scholarly journals A retrospective study: root cause analysis of reported serious adverse event and development of corrective action and preventive action for deviated serious adverse event reports at a clinical trial site management office

2020 ◽  
Vol 7 (3) ◽  
pp. 194
Author(s):  
Dayanand Raddi ◽  
Revena S. Deveriniti ◽  
M. S. Ganachari ◽  
Geetanjali Salimath
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Retrospective Study ◽  
Case Reports ◽  
Corrective Action ◽  
Preventive Action ◽  
Initial Report ◽  
Serious Adverse Event ◽  
Root Cause ◽  
Safety Reporting

<p class="abstract"><strong>Background:</strong> Serious adverse events (SAEs) are preventable if reported on time. Assessment of harm caused by clinical trials is difficult than assessing the benefits as it relied on the information as recorded by the study team. Hence it is important to have knowledge about quality safety reporting. The objectives of the study were to assess root cause for the timeline deviation found in SAE report and to develop the corrective action and preventive action to minimize deviation rate.</p><p class="abstract"><strong>Methods:</strong> A retrospective study was conducted in KLE’s Hospital and MRC, Belagavi. Data was collected from SAE documented trial study files. Between August 2016 to August 2019, 25 SAE occurred during clinical trials which were included in the study through complete enumeration and purposive sampling.</p><p class="abstract"><strong>Results:</strong> Data was analyzed for SAE reporting timeline where in no deviation was found in initial report. It was seen that all SAEs were not related to investigational product. The narrations of SAE were according to standardized format as per Ethics Committee review report. A gap was observed between onset of SAE and initial report in 16 case reports.</p><p class="abstract"><strong>Conclusions: </strong>The study concluded that there was a lag in reporting from onset of SAE to initial report even though there was no deviation observed in the initial report timeline. The main contributing factors were admitting in different hospital without information and lack of knowledge by subjects or their relatives which shows the need of awareness about quality safety reporting.</p>

Serious adverse event reporting in investigator‐initiated clinical trials

2016 ◽  
Vol 204 (6) ◽  
pp. 231-233 ◽  
Author(s):  
Sophie Wallace ◽  
Paul S Myles ◽  
Nikolajs Zeps ◽  
John R Zalcberg
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
Serious Adverse Event

Cellulitis Secondary to Liquid Nitrogen Cryotherapy: Case Report and Literature Review

2017 ◽  
Vol 21 (4) ◽  
pp. 334-338 ◽  
Author(s):  
Christina M. Huang ◽  
Emily Y. Lu ◽  
Mark G. Kirchhof
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Liquid Nitrogen ◽  
Case Reports ◽  
Secondary Infection ◽  
Case Series ◽  
Risk Of Infection ◽  
True Incidence ◽  
Length Of Treatment ◽  
Skin Conditions

Background: Liquid nitrogen cryotherapy is a commonly used technique to treat a wide variety of dermatologic conditions including actinic keratoses, non-melanoma skin cancers, verrucae, and seborrheic keratoses. The risks associated with liquid nitrogen cryotherapy are important to know and discuss with patients prior to treatment. Objective: We report a case of cellulitis secondary to liquid nitrogen cryotherapy for actinic keratosis. We sought to review the literature for an estimate of secondary infection rates following cryotherapy treatment. Methods: We searched Pubmed using the terms cryotherapy and infection or cellulitis. We then looked at articles classified as clinical trials where cryotherapy was used to treat skin conditions. We then selected clinical trials that listed cellulitis or infection as an adverse event. Results and Conclusion: There were no case reports, case series, or review articles detailing the risk of infection from liquid nitrogen cryotherapy. We found 8 articles classified as clinical trials on Pubmed that did list infection as an adverse event. The risk of infection from these studies varied from approximately 2% to 30%. There was a great degree of heterogeneity in treatment sites, length of treatment, and treatment targets. While it is difficult to determine the true incidence of infection from liquid nitrogen cryotherapy, clinicians should endeavor to inform patients of this potential risk.

