Home About us Contact
|
Home About us Contact | ||
|
|
||
Experienced Adverse Events (experience + adverse_event)
Selected AbstractsSafety and efficacy of transdermal fentanyl in patients with cancer pain: phase IV, Turkish oncology group trialEUROPEAN JOURNAL OF CANCER CARE, Issue 1 2007. KÖMÜRCÜ md We have performed a prospective evaluation of the efficacy, safety and convenience of the transdermal therapeutic system , fentanyl (TTS-F) in Turkish cancer patients when it was newly available in Turkey. Ninety-nine patients with historically confirmed malignancy and pain entered the study; the mean age was 55.1 (16,58) years. The study duration was 28 days. Transdermal therapeutic system , fentanyl was used in opioid-naïve or pre-treated patients. Most patients reported a decrease in pain severity. Use of rescue medication decreased from day 4 to day 28. The majority of patients rated patch convenience of use as excellent. A total of 22.2% of patients experienced adverse events that were either probably related or very likely to be related to the study drug. The majority of the adverse events mentioned were related to the digestive system. Eighteen serious adverse events were reported by 13 patients. Six events were doubtfully related, and 12 events were not related to the study drug. Four patients died during the trial. None of these deaths was attributed to the study drug. In conclusion, the trial showed that TTS-F is easily managed, effective and will help to enable the appropriate opioid administration to patients who are suffering from cancer pain in Turkey. [source] Suboccipital Nerve Blocks for Suppression of Chronic Migraine: Safety, Efficacy, and Predictors of OutcomeHEADACHE, Issue 6 2010Silvia Weibelt RN (Headache 2010;50:1041-1044) Background., Approximately 1 in 50 Americans is afflicted by chronic migraine (CM). Many patients with CM describe cervicogenic headache. Options for treating CM effectively are at present quite limited. Objective., To determine the safety and efficacy of occipital nerve blocks (ONBs) used to treat cervicogenic chronic migraine (CCM) and to identify variables predictive of a positive treatment response. Methods., Using a uniform dose and injection paradigm, we performed ONBs consecutively on a series of patients presenting with CCM. Patients were stratified according to specific findings found to be present or absent on physical examination. A positive treatment outcome was defined as a 50% or greater reduction in headache days per month over the 30 days following treatment relative to the 30-day pre-treatment baseline. We used a 5-point Likert scale as one of the secondary outcome variables. Results., We treated 150 consecutive patients with unilateral (37) or bilateral (113) ONBs. At the 1-month follow-up visit 78 (52%) exhibited evidence of a positive treatment response according to the primary outcome variable, and 90 (60%) reported their headache disorder to be "better" (44; 29%) or "much better" (46; 30%). A total of 8 (5%) patients reported adverse events within the ensuing 72 hours, and 3 (2%) experienced adverse events that reversed spontaneously but required emergent evaluation and management. Conclusion., For suppression of CCM, ONBs may offer an attractive alternative to orally administered prophylactic therapy. [source] Tolerability and Safety of Frovatriptan With Short- and Long-term Use for Treatment of Migraine and in Comparison With SumatriptanHEADACHE, Issue 2002Gilles Géraud MD Objective.,To evaluate the tolerability and safety of frovatriptan 2.5 mg in patients with migraine. Background.,Frovatriptan is a new, selective serotonin agonist (triptan) developed for the acute treatment of migraine. Dose range-finding studies identified 2.5 mg as the dose that conferred the optimal combination of efficacy and tolerability. Methods.,The tolerability and safety of frovatriptan 2.5 mg were assessed during controlled, acute migraine treatment studies, including a study that compared frovatriptan 2.5 mg with sumatriptan 100 mg, as well as a 12-month open-label study during which patients could take up to three doses of frovatriptan 2.5 mg within a 24-hour period. Safety and tolerability were assessed through the collection of adverse events, monitoring of heart rate and blood pressure performance of 12-lead electrocardiogram, hematology screen, and blood chemistry studies. Results.,In