Fatal events during clinical trials: an evaluation of deaths during breast cancer studies
Background Information on deaths occurring during oncological clinical trials has never been systematically assessed. Here, we examine the incidence of death and the profile of patients who died during randomized clinical breast cancer (BC) trials. Methods Information on fatal events during German B...
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| Veröffentlicht in: | Breast cancer (Tokyo, Japan) Japan), 2019-11, Vol.26 (6), p.826-834 |
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| creator | Furlanetto, Jenny von Minckwitz, Gunter Lederer, Bianca Möbus, Volker Schneeweiss, Andreas Huober, Jens Fasching, Peter A. Gerber, Bernd Bauerfeind, Ingo Nitz, Ulrike Lück, Hans-Joachim Hanusch, Claus Thomssen, Christoph Untch, Michael Nekljudova, Valentina Mehta, Keyur Loibl, Sibylle |
| description | Background
Information on deaths occurring during oncological clinical trials has never been systematically assessed. Here, we examine the incidence of death and the profile of patients who died during randomized clinical breast cancer (BC) trials.
Methods
Information on fatal events during German Breast Group (GBG) led BC trials was prospectively captured. Data were derived from the trial databases and death narratives. All deaths were evaluated for possible causes, underlying conditions, treatment relatedness, time point and rate of autopsies.
Results
From 12/1996 to 01/2017, 23,387 patients were treated within 32 trials. Of those 88 (0.4%) died on therapy within 17 trials. Median age was 64 [range 35–84] years, 63.2% of patients had a body mass index (BMI) ≥ 25 kg/m
2
; 65.9% 1–3 and 22.7% ≥ 4 comorbidities; 61.4% 1–2 cardiovascular risk factors (CRFs); 26.4% took > 3 drugs; 81.7% had ECOG 0; 50.0% stage III, 76.7% luminal BC. The main causes of death were infection (38.6%; of those, 82.3% sepsis, 17.6% pneumonia), heart failure (14.8%), and pulmonary embolism (13.6%). Fatal events mainly occurred within the first 4 therapy cycles (55.7%), in the investigational arm (66.7%) and under anthracycline–taxane-based chemotherapy (51.1%). A relationship with the treatment was declared in 27.3% of the cases. An autopsy was performed in 13.6% of patients.
Conclusions
Death during study treatment was mainly related to infections, and patients with advanced disease, high BMI, underlying comorbidities, CRFs and concomitant medications. If considered for study participation these patients need careful monitoring due to their higher risk for death on study. |
| doi_str_mv | 10.1007/s12282-019-00990-3 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_miscellaneous_2250613838</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A712280523</galeid><sourcerecordid>A712280523</sourcerecordid><originalsourceid>FETCH-LOGICAL-c389t-bb0bd670fbd85adca33d2a3bf5e75c3fd5141dbd90f8f925686e9362b138316f3</originalsourceid><addsrcrecordid>eNp9kc1LHjEQxoNUqr7tP-ChLPTSy-ok2Y9sbyK1CkIveugp5GOikX2zb5Os4H9vtqtCQcocMgy_Z5g8DyHHFE4oQH-aKGOC1UCHGmAYoOZ75JAKAXXDOP9Qet5A3YlOHJCjlB4AGt5D95EccMrahgE9JL8vVFZjhY8YcqrsHH24q8zogzdlnKNXY_peqVAINc4q-ylUk6ssqnz_xuuIKuXKqGAwVinP1mP6RPZdEePnl3dDbi9-3Jxf1te_fl6dn13Xhosh11qDtl0PTlvRKmsU55Yprl2LfWu4sy1tqNV2ACfcwNryHRx4xzTlgtPO8Q35tu7dxenPjCnLrU8Gx1EFnOYkGWuhW2BR0K8reqdGlD64KUdlFlye9YuZ0BbjNuTkHaqUxa03U0Dny_wfAVsFJk4pRXRyF_1WxSdJQS5JyTUpWZKSf5OSi-jLy9mz3qJ9k7xGUwC-Amm3mIxRPkxzDMXK_619BsgbnYI</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2250613838</pqid></control><display><type>article</type><title>Fatal events during clinical trials: an evaluation of deaths during breast cancer studies</title><source>MEDLINE</source><source>SpringerLink Journals</source><creator>Furlanetto, Jenny ; von Minckwitz, Gunter ; Lederer, Bianca ; Möbus, Volker ; Schneeweiss, Andreas ; Huober, Jens ; Fasching, Peter A. ; Gerber, Bernd ; Bauerfeind, Ingo ; Nitz, Ulrike ; Lück, Hans-Joachim ; Hanusch, Claus ; Thomssen, Christoph ; Untch, Michael ; Nekljudova, Valentina ; Mehta, Keyur ; Loibl, Sibylle</creator><creatorcontrib>Furlanetto, Jenny ; von Minckwitz, Gunter ; Lederer, Bianca ; Möbus, Volker ; Schneeweiss, Andreas ; Huober, Jens ; Fasching, Peter A. ; Gerber, Bernd ; Bauerfeind, Ingo ; Nitz, Ulrike ; Lück, Hans-Joachim ; Hanusch, Claus ; Thomssen, Christoph ; Untch, Michael ; Nekljudova, Valentina ; Mehta, Keyur ; Loibl, Sibylle</creatorcontrib><description>Background
Information on deaths occurring during oncological clinical trials has never been systematically assessed. Here, we examine the incidence of death and the profile of patients who died during randomized clinical breast cancer (BC) trials.