scholarly journals Text Mining of Adverse Events in Clinical Trials: Deep Learning Approach (Preprint)

2021 ◽  
Author(s):  
Daphne Chopard ◽  
Matthias S Treder ◽  
Padraig Corcoran ◽  
Nagheen Ahmed ◽  
Claire Johnson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Adverse Events ◽  
Critical Role ◽  
Language Model ◽  
Class Imbalance ◽  
International Classification Of Diseases ◽  
Adverse Event Report ◽  
Serious Adverse Event ◽  
Medical Dictionary

BACKGROUND Pharmacovigilance and safety reporting, which involve processes for monitoring the use of medicines in clinical trials, play a critical role in the identification of previously unrecognized adverse events or changes in the patterns of adverse events. OBJECTIVE This study aims to demonstrate the feasibility of automating the coding of adverse events described in the narrative section of the serious adverse event report forms to enable statistical analysis of the aforementioned patterns. METHODS We used the Unified Medical Language System (UMLS) as the coding scheme, which integrates 217 source vocabularies, thus enabling coding against other relevant terminologies such as the International Classification of Diseases–10th Revision, Medical Dictionary for Regulatory Activities, and Systematized Nomenclature of Medicine). We used MetaMap, a highly configurable dictionary lookup software, to identify the mentions of the UMLS concepts. We trained a binary classifier using Bidirectional Encoder Representations from Transformers (BERT), a transformer-based language model that captures contextual relationships, to differentiate between mentions of the UMLS concepts that represented adverse events and those that did not. RESULTS The model achieved a high F1 score of 0.8080, despite the class imbalance. This is 10.15 percent points lower than human-like performance but also 17.45 percent points higher than that of the baseline approach. CONCLUSIONS These results confirmed that automated coding of adverse events described in the narrative section of serious adverse event reports is feasible. Once coded, adverse events can be statistically analyzed so that any correlations with the trialed medicines can be estimated in a timely fashion.

HLA-DRB1*07:01-DQA1*02:01 and UGT1A1*28 allele carriage in hepatic serious adverse event cases identified during lapatinib clinical trials.

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. 547-547 ◽  
Author(s):  
C. F. Spraggs ◽  
L. R. Budde ◽  
L. P. Briley ◽  
C. Cox ◽  
E. Rappold ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Serious Adverse Event

Severe Gemcitabine-Associated Lung Injury in Hodgkins Disease & Other Cancers: Reporting Quality and Clinical Characteristics of Cases Reported in the Medical Literature and to the FDA.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3145-3145 ◽  
Author(s):  
Steven M. Belknap ◽  
Nicolas Slimack ◽  
Timothy Kuzel ◽  
Kenneth R. Carson ◽  
Paul R. Yarnold ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Event ◽  
Lung Injury ◽  
Combination Chemotherapy ◽  
Clinical Characteristics ◽  
Case Reports ◽  
Reporting Quality ◽  
Trial Setting

