scholarly journals Retrospective Study of Adverse Events of Chemotherapy in Cats

2018 ◽  
Vol 46 (1) ◽  
pp. 12
Author(s):  
Simone Carvalho dos Santos Cunha ◽  
Franciele Basso Silva ◽  
Katia Barão Corgozinho ◽  
Kássia Valéria Gomes Coelho da Silva ◽  
Ana Maria Reis Ferreira
Keyword(s):  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Events ◽  
Case Series ◽  
Grading System ◽  
Oncology Group ◽  
Chemotherapy Drugs ◽  
Chemotherapy Administration ◽  
Response To Chemotherapy ◽  
Grade Ii

Background: Clients who seek veterinary care for pets with cancer are often concerned about the potential negative impact of chemotherapeutic treatments on their animals’ quality of life. A consensus currently exists in veterinary oncology regarding the quantification and rating of adverse treatment effects in dogs and cats in response to chemotherapy agents. This grading system is referred to as Veterinary Cooperative Oncology Group - Common Terminology Criteria for Adverse Events. The purpose of this retrospective case series was to investigate the delayed acute effects of chemotherapy drugs in cats receiving cancer treatment.Materials, Methods & Results: Medical records were reviewed to determine the chemotherapy agent used and delayed adverse effects. Side effects were classified according to Veterinary Co-operative Oncology Group grading. All cats were evaluated after the first chemotherapy administration, after a single dose. The reported effects included hematologic effects (e.g., neutropenia, thrombocytopenia, increases in liver enzymes, and azotemia), gastrointestinal effects (e.g., vomiting, diarrhea, and inappetence), and sepsis. All of the cats in this study received ondansetron and omeprazol  in the first five days following chemotherapy administration. If vomiting occurred with oral medication, maropitant was administered subcutaneously for three consecutive days. If diarrhea (> grade II) occurred, probiotics were administered for seven days. Hematologic examination was performed 3-14 days after chemotherapy. If neutropenia (> grade III) occurred, Human granulocyte colony stimulating factor was administered subcutaneously for three consecutive days together with prophylactic antibiotics. Lomustine, carboplatin, vincristine, doxorubicin, cyclophosphamide, mitoxantrone, and vinblastine were administered in 33%, 19%, 16%, 5%, 16%, 10% and 2% of the cases examined, respectively. The most common adverse events were vomiting, inappetence, neutropenia, and thrombocytopenia. Vomiting occurred in 6% cases, most of them associated with cyclophosphamide. Inappetence/anorexia affected 12% of the cases, mostly those involving cyclophosphamide or doxorubicin. Neutropenia was observed in 22% of the cases, with cyclophosphamide, followed by carboplatin and lomustine. According to the current grading system of adverse effects induced by chemotherapy, grade I toxicity was observed in 83% of the cases, whiles grade II-IV were observed in 7%, 8%, and 2% of the cases examined, respectively.Discussion: In general, the chemotherapy regimens in the cases examined were well tolerated. The toxicity experienced was infrequent and mostly mild, thereby resulting in satisfactory tolerability of the chemotherapy regimens. According to the current grading system for the adverse effects of chemotherapy, 83% of the cases examined included grade I, indicating that most of the cats experienced asymptomatic, or mild symptoms, and medical intervention was not needed. In previous studies of dogs and cats, a severe adverse event following chemotherapy was reported for fewer than 1 in 4 animals, and approximately 3-5% experienced a serious adverse event that led to hospitalization. In the present study, 2% of the cats experienced serious or life threatening adverse events. The only chemotherapeutic agent that was associated with inappetence, vomiting, and neutropenia was cyclophosphamide. Based on the data examined, we would recommend that cyclophosphamide should be used with caution for the treatment of cancer in cats, with adequate antiemetic and nutritional support available if needed. In addition, febrile neutropenia/sepsis may be avoided by using a fractionated schedule.

scholarly journals Characteristics of voluntary reporting of adverse drug events related to antipsychotics in Australia: 14-year analysis

2021 ◽  
Vol 12 ◽  
pp. 204209862110128
Author(s):  
Hanan Khalil ◽  
Dimi Hoppe ◽  
Nabil Ameen
Keyword(s):  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Events ◽  
Neuroleptic Malignant Syndrome ◽  
Antipsychotic Drug ◽  
Antipsychotic Drugs ◽  
Common Adverse Event ◽  
Drug Misuse ◽  
Large Databases ◽  
Chi Squared