Methods
Information on fatal events during German Breast Group (GBG) led BC trials was prospectively captured. Data were derived from the trial databases and death narratives. All deaths were evaluated for possible causes, underlying conditions, treatment relatedness, time point and rate of autopsies.
Results
From 12/1996 to 01/2017, 23,387 patients were treated within 32 trials. Of those 88 (0.4%) died on therapy within 17 trials. Median age was 64 [range 35–84] years, 63.2% of patients had a body mass index (BMI) ≥ 25 kg/m
2
; 65.9% 1–3 and 22.7% ≥ 4 comorbidities; 61.4% 1–2 cardiovascular risk factors (CRFs); 26.4% took > 3 drugs; 81.7% had ECOG 0; 50.0% stage III, 76.7% luminal BC. The main causes of death were infection (38.6%; of those, 82.3% sepsis, 17.6% pneumonia), heart failure (14.8%), and pulmonary embolism (13.6%). Fatal events mainly occurred within the first 4 therapy cycles (55.7%), in the investigational arm (66.7%) and under anthracycline–taxane-based chemotherapy (51.1%). A relationship with the treatment was declared in 27.3% of the cases. An autopsy was performed in 13.6% of patients.
Conclusions
Death during study treatment was mainly related to infections, and patients with advanced disease, high BMI, underlying comorbidities, CRFs and concomitant medications. If considered for study participation these patients need careful monitoring due to their higher risk for death on study.</description><identifier>ISSN: 1340-6868</identifier><identifier>EISSN: 1880-4233</identifier><identifier>DOI: 10.1007/s12282-019-00990-3</identifier><identifier>PMID: 31254201</identifier><language>eng</language><publisher>Tokyo: Springer Japan</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Anthracyclines - adverse effects ; Anthracyclines - therapeutic use ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Autopsy ; Body Mass Index ; Breast cancer ; Breast Neoplasms - drug therapy ; Breast Neoplasms - mortality ; Breast Neoplasms - pathology ; Bridged-Ring Compounds - adverse effects ; Bridged-Ring Compounds - therapeutic use ; Cancer ; Cancer Research ; Chemotherapy ; Clinical trials ; Comorbidity ; Female ; Germany ; Heart Failure - complications ; Humans ; Medicine ; Medicine & Public Health ; Middle Aged ; Oncology ; Oncology, Experimental ; Original Article ; Patient Safety ; Pneumonia - complications ; Prospective Studies ; Pulmonary embolism ; Pulmonary Embolism - complications ; Randomized Controlled Trials as Topic ; Risk Factors ; Sepsis - complications ; Surgery ; Surgical Oncology ; Taxoids - adverse effects ; Taxoids - therapeutic use</subject><ispartof>Breast cancer (Tokyo, Japan), 2019-11, Vol.26 (6), p.826-834</ispartof><rights>The Japanese Breast Cancer Society 2019</rights><rights>COPYRIGHT 2019 Springer</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c389t-bb0bd670fbd85adca33d2a3bf5e75c3fd5141dbd90f8f925686e9362b138316f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s12282-019-00990-3$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12282-019-00990-3$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31254201$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Furlanetto, Jenny</creatorcontrib><creatorcontrib>von Minckwitz, Gunter</creatorcontrib><creatorcontrib>Lederer, Bianca</creatorcontrib><creatorcontrib>Möbus, Volker</creatorcontrib><creatorcontrib>Schneeweiss, Andreas</creatorcontrib><creatorcontrib>Huober, Jens</creatorcontrib><creatorcontrib>Fasching, Peter A.</creatorcontrib><creatorcontrib>Gerber, Bernd</creatorcontrib><creatorcontrib>Bauerfeind, Ingo</creatorcontrib><creatorcontrib>Nitz, Ulrike</creatorcontrib><creatorcontrib>Lück, Hans-Joachim</creatorcontrib><creatorcontrib>Hanusch, Claus</creatorcontrib><creatorcontrib>Thomssen, Christoph</creatorcontrib><creatorcontrib>Untch, Michael</creatorcontrib><creatorcontrib>Nekljudova, Valentina</creatorcontrib><creatorcontrib>Mehta, Keyur</creatorcontrib><creatorcontrib>Loibl, Sibylle</creatorcontrib><title>Fatal events during clinical trials: an evaluation of deaths during breast cancer studies</title><title>Breast cancer (Tokyo, Japan)</title><addtitle>Breast Cancer</addtitle><addtitle>Breast Cancer</addtitle><description>Background