Abstract Background: In view of concern about substantially increased risk of gemcitabine-associated lung injury (ALI), vigilant post-marketing surveillance is necessary to further characterize the frequency, severity, and clinical features of gemcitabine-associated pulmonary injury. Methods: From 2001–2003, investigators with the Research on Adverse Drug reactions And Reports (RADAR) program compared the clinical characteristics and adverse event reporting quality of gemcitabine-associated lung injury contained in published case reports and adverse event reports submitted in the setting of clinical trials or the non-clinical trial setting. Results: Completeness of reporting was excellent for published case reports and intermediate to poor for FDA adverse event reports from clinical trials or observational studies, including age (100%, 92%, 91%); time to onset of toxicity (100%, 63%, 58%); dose (97%, 63%, 79%); results of imaging studies (94%, 56%, 59%); presence/absence of hypoxia (97%, 6%, 4%); and cause of death (88%, 82%, 66%). Temporal analyses identified a bimodal pattern for the onset of pulmonary symptoms: 90% occurred before 150 days and 8% after 300 days. The highest rates of severe lung injury were in high dose patients co-administered bleomycin (28%) and in lung cancer patients (16%). Conclusions: Reporting completeness for severe gemcitabine-ALI to the FDA from the clinical trial and the non-clinical trial setting is poor, limiting the ability of the RADAR group to comprehensively assess this toxicity. Nonetheless, this toxicity is severe and, as shown in published case reports, frequent in the presence of concomitant pulmonary insults such as bleomycin-containing combination chemotherapy regimens for Hodgkin’s disease and taxol-containig combination chemotherapy regimens for lung cancer. Gemcitabine-associated Acute Lung Injury in Selected Clinical Trials Author DX Other ChemoRx N ALI % Friedberg JW Hodgkin Doxorubicin, Bleomycin, Vinblastine 12 5 42 Bredenfeld H Hodgkin BA_COPP 27 6 22 Chen YM Non-SCLC Vinorelbine 20 5 25 Popa IE Non-SCLC Docetaxel 32 6 19 Herbst RS Non-SCLC Vinorelbine 36 5 14 Blackstock AW Non-SCLC 16 2 13 Bhatia S Non-SCLC Paclitaxel 34 4 12 Safran H Pancr. Ca Paclitaxel, Radiation 19 2 11 Lobo F Breast Ca Vinorelbine, Anthracyclines 21 2 10

scholarly journals Text Mining of Adverse Events in Clinical Trials: Deep Learning Approach

10.2196/28632 ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. e28632
Author(s):  
Daphne Chopard ◽  
Matthias S Treder ◽  
Padraig Corcoran ◽  
Nagheen Ahmed ◽  
Claire Johnson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Adverse Events ◽  
Critical Role ◽  
Language Model ◽  
Class Imbalance ◽  
International Classification Of Diseases ◽  
Adverse Event Report ◽  
Serious Adverse Event ◽  
Medical Dictionary

Background Pharmacovigilance and safety reporting, which involve processes for monitoring the use of medicines in clinical trials, play a critical role in the identification of previously unrecognized adverse events or changes in the patterns of adverse events. Objective This study aims to demonstrate the feasibility of automating the coding of adverse events described in the narrative section of the serious adverse event report forms to enable statistical analysis of the aforementioned patterns. Methods We used the Unified Medical Language System (UMLS) as the coding scheme, which integrates 217 source vocabularies, thus enabling coding against other relevant terminologies such as the International Classification of Diseases–10th Revision, Medical Dictionary for Regulatory Activities, and Systematized Nomenclature of Medicine). We used MetaMap, a highly configurable dictionary lookup software, to identify the mentions of the UMLS concepts. We trained a binary classifier using Bidirectional Encoder Representations from Transformers (BERT), a transformer-based language model that captures contextual relationships, to differentiate between mentions of the UMLS concepts that represented adverse events and those that did not. Results The model achieved a high F1 score of 0.8080, despite the class imbalance. This is 10.15 percent points lower than human-like performance but also 17.45 percent points higher than that of the baseline approach. Conclusions These results confirmed that automated coding of adverse events described in the narrative section of serious adverse event reports is feasible. Once coded, adverse events can be statistically analyzed so that any correlations with the trialed medicines can be estimated in a timely fashion.