Background: Retrospective analyses of large databases of treated patients can provide useful links to the presence of drug misuse or rare and infrequent adverse effects, such as agranulocytosis, diabetic ketoacidosis or neuroleptic malignant syndrome. The aim of this study is to describe the adverse effects to antipsychotics reported in the Australian Database of Adverse Event Notifications (DAEN). Methods: Data were collected from the DAEN – a spontaneous reporting database. The database, which covered the period from January 2004 to December 2017, was obtained from the Therapeutic Goods Administration (TGA) website ( www.TGA.gov ). The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. All data were analysed descriptively. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant. Results: A total of 7122 adverse events associated with the antipsychotics aripiprazole, clozapine, haloperidol, olanzapine, paliperidone, pimozide, quetiapine and risperidone were reported to the TGA between January 2004 and December 2017. On average, there were 2.6 adverse events reported for each case. The most common adverse event reported for antipsychotics was neuroleptic malignant syndrome. There were no significant differences in the number of co-medications, formulations, indications, therapeutic dose, hospital admission and overdose among the antipsychotics between paediatric and adult populations. However, there were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years) ( p < 0.05, chi squared test). Conclusion: The antipsychotic drug associated with the highest adverse events in adults was clozapine, followed by olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. Plain language summary Adverse events reported of antipsychotics Background: Retrospective analyses of large databases of treated patients can provide useful clues to the presence of drug misuse or rare and infrequent adverse effects associated with antipsychotics. The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. Methods: All data were analysed descriptively and investigated for any associations between the variables collected. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant. Results: The antipsychotic drug associated with the highest adverse events was clozapine, followed by olanzapine. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. Conclusion: There were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years).Keywords: Antipsychotics, adverse effects, adverse events, safety

scholarly journals Pharmacogenetic Predictors of Adverse Events and Response to Chemotherapy in Metastatic Colorectal Cancer: Results From North American Gastrointestinal Intergroup Trial N9741

2010 ◽  
Vol 28 (20) ◽  
pp. 3227-3233 ◽  
Author(s):  
Howard L. McLeod ◽  
Daniel J. Sargent ◽  
Sharon Marsh ◽  
Erin M. Green ◽  
Cristi R. King ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
North American ◽  
Drug Transport ◽  
Disease Free Survival ◽  
Cellular Targets ◽  
Chemotherapy Drugs ◽  
The North ◽  
Response To Chemotherapy ◽  
Variant Genotype

Purpose With three available chemotherapy drugs for advanced colorectal cancer (CRC), response rate (RR) and survival outcomes have improved with associated morbidity, accentuating the need for tools to select optimal individualized treatment. Pharmacogenetics identifies the likelihood of adverse events or response based on variants in genes involved in drug transport, metabolism, and cellular targets. Patients and Methods Germline DNA was extracted from 520 patients on the North American Gastrointestinal Intergroup N9741 study. Three study arms were evaluated: IFL (fluorouracil [FU] + irinotecan [IRN]), FOLFOX (FU + oxaliplatin), and IROX (IRN + oxaliplatin). Information on adverse events, response, and disease-free survival was available. Thirty-four variants in 15 candidate genes for analysis based on previous associations with adverse events or outcome were assessed. Genotyping was performed using pyrosequencing. Results All variants were polymorphic. The homozygous UGT1A1*28 allele observed in 9% of patients was associated with risk of grade 4 neutropenia in patients on IROX (55% v 15%; P = .002). Deletion in GSTM1 was associated with grade 4 neutropenia after FOLFOX (28% v 16%; P = .02). Patients with a homozygous variant genotype for GSTP1 were more likely to discontinue FOLFOX because of neurotoxicity (24% v 10%; P = .01). The presence of a CYP3A5 variant was significantly associated with RR on IFL (29% v 60%; P = .0074). Most previously published genotype-toxicity or -efficacy relationships were not validated in this study. Conclusion This study provides a platform to evaluate pharmacogenetic predictors of response or severe adverse events in advanced CRC. Pharmacogenetic studies can be conducted in multicenter trials, and our findings demonstrate that with continued research, clinical application is practical.