Information on deaths occurring during oncological clinical trials has never been systematically assessed. Here, we examine the incidence of death and the profile of patients who died during randomized clinical breast cancer (BC) trials.
Methods
Information on fatal events during German Breast Group (GBG) led BC trials was prospectively captured. Data were derived from the trial databases and death narratives. All deaths were evaluated for possible causes, underlying conditions, treatment relatedness, time point and rate of autopsies.
Results
From 12/1996 to 01/2017, 23,387 patients were treated within 32 trials. Of those 88 (0.4%) died on therapy within 17 trials. Median age was 64 [range 35–84] years, 63.2% of patients had a body mass index (BMI) ≥ 25 kg/m
2
; 65.9% 1–3 and 22.7% ≥ 4 comorbidities; 61.4% 1–2 cardiovascular risk factors (CRFs); 26.4% took > 3 drugs; 81.7% had ECOG 0; 50.0% stage III, 76.7% luminal BC. The main causes of death were infection (38.6%; of those, 82.3% sepsis, 17.6% pneumonia), heart failure (14.8%), and pulmonary embolism (13.6%). Fatal events mainly occurred within the first 4 therapy cycles (55.7%), in the investigational arm (66.7%) and under anthracycline–taxane-based chemotherapy (51.1%). A relationship with the treatment was declared in 27.3% of the cases. An autopsy was performed in 13.6% of patients.
Conclusions
Death during study treatment was mainly related to infections, and patients with advanced disease, high BMI, underlying comorbidities, CRFs and concomitant medications. If considered for study participation these patients need careful monitoring due to their higher risk for death on study.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anthracyclines - adverse effects</subject><subject>Anthracyclines - therapeutic use</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Autopsy</subject><subject>Body Mass Index</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - mortality</subject><subject>Breast Neoplasms - pathology</subject><subject>Bridged-Ring Compounds - adverse effects</subject><subject>Bridged-Ring Compounds - therapeutic use</subject><subject>Cancer</subject><subject>Cancer Research</subject><subject>Chemotherapy</subject><subject>Clinical trials</subject><subject>Comorbidity</subject><subject>Female</subject><subject>Germany</subject><subject>Heart Failure - complications</subject><subject>Humans</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Oncology</subject><subject>Oncology, Experimental</subject><subject>Original Article</subject><subject>Patient Safety</subject><subject>Pneumonia - complications</subject><subject>Prospective Studies</subject><subject>Pulmonary embolism</subject><subject>Pulmonary Embolism - complications</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Risk Factors</subject><subject>Sepsis - complications</subject><subject>Surgery</subject><subject>Surgical Oncology</subject><subject>Taxoids - adverse effects</subject><subject>Taxoids - therapeutic use</subject><issn>1340-6868</issn><issn>1880-4233</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc1LHjEQxoNUqr7tP-ChLPTSy-ok2Y9sbyK1CkIveugp5GOikX2zb5Os4H9vtqtCQcocMgy_Z5g8DyHHFE4oQH-aKGOC1UCHGmAYoOZ75JAKAXXDOP9Qet5A3YlOHJCjlB4AGt5D95EccMrahgE9JL8vVFZjhY8YcqrsHH24q8zogzdlnKNXY_peqVAINc4q-ylUk6ssqnz_xuuIKuXKqGAwVinP1mP6RPZdEePnl3dDbi9-3Jxf1te_fl6dn13Xhosh11qDtl0PTlvRKmsU55Yprl2LfWu4sy1tqNV2ACfcwNryHRx4xzTlgtPO8Q35tu7dxenPjCnLrU8Gx1EFnOYkGWuhW2BR0K8reqdGlD64KUdlFlye9YuZ0BbjNuTkHaqUxa03U0Dny_wfAVsFJk4pRXRyF_1WxSdJQS5JyTUpWZKSf5OSi-jLy9mz3qJ9k7xGUwC-Amm3mIxRPkxzDMXK_619BsgbnYI</recordid><startdate>20191101</startdate><enddate>20191101</enddate><creator>Furlanetto, Jenny</creator><creator>von Minckwitz, Gunter</creator><creator>Lederer, Bianca</creator><creator>Möbus, Volker</creator><creator>Schneeweiss, Andreas</creator><creator>Huober, Jens</creator><creator>Fasching, Peter A.