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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003707-19 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M7824 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M7824 | Drug | Participants received an intravenous infusion of 1200 milligrams (mg) M7824 once every 2 weeks until confirmed disease progression, death, unacceptable toxicity or study withdrawal. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC. | Time from first treatment up to 555 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | DOR was defined for participants with confirmed response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC. Results were calculated based on Kaplan-Meier estimates. |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | United States | ||
| UCSF Mount Zion Medical Ctr |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32461347 | Result | Yoo C, Oh DY, Choi HJ, Kudo M, Ueno M, Kondo S, Chen LT, Osada M, Helwig C, Dussault I, Ikeda M. Phase I study of bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1, in patients with pretreated biliary tract cancer. J Immunother Cancer. 2020 May;8(1):e000564. doi: 10.1136/jitc-2020-000564. | |
| 38087967 | Derived |
| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
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We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
First participant signed informed consent: 26 Mar 2019, Clinical cutoff date: 30 March 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | M7824 | Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 22, 2021 | Oct 29, 2021 |
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| Time from first documentation of objective response to data cutoff (assessed up to 736 days) |
| Durable Response Rate (DRR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | DRR was defined as the percentage of participants with confirmed objective response (CR or PR) with duration of at least 6 months. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DRR was determined according to RECIST v1.1 and assessed by IRC. | Time from first treatment to data cutoff (assessed up to 736 days) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs) | Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious AEs and non-serious AEs. Treatment-related TEAEs: reasonably related to the study intervention. AESIs included Infusion-related reactions, Immune-related AEs, Transforming growth factor-beta (TGF-β) inhibition mediated skin AE and anemia. | Time from first treatment to data cutoff (assessed up to 736 days) |
| Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) | PFS was defined as the time from first administration of study intervention until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study drug until the first documentation of PD or death, assessed up to data-cutoff (736 days) |
| Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator | Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by Investigator. | Time from first treatment to data cutoff (assessed up to 736 days) |
| Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator | DOR was defined for participants with confirmed response, as the time from first documentation of objective response (Complete Response [CR] or Partial Rresponse [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and assessed by Investigator. Results were calculated based on Kaplan-Meier estimates. | Time from first documentation of objective response to data cutoff (assessed up to 736 days) |
| Durable Response Rate (DRR) Acoording to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator | DRR was defined as the percentage of participants with confirmed objective response (CR or PR) with duration of at least 6 months. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DRR was determined according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and assessed by Investigator. | Time from first treatment to data cutoff (assessed up to 736 days) |
| Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator | PFS was defined as the time from first administration of study intervention until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study drug until the first documentation of PD or death, assessed up to data-cutoff (736 days) |
| Overall Survival (OS) | OS was defined as the time from first administration of study intervention to the date of death due to any cause. The OS was analyzed by using the Kaplan-Meier method. | Time from first administration of study drug to data cutoff (assessed up to 736 days) |
| Serum Pre-Dose Concentrations (Ctrough) of M7824 | Ctrough was defined as the concentration observed immediately before next dosing (corresponding to pre-dose or trough concentration for multiple dosing). | At Day 15, Day 29, Day 43, Day 85, Day 127, Day 169, Day 253, Day 337, Day 421 and Day 505 |
| Serum Concentration at End of Infusion (CEOI) of M7824 | Serum Concentration at End of Infusion (CEOI) of M7824 is reported. | At Day 1 and Day 29 |
| Number of Participants With Positive Antidrug Antibodies (ADA) | Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported. | Time from first treatment to data cutoff (assessed up to 736 days) |
| Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression | Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC through PD-L1 Subgroup: PD-L1 expression on tumor cells (TC) and on immune cells (IC) at baseline and in the following categories: <1%, >=1%, <5%, >=5%, <25%, >=25%, <50%, >=50% were reported. | Time from first treatment to data cutoff (assessed up to 736 days) |