scholarly journals Common Uses and Adverse Effects of Hyperbaric Oxygen Therapy in a Cohort of Small Animal Patients: A Retrospective Analysis of 2,792 Treatment Sessions

2021 ◽  
Vol 8 ◽  
Author(s):  
Christina Montalbano ◽  
Caroline Kiorpes ◽  
Lindsay Elam ◽  
Erin Miscioscia ◽  
Justin Shmalberg
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Events ◽  
Hyperbaric Oxygen Therapy ◽  
Medical Records ◽  
Oxygen Therapy ◽  
Oxygen Toxicity ◽  
Small Animals

Hyperbaric oxygen therapy (HBOT) is commonly utilized for various human conditions with a low incidence of major adverse effects (0.002–0.035%). Despite growing use in veterinary patients, there remains a paucity of literature describing its use and associated complications. The purpose of this study was to report clinical use of HBOT in small animals and identify the rate of major adverse events at a university teaching hospital. Electronic medical records were searched for small animals receiving HBOT between November 2012 and February 2020. Data extracted from the medical records included signalment, treatment indication, and adverse events. Treatment sessions totaled 2,792 in 542 dogs, 24 cats, and 10 pocket pets and exotics. Common indications included neurologic injuries (50.4%), tissue healing (31.4%), control of oomycete infection (5.5%), neoplasia or post-radiation injury (5.4%), and various miscellaneous conditions (7.4%). Observed minor adverse events included agitation in two dogs and vomiting in three dogs. The most common major adverse event was central nervous system (CNS) oxygen toxicity in 19 dogs. Central nervous system oxygen toxicity, manifesting as focal or generalized seizures, occurred in 0.7% of treatment sessions, with increasing age (p = 0.01) and female sex (p = 0.01) identified as risk factors. One dog developed pulmonary edema following HBOT which is a reported adverse event in humans or may have been a manifestation of progression of the dog's underlying disease. No adverse events were noted in cats or other species. In conclusion, HBOT appeared safe across various indications, although oxygen toxicity affecting the CNS was higher than reports in humans. Future prospective, randomized, controlled trials should evaluate specific clinical indications and outcomes.

Prehospital Use of Aspirin Rarely Is Associated with Adverse Events

2004 ◽  
Vol 19 (04) ◽  
pp. 362-365 ◽  
Author(s):  
Dan Quan ◽  
Frank LoVecchio ◽  
Bryan Clark ◽  
John V. Gallagher
Keyword(s):  
Adverse Event ◽  
Chest Pain ◽  
Adverse Events ◽  
Case Series ◽  
Fire Department ◽  
Prehospital Setting ◽  
Retrospective Case ◽  
Cardiac Syndrome ◽  
Coronary Syndromes ◽  
Aspirin Ingestion

AbstractIntroduction:Aspirin is commonly administered for acute coronary syndromes in the prehospital setting. Few studies have addressed the incidence of adverse effects associated with prehospital administration of aspirin. Objective: To determine the incidence of adverse events following the administration of aspirin by prehospital personnel.Methods:Multi-center, retrospective, case series that involved all patients who received aspirin in the prehospital setting from (01 August 1999–31 January 2000). Patient encounter forms of the emergency medical services (EMS) of a metropolitan fire department were reviewed. All patients who had a potential cardiac syndrome (i.e., chest pain, dyspnea) as documented on the EMS forms were included in the review. Exclusion criteria included failure to meet inclusion criteria, and chest pain secondary to apparent noncardiac causes (i.e., trauma). Hospital charts were reviewed from a subset of patients at the participating hospitals. The major outcome was an adverse event following prehospital administration of aspirin. This outcome was evaluated during the EMS encounter, at emergency department discharge, or at six and 24-hours post-aspirin ingestion. An adverse event secondary to aspirin ingestion was defined as anaphylaxis or allergic reactions, such as rash or respiratory changes.Results:A total of 25,600 EMS encounter forms were reviewed, yielding 2,399 patients with a potential cardiac syndrome. Prior to EMS arrival, 585 patients had received aspirin, and 893 were administered aspirin by EMS personnel. No patients had an adverse event during the EMS encounter. Of these patients, 229 were transported to participating hospitals and 219 medical records were available for review with no adverse reactions recorded during their hospital course.Conclusion:Aspirin is rarely associated with adverse events when administered by prehospital personnel for presumed coronary syndromes.