Clinical presentation of immune-related colitis associated with PD-1 inhibitor monotherapy (MONO) and combination PD-1/CTLA-4 inhibitors (COMBO) in melanoma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9566-9566 ◽  
Author(s):  
Daniel Ying Wang ◽  
Dae Won Kim ◽  
Neil J. Shah ◽  
Robert Martin Conry ◽  
Rutika Jitesh Mehta ◽  
...  
Keyword(s):  
Adverse Event ◽  
Retrospective Study ◽  
Clinical Features ◽  
Dose Escalation ◽  
Clinical Presentation ◽  
Objective Response ◽  
Serious Adverse Event ◽  
Systemic Steroids ◽  
Steroid Dose ◽  
Grade 5

9566 Background: Ipilimumab-related colitis has been well described, but the clinical presentation of colitis related to MONO or COMBO therapy has not. We aimed to characterize clinical features that define this serious adverse event. Methods: This retrospective study included melanoma pts with colitis screened from 6 academic centers treated with either MONO or COMBO therapy. Clinically relevant colitis was defined as diarrhea/colitis symptoms requiring systemic steroids. The onset, management, and outcomes related to colitis were summarized. Results: We screened 866 pts and identified 72 with clinically relevant colitis. For the MONO cohort, the incidence was 3.5% (23/657) and 23.4% (49/209) in the COMBO cohort. MONO-colitis occurred at a median 33 weeks (wks) into therapy, while median onset was 8 wks with COMBO therapy. One pt had grade 5 colitis from COMBO therapy. Despite the use of systemic steroids, COMBO-colitis needed more infliximab therapy (38.8% vs 26.1%). The median prednisone equivalent dose was higher for COMBO therapy (1.5 vs 1 mg/kg), and the median taper was shorter for MONO-colitis (4 vs 6 wks). Steroid dose-escalation for worsening symptoms during taper was more common with COMBO-colitis (42.9% vs 17.3%). Relapse was similar between cohorts (MONO: 26.1%, COMBO: 20.4%). Relapses occurred more frequently in COMBO therapy with tapers shorter than the median (38.1% vs 25.0%), and more frequently in MONO therapy with steroid doses lower than the median (60% vs 21.7%). MONO-colitis pts (17.4%) were less likely than COMBO-colitis pts (46.9%) to be restarted on PD-1 therapy. When restarted, only 13% with COMBO therapy relapsed as compared to 50% with MONO therapy. Objective response rates for MONO and COMBO cohorts were 72.7% and 56.1%, respectively. Conclusions: Colitis occurred with a much higher incidence in COMBO therapy. MONO-colitis was associated with a milder course with later onset, shorter duration and lower dose of steroids, fewer dose-escalations, and need for infliximab as compared to COMBO therapy. Relapse of colitis was generally associated with shorter steroid tapers for COMBO therapy and lower steroid doses for MONO therapy.

Electroconvulsive Therapy use in a 97-Year-Old Woman

2007 ◽  
Vol 15 (5) ◽  
pp. 427-430 ◽  
Author(s):  
David Burke ◽  
Joanne Shannon ◽  
Alexander Beveridge
Keyword(s):  
Adverse Event ◽  
Electroconvulsive Therapy ◽  
Case Reports ◽  
Case Series ◽  
Serious Adverse Event ◽  
Very Old ◽  
Efficacious Treatment ◽  
Clinical Trial Evidence ◽  
Trial Evidence ◽  
Additional Safety

Objectives: The aim of this paper is to report the use of electroconvulsive therapy (ECT) to successfully treat depression in a 97-year-old woman, and to discuss the safety and efficacy of ECT in the very old. Methods: A case report and review of the literature on the use of ECT to treat depression in the very old is presented. Results: The subject recovered fully from her depression but suffered a serious adverse event (fractured femur) during the course of ECT. Relatively few publications on the use of ECT in the very old were found. The majority of articles concerned patients aged between 65 and 85, with one study including patients up to age 96. Conclusions: There appears to be an absence of randomized clinical trial evidence to support the use of ECT as a treatment for depression in the very old. Based on the limited evidence from case reports and case series, the indications appear to be the same as for younger patients. There do not appear to be any absolute contraindications, and ECT appears to be a safe and efficacious treatment for depression in the very old. However, in the light of our subject's serious adverse event, there may be a need to consider additional safety precautions in the very old. Finally, we believe our patient is the oldest person reported to be successfully treated with suprathreshold ECT.

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