008.18(2.96 to 16.66)
OG0018.38(3.94 to NA)Not evaluable: not enough events reached.
OG0027.16(2.63 to 11.33)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
The primary estimator for the hazard ratio is the median unbiased estimator. The confidence interval (CI) for the hazard ratio is calculated as a repeated CI. The p-value is obtained using a weighted inverse normal method combining one-sided p-values from two stages.
Regression, Cox
0.0956
Hazard Ratio (HR)
0.79
2-Sided
95
0.60
1.06
A hazard ratio value below 1 favors brigimadlin.
Other
Secondary
Objective Response (OR)
Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1 (based on blinded central independent review) from the date of randomization until disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Randomised Set (RS): All patients randomized, regardless of whether they have received any trial medication or not.
Posted
Count of Participants
Participants
Up to 20.6 months.
ID
Title
Description
OG000
Brigimadlin 30 mg q3w
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 30 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
OG001
Brigimadlin 45 mg q3w
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
OG002
Secondary
Duration of Objective Response (DOR)
Duration of objective response (DOR), defined as the time interval from first documented confirmed OR until disease progression or death among patients with confirmed OR (based on blinded central independent review), whichever occurs first.
All patients randomized who had an objective response.
Posted
Median
95% Confidence Interval
Months
Up to 20.6 months.
ID
Title
Description
OG000
Brigimadlin 30 mg q3w
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 30 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
OG001
Brigimadlin 45 mg q3w
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
OG002
Doxorubicin
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
Secondary
Disease Control (DC)
Disease control (DC), defined as a best overall response of CR, PR, or stable disease (SD) according to RECIST version 1.1 (based on blinded central independent review).
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Randomised Set (RS): All patients randomized, regardless of whether they have received any trial medication or not.
Posted
Count of Participants
Participants
Up to 20.6 months.
ID
Title
Description
OG000
Brigimadlin 30 mg q3w
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 30 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
OG001
Brigimadlin 45 mg q3w
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
OG002
Doxorubicin
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
Secondary
Change in Health-Related Quality of Life at Week 6 and 18
Mean change from baseline to week 6 and 18 in the following European Organization for Research and Treatment on Cancer (EORTC) Quality of Life Core Questionnaire 30 items (QLQ-C30) scores:
Physical functioning (higher score is better)
Pain (higher score is worse)
Fatigue (higher score is worse)
Global health status / QoL (higher score is better)
and the following scores obtained using items from the EORTC QLQ-C30 and EORTC Item Library (higher score is worse):
Fatigue symptoms
Fatigability
Fatigue impact
Pain descriptors
Pain impact
All of the scales and single-item measures range in score from 0 to 100.
Randomised Set (RS). As per protocol, the endpoint was performed as part of the Phase III of the trial, which only includes the selected investigational arm (brigimadlin 45 mg q3w) and the doxorubicin control arm.
Posted
Mean
Standard Deviation
Score on a scale
Baseline (cycle 1 day 1), week 6 and week 18.
ID
Title
Description
OG000
Brigimadlin 45 mg q3w
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
OG001
Doxorubicin
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
Time Frame
Up to approximately 20.8 months.
Description
This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
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
Brigimadlin 30 mg q3w
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 30 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
31
89
27
89
89
89
EG001
Brigimadlin 45 mg q3w
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
40
147
57
147
144
147
EG002
Doxorubicin
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
15
154
42
154
153
154
EG003
Doxorubicin - Brigimadlin 30 mg q3w
Patients on Doxorubicin with a confirmed disease progression who crossed to Brigimadlin 30 mg taken orally on day 1 of each 21-day cycle (q3w).
5
7
1
7
6
7
EG004
Doxorubicin - Brigimadlin 45 mg q3w
Patients on Doxorubicin with a confirmed disease progression who crossed to Brigimadlin 45 mg taken orally on day 1 of each 21-day cycle (q3w).