</creator><creator>Gerber, Bernd</creator><creator>Bauerfeind, Ingo</creator><creator>Nitz, Ulrike</creator><creator>Lück, Hans-Joachim</creator><creator>Hanusch, Claus</creator><creator>Thomssen, Christoph</creator><creator>Untch, Michael</creator><creator>Nekljudova, Valentina</creator><creator>Mehta, Keyur</creator><creator>Loibl, Sibylle</creator><general>Springer Japan</general><general>Springer</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20191101</creationdate><title>Fatal events during clinical trials: an evaluation of deaths during breast cancer studies</title><author>Furlanetto, Jenny ; von Minckwitz, Gunter ; Lederer, Bianca ; Möbus, Volker ; Schneeweiss, Andreas ; Huober, Jens ; Fasching, Peter A. ; Gerber, Bernd ; Bauerfeind, Ingo ; Nitz, Ulrike ; Lück, Hans-Joachim ; Hanusch, Claus ; Thomssen, Christoph ; Untch, Michael ; Nekljudova, Valentina ; Mehta, Keyur ; Loibl, Sibylle</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c389t-bb0bd670fbd85adca33d2a3bf5e75c3fd5141dbd90f8f925686e9362b138316f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anthracyclines - adverse effects</topic><topic>Anthracyclines - therapeutic use</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Autopsy</topic><topic>Body Mass Index</topic><topic>Breast cancer</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - mortality</topic><topic>Breast Neoplasms - pathology</topic><topic>Bridged-Ring Compounds - adverse effects</topic><topic>Bridged-Ring Compounds - therapeutic use</topic><topic>Cancer</topic><topic>Cancer Research</topic><topic>Chemotherapy</topic><topic>Clinical trials</topic><topic>Comorbidity</topic><topic>Female</topic><topic>Germany</topic><topic>Heart Failure - complications</topic><topic>Humans</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Oncology</topic><topic>Oncology, Experimental</topic><topic>Original Article</topic><topic>Patient Safety</topic><topic>Pneumonia - complications</topic><topic>Prospective Studies</topic><topic>Pulmonary embolism</topic><topic>Pulmonary Embolism - complications</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Risk Factors</topic><topic>Sepsis - complications</topic><topic>Surgery</topic><topic>Surgical Oncology</topic><topic>Taxoids - adverse effects</topic><topic>Taxoids - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Furlanetto, Jenny</creatorcontrib><creatorcontrib>von Minckwitz, Gunter</creatorcontrib><creatorcontrib>Lederer, Bianca</creatorcontrib><creatorcontrib>Möbus, Volker</creatorcontrib><creatorcontrib>Schneeweiss, Andreas</creatorcontrib><creatorcontrib>Huober, Jens</creatorcontrib><creatorcontrib>Fasching, Peter A.</creatorcontrib><creatorcontrib>Gerber, Bernd</creatorcontrib><creatorcontrib>Bauerfeind, Ingo</creatorcontrib><creatorcontrib>Nitz, Ulrike</creatorcontrib><creatorcontrib>Lück, Hans-Joachim</creatorcontrib><creatorcontrib>Hanusch, Claus</creatorcontrib><creatorcontrib>Thomssen, Christoph</creatorcontrib><creatorcontrib>Untch, Michael</creatorcontrib><creatorcontrib>Nekljudova, Valentina</creatorcontrib><creatorcontrib>Mehta, Keyur</creatorcontrib><creatorcontrib>Loibl, Sibylle</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Breast cancer (Tokyo, Japan)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Furlanetto, Jenny</au><au>von Minckwitz, Gunter</au><au>Lederer, Bianca</au><au>Möbus, Volker</au><au>Schneeweiss, Andreas</au><au>Huober, Jens</au><au>Fasching, Peter A.