scholarly journals Discovering Outliers of Potential Drug Toxicities Using a Large-scale Data-driven Approach

2016 ◽  
Vol 15 ◽  
pp. CIN.S39549
Author(s):  
Jake Luo ◽  
Ron A. Cisler
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Events ◽  
Large Scale ◽  
Data Driven ◽  
Cancer Drugs ◽  
Data Driven Approach ◽  
Grubbs Test

We systematically compared the adverse effects of cancer drugs to detect event outliers across different clinical trials using a data-driven approach. Because many cancer drugs are toxic to patients, better understanding of adverse events of cancer drugs is critical for developing therapies that could minimize the toxic effects. However, due to the large variabilities of adverse events across different cancer drugs, methods to efficiently compare adverse effects across different cancer drugs are lacking. To address this challenge, we present an exploration study that integrates multiple adverse event reports from clinical trials in order to systematically compare adverse events across different cancer drugs. To demonstrate our methods, we first collected data on 186,339 clinical trials from ClinicalTrials.gov and selected 30 common cancer drugs. We identified 1602 cancer trials that studied the selected cancer drugs. Our methods effectively extracted 12,922 distinct adverse events from the clinical trial reports. Using the extracted data, we ranked all 12,922 adverse events based on their prevalence in the clinical trials, such as nausea 82%, fatigue 77%, and vomiting 75.97%. To detect the significant drug outliers that could have a statistically high possibility of causing an event, we used the boxplot method to visualize adverse event outliers across different drugs and applied Grubbs’ test to evaluate the significance. Analyses showed that by systematically integrating cross-trial data from multiple clinical trial reports, adverse event outliers associated with cancer drugs can be detected. The method was demonstrated by detecting the following four statistically significant adverse event cases: the association of the drug axitinib with hypertension (Grubbs’ test, P < 0.001), the association of the drug imatinib with muscle spasm ( P < 0.001), the association of the drug vorinostat with deep vein thrombosis ( P < 0.001), and the association of the drug afatinib with paronychia ( P < 0.01).

How Accurate Is Clinician Reporting of Chemotherapy Adverse Effects? A Comparison With Patient-Reported Symptoms From the Quality-of-Life Questionnaire C30

2004 ◽  
Vol 22 (17) ◽  
pp. 3485-3490 ◽  
Author(s):  
Erik K. Fromme ◽  
Kristine M. Eilers ◽  
Motomi Mori ◽  
Yi-Ching Hsieh ◽  
Tomasz M. Beer
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Events ◽  
Life Questionnaire ◽  
European Organization ◽  
Quality Of Life Questionnaire ◽  
Patient Reported

Purpose Adverse events in chemotherapy clinical trials are assessed and reported by clinicians, yet clinician accuracy in assessing symptoms has been questioned. We compared patient reporting of eight symptoms using a validated instrument, the European Organization for the Research and Treatment of Cancer Quality-of-Life Questionnaire C30 (QLQ-C30 or QLQ) with physicians' reporting of the same symptoms in the study's adverse events log. Patients and Methods Thirty-seven men with metastatic, androgen-independent prostate cancer enrolled onto a phase II trial of weekly calcitriol and docetaxel completed the QLQ every 4 weeks for up to 28 weeks. A patient-reported symptom was defined as an increase in a QLQ symptom score by at least 10 points (0 to 100 scale), sustained for at least 4 weeks. A physician-reported symptom was considered present if it was ever documented in the adverse event log. Results Forty-nine (new or worsened) symptoms were detected by both physician and QLQ, 48 symptoms were detected by the physician alone, and 55 symptoms were detected by the QLQ alone. They agreed on the absence of a symptom in 102 instances of 254 possible opportunities. Their uncorrected agreement was 59.4%, but Cohen's κ, a coefficient of agreement that corrects for chance, was 0.15, indicating only slight agreement. Using the QLQ as the standard, overall physician sensitivity and specificity was 47% and 68%, respectively, although it varied considerably among symptoms. Conclusion Even in a tightly controlled clinical trial, physician reporting was neither sensitive nor specific in detecting common chemotherapy adverse effects. Tools for collecting patient-reported adverse event data in chemotherapy clinical trials should be developed.