22
70
22
70
67
70
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0017 affected147 at risk
EG0022 affected154 at risk
EG0030 affected7 at risk
EG0043 affected70 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected89 at risk
EG0011 affected147 at risk
EG00212 affected154 at risk
EG003
Myelosuppression
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0012 affected147 at risk
EG0022 affected154 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0016 affected147 at risk
EG0022 affected154 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0021 affected154 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Tachyarrhythmia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Duodenal stenosis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Gastric perforation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0021 affected154 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0011 affected147 at risk
EG0021 affected154 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Mesenteric vein thrombosis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected89 at risk
EG0012 affected147 at risk
EG0020 affected154 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Small intestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Condition aggravated
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Disease progression
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0012 affected147 at risk
EG0020 affected154 at risk
EG003
General physical health deterioration
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Hyperthermia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Infusion site phlebitis
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Malaise
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0012 affected147 at risk
EG0024 affected154 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Liver injury
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0022 affected154 at risk
EG003
Cytomegalovirus viraemia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Device related infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Focal peritonitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Fungaemia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Phlebitis infective
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Pneumocystis jirovecii infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0013 affected147 at risk
EG0022 affected154 at risk
EG003
Pneumonia necrotising
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0012 affected147 at risk
EG0020 affected154 at risk
EG003
Stoma site infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0002 affected89 at risk
EG0011 affected147 at risk
EG0021 affected154 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0015 affected147 at risk
EG0024 affected154 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG00112 affected147 at risk
EG0022 affected154 at risk
EG003
Troponin I increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0023 affected154 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Tumour fistulisation
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0012 affected147 at risk
EG0020 affected154 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Hypoglycaemic seizure
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Seizure
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0012 affected147 at risk
EG0020 affected154 at risk
EG003
Device physical property issue
Product Issues
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Obstructive nephropathy
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0011 affected147 at risk
EG0021 affected154 at risk
EG003
Renal vein embolism
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Ovarian vein thrombosis
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0022 affected154 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Pulmonary artery thrombosis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0003 affected89 at risk
EG0017 affected147 at risk
EG0027 affected154 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Assisted suicide
Surgical and medical procedures
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Aortic thrombosis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0012 affected147 at risk
EG0020 affected154 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected89 at risk
EG0013 affected147 at risk
EG0022 affected154 at risk
EG003
Embolism
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0014 affected147 at risk
EG0021 affected154 at risk
EG003
Embolism arterial
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Haematoma
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Iliac artery occlusion
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0021 affected154 at risk
EG003
Pelvic venous thrombosis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Peripheral artery occlusion
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Peripheral embolism
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Superficial vein thrombosis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Vasculitis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG00022 affected89 at risk
EG00152 affected147 at risk
EG00263 affected154 at risk
EG0031 affected7 at risk
EG00422 affected70 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected89 at risk
EG00115 affected147 at risk
EG00221 affected154 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected89 at risk
EG0014 affected147 at risk
EG0026 affected154 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG00016 affected89 at risk
EG00142 affected147 at risk
EG00249 affected154 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG00020 affected89 at risk
EG00140 affected147 at risk
EG00210 affected154 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0014 affected147 at risk
EG0022 affected154 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Visual impairment
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0005 affected89 at risk
EG0017 affected147 at risk
EG0023 affected154 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG00018 affected89 at risk
EG00128 affected147 at risk
EG00218 affected154 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG00010 affected89 at risk
EG0017 affected147 at risk
EG0029 affected154 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG00020 affected89 at risk
EG00126 affected147 at risk
EG00237 affected154 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG00035 affected89 at risk
EG00160 affected147 at risk
EG00242 affected154 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0003 affected89 at risk