| Percentage of Participants With Confirmed Objective Response as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) According to Microsatellite Instability (MSI) Status | Confirmed OR was defined as the percentage of participants with a confirmed OR of CR or PR. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed OR was determined according to RECIST v1.1 and as adjudicated by IRC through MSI Status subgroups as:- MSI High = if participant is MSI High for any (at least one) test;- Microsatellite stable (MSS) or MSI Low = if participant is not MSI High for any test;- Unknown (missing) = no MSI tests available at baseline was reported. MSI high: if 2 or more unstable markers were detected in sample; MSI low: if 1 marker was unstable and remaining markers were stable and MSS if all markers were stable. | Time from first treatment to data cutoff (assessed up to 736 days) |
| Duration of Response (DOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression | DOR was defined for participants with confirmed response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and as adjudicated by IRC through PD-L1 Subgroup: PD-L1 expression on tumor cells (TC) and on immune cells (IC) at baseline and in the following categories: <1%, >=1%, <5%, >=5%, <25%, >=25%, <50%, >=50% was reported. | Time from first documentation of objective response to data cutoff (assessed up to 736 days) |
| Duration of Response (DOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to According to Microsatellite Instability (MSI) Status | DOR was defined for participants with confirmed response, as the time from first documentation of objective response (CR) or (PR) to the date of first documentation of PD or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and as adjudicated by IRC through MSI Status subgroups as:- MSI High = if participant is MSI High for any (at least one) test;- MSS or MSI Low = if participant is not MSI High for any test;- Unknown (missing) = no MSI tests available at baseline was reported. MSI high: if 2 or more unstable markers were detected in sample; MSI low: if 1 marker was unstable and remaining markers were stable and MSS if all markers were stable. | Time from first documentation of objective response to data cutoff (assessed up to 736 days) |
| Durable Response Rate (DRR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression | DRR was defined as the percentage of participants with confirmed objective response (CR or PR) with duration of at least 6 months. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DRR was determined according to RECIST v1.1 and adjudicated by IRC through PD-L1 Subgroup: PD-L1 expression on tumor cells (TC) and on immune cells (IC) at baseline and in the following categories: <1%, >=1%, <5%, >=5%, <25%, >=25%, <50%, >=50% was reported. | Time from first treatment to data cutoff (assessed up to 736 days) |
| Durable Response Rate (DRR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to According to Microsatellite Instability (MSI) Status | DRR was defined as the percentage of participants with confirmed OR (CR or PR) with duration of at least 6 months. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DRR was determined according to RECIST v1.1 and adjudicated by IRC through MSI Status subgroups as:- MSI High = if participant is MSI High for any (at least one) test;- MSS or MSI Low = if participant is not MSI High for any test;- Unknown (missing) = no MSI tests available at baseline was reported. MSI high: if 2 or more unstable markers were detected in sample; MSI low: if 1 marker was unstable and remaining markers were stable and MSS if all markers were stable. | Time from first treatment to data cutoff (assessed up to 736 days) |
| San Francisco |
| California |
| 94158 |
| United States |
| Mayo Clinic in Florida - Department of Neurology | Jacksonville | Florida | 32224 | United States |
| H. Lee Moffitt Cancer Center and Research Institute, Inc | Tampa | Florida | 33612-9497 | United States |
| Sidney Kimmel Comprehensive Cancer Center at John Hopkins | Baltimore | Maryland | 21231 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| MD Anderson Cancer Center - Unit | Houston | Texas | 77030 | United States |
| Peking University Cancer Hospital | Beijing | 100142 | China |
| Affiliated Tumor Hospital of Harbin Medical University | Harbin | 150081 | China |
| Groupe Hospitalier Sud - Hôpital Haut Lévêque - Service Hepato Gastroentérologie Oncologie Digest | Pessac | 33604 | France |
| ICO - Site René Gauducheau | Saint-Herblain | 44805 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Unita' Operativa di Pediatria | Bologna | 40138 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori Milano | Milan | 20133 | Italy |
| Policlinico Universitario Agostino Gemelli - UOC Oncologia Medica | Roma | 00168 | Italy |
| National Cancer Center Hospital - Dept of Hepatobiliary and Pancreatic Oncology | Chūōku | 104-0045 | Japan |
| National Cancer Center Hospital East | Kashiwa-shi | 277-8577 | Japan |
| Kyorin University Hospital - Dept of Oncology | Mitaka-shi | 181-8611 | Japan |
| Kindai University Hospital - Dept of Gastroenterology | Osakasayama-shi | 589-8511 | Japan |
| Kanagawa Cancer Center | Yokohama | 241-8515 | Japan |
| Seoul National University Bundang Hospital | Seongnam-si | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08027 | Spain |
| Hospital Universitari Vall d'Hebron - Dept of Oncology | Barcelona | 8035 | Spain |
| Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia | Madrid | 28050 | Spain |
| Chang Gung Memorial Hospital, Linkou | Linkou District | 333 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| St James's University Hospital - Dept of Oncology | Leeds | LS9 7TF | United Kingdom |