</au><au>Gerber, Bernd</au><au>Bauerfeind, Ingo</au><au>Nitz, Ulrike</au><au>Lück, Hans-Joachim</au><au>Hanusch, Claus</au><au>Thomssen, Christoph</au><au>Untch, Michael</au><au>Nekljudova, Valentina</au><au>Mehta, Keyur</au><au>Loibl, Sibylle</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Fatal events during clinical trials: an evaluation of deaths during breast cancer studies</atitle><jtitle>Breast cancer (Tokyo, Japan)</jtitle><stitle>Breast Cancer</stitle><addtitle>Breast Cancer</addtitle><date>2019-11-01</date><risdate>2019</risdate><volume>26</volume><issue>6</issue><spage>826</spage><epage>834</epage><pages>826-834</pages><issn>1340-6868</issn><eissn>1880-4233</eissn><abstract>Background
Information on deaths occurring during oncological clinical trials has never been systematically assessed. Here, we examine the incidence of death and the profile of patients who died during randomized clinical breast cancer (BC) trials.
Methods
Information on fatal events during German Breast Group (GBG) led BC trials was prospectively captured. Data were derived from the trial databases and death narratives. All deaths were evaluated for possible causes, underlying conditions, treatment relatedness, time point and rate of autopsies.
Results
From 12/1996 to 01/2017, 23,387 patients were treated within 32 trials. Of those 88 (0.4%) died on therapy within 17 trials. Median age was 64 [range 35–84] years, 63.2% of patients had a body mass index (BMI) ≥ 25 kg/m
2
; 65.9% 1–3 and 22.7% ≥ 4 comorbidities; 61.4% 1–2 cardiovascular risk factors (CRFs); 26.4% took > 3 drugs; 81.7% had ECOG 0; 50.0% stage III, 76.7% luminal BC. The main causes of death were infection (38.6%; of those, 82.3% sepsis, 17.6% pneumonia), heart failure (14.8%), and pulmonary embolism (13.6%). Fatal events mainly occurred within the first 4 therapy cycles (55.7%), in the investigational arm (66.7%) and under anthracycline–taxane-based chemotherapy (51.1%). A relationship with the treatment was declared in 27.3% of the cases. An autopsy was performed in 13.6% of patients.
Conclusions
Death during study treatment was mainly related to infections, and patients with advanced disease, high BMI, underlying comorbidities, CRFs and concomitant medications. If considered for study participation these patients need careful monitoring due to their higher risk for death on study.</abstract><cop>Tokyo</cop><pub>Springer Japan</pub><pmid>31254201</pmid><doi>10.1007/s12282-019-00990-3</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1340-6868 |
| ispartof | Breast cancer (Tokyo, Japan), 2019-11, Vol.26 (6), p.826-834 |
| issn | 1340-6868 1880-4233 |
| language | eng |
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| source | MEDLINE; SpringerLink Journals |
| subjects | Adult Aged Aged, 80 and over Anthracyclines - adverse effects Anthracyclines - therapeutic use Antineoplastic Combined Chemotherapy Protocols - adverse effects Autopsy Body Mass Index Breast cancer Breast Neoplasms - drug therapy Breast Neoplasms - mortality Breast Neoplasms - pathology Bridged-Ring Compounds - adverse effects Bridged-Ring Compounds - therapeutic use Cancer Cancer Research Chemotherapy Clinical trials Comorbidity Female Germany Heart Failure - complications Humans Medicine Medicine & Public Health Middle Aged Oncology Oncology, Experimental Original Article Patient Safety Pneumonia - complications Prospective Studies Pulmonary embolism Pulmonary Embolism - complications Randomized Controlled Trials as Topic Risk Factors Sepsis - complications Surgery Surgical Oncology Taxoids - adverse effects Taxoids - therapeutic use |
| title | Fatal events during clinical trials: an evaluation of deaths during breast cancer studies |
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