scholarly journals Adverse Events Associated with Fluoroscopically Guided Zygapophyseal Joint Injections

2014 ◽  
Vol 4;17 (4;7) ◽  
pp. 297-304
Author(s):  
Zack McCormick
Keyword(s):  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Events ◽  
Injection Site ◽  
Facet Joint ◽  
Zygapophyseal Joint ◽  
Systematic Analysis ◽  
Vasovagal Reaction ◽  
The Mean

Background: In spite of the widespread performance of intra-articular zygapophyseal joint (IAZJ) injections, we know of no systematic analysis to date that examines the risks and types of adverse events when IAZJ injections are performed. Objective: To describe the type, incidence, and factors contributing to adverse events associated with fluoroscopically guided IAZJ injections. Study Design: A retrospective, cohort study of English-speaking adults aged 18 – 90 years who underwent fluoroscopically guided IAZJ injections between March 8, 2004, and April 19, 2007. Following IAZJ injections, 3 senior researchers recorded the presence and type of adverse events. The relationship of adverse events with age, gender, fluoroscopy time, vital signs, and trainee presence was analyzed with Fisher’s exact or Wilcoxon rank sum 2-sided tests. Frequency of immediate (during or immediately after the procedure) or delayed (within 24 – 72 hours following the procedure) adverse events. Setting: Tertiary, academic, outpatient physical medicine and rehabilitation interventional spine clinic. Results: One hundred ninety-one patients (111 men) underwent 239 procedures. The mean and standard deviation (SD) of subject age was 56.4 (16.6) years ranging from 20 to 89. The mean and SD of pre-procedure 11-point Visual Analog Pain Scale was 5.5 (2.2) ranging from 0 to 10, and for post-procedure was 2.6 (2.6) ranging from 0 to 10. Trainees were involved in 52.3% of procedures. Reported immediate adverse events were vasovagal reaction (3.8%, n = 9) and steroid clogged needle (0.4%, n = 1). Follow-up data were available for 185/239 procedures (77.4%). There were 35 adverse events reported at mean follow-up interval of 1.8 days, of which the most frequent were injection site soreness (6.0%, n = 11), pain exacerbation (4.3%, n = 8), sleeplessness (2.2%, n = 4), and transient headache (1.6%, n = 3). Patient gender, age, trainee involvement, pre-procedural pain score, systolic or diastolic blood pressure, pulse, hemoglobin saturation as measured by pulse oximetry, volume of corticosteroid injected, and duration of fluoroscopy were not found to have a significant effect on immediate or delayed adverse events. Limitations: This study is limited by a 24- to 72-hour follow-up window, which may have also been too small to capture more delayed complications, and a sample size too small to accurately define the incidence of rare complications. Conclusion: Fluoroscopically guided IAZJ injections have minimal adverse effects. The most common immediate adverse event was vasovagal reaction and most common delayed adverse event was injection site soreness. Key words: Fluoroscopic injection, facet joint, zygapophyseal joint, complications, adverse effects, steroid injection

Application of FDA Adverse Event Report Data to the Surveillance of Dietary Botanical Supplements

2008 ◽  
Vol 42 (5) ◽  
pp. 653-660 ◽  
Author(s):  
Robert B Wallace ◽  
Brian M Gryzlak ◽  
M Bridget Zimmerman ◽  
Nicole L Nisly
Keyword(s):  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Events ◽  
Product Information ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Adverse Event Report ◽  
St John’S Wort ◽  
St John's Wort ◽  
Botanical Supplements