| Milenkovic-Grisic AM, Terranova N, Mould DR, Vugmeyster Y, Mrowiec T, Machl A, Girard P, Venkatakrishnan K, Khandelwal A. Tumor growth inhibition modeling in patients with second line biliary tract cancer and first line non-small cell lung cancer based on bintrafusp alfa trials. CPT Pharmacometrics Syst Pharmacol. 2024 Jan;13(1):143-153. doi: 10.1002/psp4.13068. Epub 2023 Dec 13. |
| 36999533 | Derived | Yoo C, Javle MM, Verdaguer Mata H, de Braud F, Trojan J, Raoul JL, Kim JW, Ueno M, Lee CK, Hijioka S, Cubillo A, Furuse J, Azad N, Sato M, Vugmeyster Y, Machl A, Bajars M, Bridgewater J, Oh DY, Borad MJ. Phase 2 trial of bintrafusp alfa as second-line therapy for patients with locally advanced/metastatic biliary tract cancers. Hepatology. 2023 Sep 1;78(3):758-770. doi: 10.1097/HEP.0000000000000365. Epub 2023 Apr 1. |
| US Medical Information website, Medical Resources | View source |
| COMPLETED |
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| NOT COMPLETED |
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The Intention-To-Treat (ITT) analysis set included all participants who were administered at least one dose of M7824.
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| ID | Title | Description |
|---|---|---|
| BG000 | M7824 | Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC. | ITT analysis set included all participants who were administered at least one dose of M7824. | Posted | Number | 95% Confidence Interval | percentage of participants | Time from first treatment up to 555 days |
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| Secondary | Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | DOR was defined for participants with confirmed response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC. Results were calculated based on Kaplan-Meier estimates. | ITT analysis set included all participants who were administered at least one dose of M7824. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Time from first documentation of objective response to data cutoff (assessed up to 736 days) |
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| Secondary | Durable Response Rate (DRR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | DRR was defined as the percentage of participants with confirmed objective response (CR or PR) with duration of at least 6 months. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DRR was determined according to RECIST v1.1 and assessed by IRC. | ITT analysis set included all participants who were administered at least one dose of M7824. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Time from first treatment to data cutoff (assessed up to 736 days) |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs) | Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious AEs and non-serious AEs. Treatment-related TEAEs: reasonably related to the study intervention. AESIs included Infusion-related reactions, Immune-related AEs, Transforming growth factor-beta (TGF-β) inhibition mediated skin AE and anemia. | Safety analysis set included all participants who were administered at least one dose of M7824. | Posted | Count of Participants | Participants | Time from first treatment to data cutoff (assessed up to 736 days) |
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| Secondary | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) | PFS was defined as the time from first administration of study intervention until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | ITT analysis set included all participants who were administered at least one dose of M7824. | Posted | Median | 95% Confidence Interval | months | Time from first administration of study drug until the first documentation of PD or death, assessed up to data-cutoff (736 days) |
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| Secondary | Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator | Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by Investigator. | ITT analysis set included all participants who were administered at least one dose of M7824. | Posted | Number | 95% Confidence Interval | percentage of participants | Time from first treatment to data cutoff (assessed up to 736 days) |
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| Secondary | Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator | DOR was defined for participants with confirmed response, as the time from first documentation of objective response (Complete Response [CR] or Partial Rresponse [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and assessed by Investigator. Results were calculated based on Kaplan-Meier estimates. | ITT analysis set included all participants who were administered at least one dose of M7824. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Time from first documentation of objective response to data cutoff (assessed up to 736 days) |
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| Secondary | Durable Response Rate (DRR) Acoording to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator | DRR was defined as the percentage of participants with confirmed objective response (CR or PR) with duration of at least 6 months. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DRR was determined according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and assessed by Investigator. | ITT analysis set included all participants who were administered at least one dose of M7824. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Time from first treatment to data cutoff (assessed up to 736 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator | PFS was defined as the time from first administration of study intervention until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | ITT analysis set included all participants who were administered at least one dose of M7824. | Posted | Median | 95% Confidence Interval | months | Time from first administration of study drug until the first documentation of PD or death, assessed up to data-cutoff (736 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from first administration of study intervention to the date of death due to any cause. The OS was analyzed by using the Kaplan-Meier method. | ITT analysis set included all participants who were administered at least one dose of M7824. | Posted | Median | 95% Confidence Interval | months | Time from first administration of study drug to data cutoff (assessed up to 736 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Serum Pre-Dose Concentrations (Ctrough) of M7824 | Ctrough was defined as the concentration observed immediately before next dosing (corresponding to pre-dose or trough concentration for multiple dosing). | Pharmacokinetic (PK) analysis set included all participants who completed at least one dose of M7824 and who provided at least one sample with a measurable concentration of M7824. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified time points for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (mcg/mL) | At Day 15, Day 29, Day 43, Day 85, Day 127, Day 169, Day 253, Day 337, Day 421 and Day 505 |
|
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| Secondary | Serum Concentration at End of Infusion (CEOI) of M7824 | Serum Concentration at End of Infusion (CEOI) of M7824 is reported. | PK analysis set included all participants who completed at least one dose of M7824 and who provided at least one sample with a measurable concentration of M7824. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified time points for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | At Day 1 and Day 29 |
|
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| Secondary | Number of Participants With Positive Antidrug Antibodies (ADA) | Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported. | Immunogenicity analysis set included all participants who received at least one dose of M7824 and who had at least one valid result of ADA. | Posted | Count of Participants | Participants | Time from first treatment to data cutoff (assessed up to 736 days) |
|
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| Secondary | Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression | Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC through PD-L1 Subgroup: PD-L1 expression on tumor cells (TC) and on immune cells (IC) at baseline and in the following categories: <1%, >=1%, <5%, >=5%, <25%, >=25%, <50%, >=50% were reported. | ITT analysis set included all participants who were administered at least one dose of M7824. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable for the specified categories for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Time from first treatment to data cutoff (assessed up to 736 days) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Confirmed Objective Response as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) According to Microsatellite Instability (MSI) Status | Confirmed OR was defined as the percentage of participants with a confirmed OR of CR or PR. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed OR was determined according to RECIST v1.1 and as adjudicated by IRC through MSI Status subgroups as:- MSI High = if participant is MSI High for any (at least one) test;- Microsatellite stable (MSS) or MSI Low = if participant is not MSI High for any test;- Unknown (missing) = no MSI tests available at baseline was reported. MSI high: if 2 or more unstable markers were detected in sample; MSI low: if 1 marker was unstable and remaining markers were stable and MSS if all markers were stable. | ITT analysis set included all participants who were administered at least one dose of M7824. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable for the specified categories for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Time from first treatment to data cutoff (assessed up to 736 days) |
| |||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression | DOR was defined for participants with confirmed response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and as adjudicated by IRC through PD-L1 Subgroup: PD-L1 expression on tumor cells (TC) and on immune cells (IC) at baseline and in the following categories: <1%, >=1%, <5%, >=5%, <25%, >=25%, <50%, >=50% was reported. | ITT analysis set included all participants who were administered at least one dose of M7824. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable for the specified categories for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Time from first documentation of objective response to data cutoff (assessed up to 736 days) |
| |||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to According to Microsatellite Instability (MSI) Status | DOR was defined for participants with confirmed response, as the time from first documentation of objective response (CR) or (PR) to the date of first documentation of PD or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and as adjudicated by IRC through MSI Status subgroups as:- MSI High = if participant is MSI High for any (at least one) test;- MSS or MSI Low = if participant is not MSI High for any test;- Unknown (missing) = no MSI tests available at baseline was reported. MSI high: if 2 or more unstable markers were detected in sample; MSI low: if 1 marker was unstable and remaining markers were stable and MSS if all markers were stable. | ITT analysis set included all participants who were administered at least one dose of M7824. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable for the specified categories for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Time from first documentation of objective response to data cutoff (assessed up to 736 days) |