EG0018 affected147 at risk
EG0023 affected154 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG00012 affected89 at risk
EG0018 affected147 at risk
EG00211 affected154 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0003 affected89 at risk
EG0018 affected147 at risk
EG0026 affected154 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG00071 affected89 at risk
EG001112 affected147 at risk
EG00290 affected154 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected89 at risk
EG0017 affected147 at risk
EG00233 affected154 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG00047 affected89 at risk
EG00155 affected147 at risk
EG00228 affected154 at risk
EG003
Asthenia
General disorders
MedDRA 27.0
Systematic Assessment
EG00029 affected89 at risk
EG00132 affected147 at risk
EG00240 affected154 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG00030 affected89 at risk
EG00165 affected147 at risk
EG00256 affected154 at risk
EG003
Influenza like illness
General disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected89 at risk
EG0015 affected147 at risk
EG0022 affected154 at risk
EG003
Malaise
General disorders
MedDRA 27.0
Systematic Assessment
EG0007 affected89 at risk
EG00114 affected147 at risk
EG00212 affected154 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected89 at risk
EG0017 affected147 at risk
EG00222 affected154 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.0
Systematic Assessment
EG00011 affected89 at risk
EG00114 affected147 at risk
EG00211 affected154 at risk
EG003
Pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0006 affected89 at risk
EG0016 affected147 at risk
EG0023 affected154 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG00011 affected89 at risk
EG0019 affected147 at risk
EG00221 affected154 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG00011 affected89 at risk
EG0018 affected147 at risk
EG0027 affected154 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0008 affected89 at risk
EG0015 affected147 at risk
EG0023 affected154 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0003 affected89 at risk
EG0015 affected147 at risk
EG0027 affected154 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0008 affected89 at risk
EG00112 affected147 at risk
EG0026 affected154 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0005 affected89 at risk
EG0019 affected147 at risk
EG0027 affected154 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0004 affected89 at risk
EG0012 affected147 at risk
EG0023 affected154 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0002 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0003 affected89 at risk
EG00112 affected147 at risk
EG0025 affected154 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0005 affected89 at risk
EG00113 affected147 at risk
EG0025 affected154 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG00025 affected89 at risk
EG00148 affected147 at risk
EG00231 affected154 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG00025 affected89 at risk
EG00143 affected147 at risk
EG00213 affected154 at risk
EG003
Weight decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0005 affected89 at risk
EG00116 affected147 at risk
EG00210 affected154 at risk
EG003
Weight increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0003 affected89 at risk
EG0015 affected147 at risk
EG0022 affected154 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG00016 affected89 at risk
EG00120 affected147 at risk
EG00221 affected154 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG00035 affected89 at risk
EG00168 affected147 at risk
EG00241 affected154 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0004 affected89 at risk
EG0019 affected147 at risk
EG00211 affected154 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0004 affected89 at risk
EG0013 affected147 at risk
EG0025 affected154 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0003 affected89 at risk
EG0019 affected147 at risk
EG00211 affected154 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0012 affected147 at risk
EG0025 affected154 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0004 affected89 at risk
EG00110 affected147 at risk
EG0027 affected154 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0012 affected147 at risk
EG0025 affected154 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0009 affected89 at risk
EG00117 affected147 at risk
EG0029 affected154 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG00010 affected89 at risk
EG00113 affected147 at risk
EG00212 affected154 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected147 at risk
EG0020 affected154 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0003 affected89 at risk
EG0018 affected147 at risk
EG0026 affected154 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG00012 affected89 at risk
EG00111 affected147 at risk
EG00210 affected154 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG00019 affected89 at risk
EG00140 affected147 at risk
EG00226 affected154 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0007 affected89 at risk
EG00115 affected147 at risk
EG00215 affected154 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0004 affected89 at risk
EG0015 affected147 at risk
EG0022 affected154 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected89 at risk
EG0011 affected147 at risk
EG0020 affected154 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0007 affected89 at risk
EG00119 affected147 at risk
EG0025 affected154 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected89 at risk
EG0014 affected147 at risk
EG0021 affected154 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG00015 affected89 at risk
EG00120 affected147 at risk
EG0029 affected154 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0009 affected89 at risk
EG00115 affected147 at risk
EG0026 affected154 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0004 affected89 at risk
EG00119 affected147 at risk
EG0028 affected154 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG00012 affected89 at risk
EG00132 affected147 at risk
EG00267 affected154 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0003 affected89 at risk
EG00112 affected147 at risk
EG0026 affected154 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
Units
Counts
Participants
OG00090
OG001148
OG002162
Title
Denominators
Categories
Title
Measurements
OG00013
OG00133
OG00214
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
The primary estimator and CI for the odds ratio is by Cochran-Mantel-Haenszel.