Background: Concerns have been raised about the sufficiency of dietary botanical supplement (DBS) surveillance in the US. The Food and Drug Administration's Center for Food Safety and Applied Nutrition's Adverse Event Reporting System (CAERS) represents one of the few existing surveillance mechanisms, but it has not been well characterized with respect to DBS adverse effects. Objective: To characterize data on DBSs associated with adverse event reports submitted to CAERS. Methods: We requested and obtained CAERS data from 1999 to 2003 involving adverse effects associated with the 6 most frequently used DBSs: Echinacea, ginseng, garlic, Ginkgo biloba, St. John's wort, and peppermint. We summarized and characterized the adverse event reports received, focusing on the composition of the DBSs and the nature of associated adverse events. We also cross-referenced reported single-ingredient DBSs with corresponding available product information. A sample of CAERS cases associated with signal DBSs was also characterized in detail. Results: CAERS reports involving ginseng DBSs were most frequently reported during the study period, whereas reports involving St. John's wort were the least frequently reported. Most CAERS reports involved multiple-ingredient DBSs, and 3-13% of reports involved multiple DBSs. Gastrointestinal and neurologic problems were the most common clinical outcomes among single-ingredient DBS-associated adverse events. Conclusions: CAERS surveillance of DBS adverse effects is potentially as effective as other passive surveillance methods, but the number of reports is relatively small, validation is incomplete, and some inconsistencies within reports were found. Reports in CAERS may underrepresent DBS adverse events associated with DBS consumption.

scholarly journals Small changes in calcium replacement therapy triggering hypercalcaemia and rising creatinine – a case series

2019 ◽  
Vol 65 (1) ◽  
pp. 32-37 ◽  
Author(s):  
Luis Loureiro Harrison ◽  
Alison Crooks ◽  
Michael Kelly ◽  
Fiona Green ◽  
Thalakunte Muniraju
Keyword(s):  
Vitamin D ◽  
Renal Failure ◽  
Adverse Effects ◽  
Adverse Events ◽  
Replacement Therapy ◽  
Thyroid Surgery ◽  
Case Series ◽  
Baseline Creatinine ◽  
Vitamin D Supplements ◽  
Medication Changes

In this article, we present four cases of renal failure secondary to hypercalcaemia which were brought to the attention of our hospital's nephrology team. These happened in the setting of simple medication changes for hypoparathyroidism post-thyroid surgery. These cases have in common minor changes in preparations leading to significant adverse events. In two cases, excipient changes were the only changes identified in the patients' regimen. In all cases, cessation of the offending calcium preparation and treatment with IV rehydration led to a return to baseline creatinine levels. Communicating to patients the importance of consistency in how calcium and vitamin D supplements are taken is crucial in preventing adverse effects. Prescribers should be aware of excipient changes and that these are not always clinically insignificant.

scholarly journals Endocrinology trial design: adverse event reporting in randomised controlled trials of recombinant human GH in GH-deficient adults

2002 ◽  
Vol 175 (2) ◽  
pp. 545-552 ◽  
Author(s):  
J Bryant ◽  
E Loveman ◽  
C Cave ◽  
D Chase ◽  
R Milne
Keyword(s):  
Quality Of Life ◽  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Events ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Number Of Patients ◽  
Randomised Controlled ◽  
The Impact

We have evaluated the reporting of withdrawals due to adverse effects and specific adverse effects in randomised controlled trials of recombinant human GH in adults. A systematic review was carried out of randomised controlled trials of the clinical effectiveness of recombinant human GH in adults with GH deficiency in relation to impact on quality of life. Trials were identified from searching electronic databases, bibliographies of related articles and consulting experts. There was reporting of withdrawals due to adverse effects and specific adverse effects. Rates of oedema and arthralgia were reported in included trials. Seventeen randomised controlled trials, published between 1990 and 1999, met the inclusion criteria for the review. Nine trials reported data on the effectiveness of GH on quality of life in adults. Only five trials (29%) reported both withdrawals from the study because of adverse events and specific adverse events with numbers per study arm and per type. Six further trials (35%) reported either withdrawal details or specific adverse event details or partial data on specific adverse events. Six trials (35%), however, did not report information on either withdrawals or specific adverse events. Ten of the 17 studies (59%) reported the number of patients who withdrew from the study due to adverse events per study arm and type of adverse event per study arm. Seven of the 17 trials (41%) reported the number of specific adverse events per study arm and six (35%) reported the type per study arm. The reporting of adverse events in randomised controlled trials of GH is variable and not consistent across trials. It is not possible to assess the impact that adverse events may have had on unblinding patients, and therefore the extent to which the effects of GH may have been overestimated. Therefore those conducting endocrinology trials in the future need to pay attention to the reporting of withdrawals due to adverse events and specific adverse events.

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