| |||||||||||||||||||||||||||
| Secondary | Durable Response Rate (DRR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression | DRR was defined as the percentage of participants with confirmed objective response (CR or PR) with duration of at least 6 months. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DRR was determined according to RECIST v1.1 and adjudicated by IRC through PD-L1 Subgroup: PD-L1 expression on tumor cells (TC) and on immune cells (IC) at baseline and in the following categories: <1%, >=1%, <5%, >=5%, <25%, >=25%, <50%, >=50% was reported. | ITT analysis set included all participants who were administered at least one dose of M7824. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable for the specified categories for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Time from first treatment to data cutoff (assessed up to 736 days) |
| |||||||||||||||||||||||||||
| Secondary | Durable Response Rate (DRR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to According to Microsatellite Instability (MSI) Status | DRR was defined as the percentage of participants with confirmed OR (CR or PR) with duration of at least 6 months. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DRR was determined according to RECIST v1.1 and adjudicated by IRC through MSI Status subgroups as:- MSI High = if participant is MSI High for any (at least one) test;- MSS or MSI Low = if participant is not MSI High for any test;- Unknown (missing) = no MSI tests available at baseline was reported. MSI high: if 2 or more unstable markers were detected in sample; MSI low: if 1 marker was unstable and remaining markers were stable and MSS if all markers were stable. | ITT analysis set included all participants who were administered at least one dose of M7824. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable for the specified categories for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Time from first treatment to data cutoff (assessed up to 736 days) |
|
Time from first treatment to data cutoff (assessed up to 736 days)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | M7824 | Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal. | 108 | 159 | 86 | 159 | 144 | 159 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Duodenal stenosis | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Gastric stenosis | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Gastrointestinal vascular malformation haemorrhagic | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Infective spondylitis | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Varicella zoster pneumonia | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Latent autoimmune diabetes in adults | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Tumour hyperprogression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Tumour necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Immune-mediated encephalitis | Nervous system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Lichenoid keratosis | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Biliary stent placement | Surgical and medical procedures | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Anaemia of malignant disease | Blood and lymphatic system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hypercalcaemia of malignancy | Endocrine disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Angular cheilitis | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Portal hypertensive gastropathy | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Mucosal haemorrhage | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Infusion related hypersensitivity reaction | Immune system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Candida infections | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Herpes oesophagitis | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pyuria | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Blood albumin increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Cell marker increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Steroid diabetes | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Muscle discomfort | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Sarcopenia | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Lip squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Visual field defect | Nervous system disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Nipple pain | Reproductive system and breast disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pruritus genital | Reproductive system and breast disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Scrotal oedema | Reproductive system and breast disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Acanthosis nigricans | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Keratosis pilaris | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Lichenoid keratosis | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Milia | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Scab | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA version 23.1 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA version 23.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 26, 2020 | Oct 29, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D018281 | Cholangiocarcinoma |
| D005706 | Gallbladder Neoplasms |
| D003966 | Camurati-Engelmann Syndrome |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D005705 | Gallbladder Diseases |
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C000723824 | bintrafusp alfa protein, human |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
|
|
|
Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|