Odds Ratio (OR)
2.93
2-Sided
95
1.52
5.67
An odds ratio value greater than 1 favors brigimadlin.
Other
Units
Counts
Participants
OG00013
OG00133
OG00214
Title
Denominators
Categories
Title
Measurements
OG000NA(8.51 to NA)Not enough participants with events.
OG0019.92(9.72 to NA)Not enough participants with events.
OG0029.99(9.89 to 15.41)
Units
Counts
Participants
OG00090
OG001148
OG002162
Title
Denominators
Categories
Title
Measurements
OG00071
OG001128
OG002117
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Odds ratios are calculated from a logistic regression model with the stratification factor (locally advanced vs. metastatic) included as a covariate.
Odds Ratio (OR)
1.51
2-Sided
95
0.81
2.82
An odds ratio value greater than 1 favors brigimadlin.
Other
OG001
OG002
Odds ratios are calculated from a logistic regression model with the stratification factor (locally advanced vs. metastatic) included as a covariate. Exact 95% confidence interval (CI) by Clopper and Pearson.
Odds Ratio (OR)
2.67
2-Sided
95
1.48
4.84
An odds ratio value greater than 1 favors brigimadlin.
Other
Units
Counts
Participants
OG000121
OG001114
Title
Denominators
Categories
Physical functioning - Change from baseline at Week 6
ParticipantsOG00094
ParticipantsOG00185
Title
Measurements
OG000-2.1± 17.4
OG001-5.5± 17.9
Physical functioning - Change from baseline at Week 18
ParticipantsOG00069
ParticipantsOG00149
Title
Measurements
OG000-5.9± 20.8
OG001
Pain - Change from baseline at Week 6
ParticipantsOG00094
ParticipantsOG00185
Title
Measurements
OG000-3.7± 20.2
OG001
Pain - Change from baseline at Week 18
ParticipantsOG00069
ParticipantsOG00149
Title
Measurements
OG0001.4± 26.0
OG001
Fatigue - Change from baseline at Week 6
ParticipantsOG00094
ParticipantsOG00185
Title
Measurements
OG0003.4± 21.2
OG001
Fatigue - Change from baseline at Week 18
ParticipantsOG00069
ParticipantsOG00149
Title
Measurements
OG0008.1± 27.5
OG001
Global health status / quality of life - Change from baseline at Week 6
ParticipantsOG00094
ParticipantsOG00185
Title
Measurements
OG000-0.6± 18.6
OG001
Global health status / quality of life - Change from baseline at Week 18
ParticipantsOG00069
ParticipantsOG00149
Title
Measurements
OG000-5.8± 24.5
OG001
Fatigue symptoms - Change from baseline at Week 6
ParticipantsOG000100
ParticipantsOG00190
Title
Measurements
OG0003.4± 19.2
OG001
Fatigue symptoms - Change from baseline at Week 18
ParticipantsOG00075
ParticipantsOG00152
Title
Measurements
OG0007.9± 26.7
OG001
Fatigability - Change from baseline at Week 6
ParticipantsOG000100
ParticipantsOG00190
Title
Measurements
OG0003.3± 19.8
OG001
Fatigability - Change from baseline at Week 18
ParticipantsOG00075
ParticipantsOG00152
Title
Measurements
OG0005.1± 23.3
OG001
Fatigue impact - Change from baseline at Week 6
ParticipantsOG000100
ParticipantsOG00190
Title
Measurements
OG000-1.5± 20.5
OG001
Fatigue impact - Change from baseline at Week 18
ParticipantsOG00075
ParticipantsOG00152
Title
Measurements
OG0001.6± 23.5
OG001
Pain descriptors - Change from baseline at Week 6
ParticipantsOG00096
ParticipantsOG00185
Title
Measurements
OG000-2.7± 18.5
OG001
Pain descriptors - Change from baseline at Week 18