the short-term studies, 1554 patients took frovatriptan 2.5 mg and 838 took placebo. In the 12-month study, 496 patients treated 13 878 migraine attacks. Frovatriptan was well tolerated in the short- and long-term studies with 1% of patients in the short-term studies and 5% of patients in the long-term study withdrawing due to lack of tolerability. The incidence of adverse events was higher in the frovatriptan-treated patients than in the patients who took placebo (47% versus 34%) and the spectrum of adverse events was similar. When compared to sumatriptan 100 mg, significantly fewer patients taking frovatriptan experienced adverse events (43% versus 36%; P=.03) and the number of adverse events was lower (0.62 versus 0.91), there were also fewer adverse events suggestive of cardiovascular symptoms in the frovatriptan group. Analysis of the entire clinical database (n=2392) demonstrated that frovatriptan was well tolerated by the patients regardless of their age, gender, race, concomitant medication, or the presence of cardiovascular risk factors. No effects of frovatriptan on heart rate, blood pressure, 12-lead electrocardiogram, hematology screen, or blood chemistry were observed. No patient suffered any treatment-related serious adverse event. Conclusions.,Short- and long-term use of frovatriptan 2.5 mg was well tolerated by a wide variety of patients. Frovatriptan treatment produced an adverse events profile similar to that of placebo, and in a direct comparison study was better tolerated than sumatriptan 100 mg. [source] Transvaginal Hysterosalpingo-Contrast Sonography (HyCoSy) Compared with ChromolaparoscopyJOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH (ELECTRONIC), Issue 1 2000Dr. Somchai Tanawattanacharoen Abstract Objective: To compare the efficacy and safety of HyCoSy with chromolaparoscopy for the diagnosis of tubal occlusion and uterine abnormalities. Methods: Sixty infertile women in whom the cause of infertility was thought to be tubal occlusion or uterine abnormalities and who satisfied the inclusion and exclusion criteria as specified in the study protocol were included. HyCoSy was performed during the first half of the menstrual cycle at least 24 hours prior to chromolaparoscopy. The results from both HyCoSy and chromolaparoscopy were compared in assessing tubal occlusion and uterine pathology. Results: For the evaluation of fallopian tubes, we found corresponding results between HyCoSy and chromolaparoscopy in 80.0%. The agreement between both procedures in assessing the uterine pathology was 80.4%. Twenty-two women experienced adverse events. The most common complaint was pelvic pain. Other events encountered were: nausea (3 women) and vaginal bleeding (2 women). All events were thought to be not related to the study drug. Conclusion: HyCoSy showed good diagnostic performance in the evaluation of the fallopian tubes and uterus in infertile women. The adverse events reported in this study are minor and procedure-related (catheter insertion) rather than the trial substance. [source] Original Article: Lignocaine gel in minimally invasive surgery , A pilot cohort studyAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 4 2010Natasha BEG Background:, The administration of local anaesthetic at the conclusion of minimally invasive procedures has been shown to reduce postoperative pain. However, it is often not feasible to reach target surgical sites using a needle, making it difficult to administer injectable local anaesthetic. Formulations currently available for topical use are also not sterile, adhere poorly, and are not adjusted to neutral pH at the time of use. To address these limitations, a new sterile, aqueous 4.8% lignocaine gel was formulated for topical application on surgical wounds. Aims:, To determine the clinical feasibility, safety and tolerability of the topical lignocaine gel. Methods:, A total of 125 female patients underwent minimally invasive gynaecological procedures. The lignocaine gel was applied to any intra-abdominal, intra-uterine or intra-vaginal surgical wounds. The incidence of any intra- or postoperative complications was determined via retrospective review of surgical reports, hospital files and outpatient clinic files. Results:, In all cases, the surgeon was able to apply the gel successfully to the desired site. There were no intra-operative complications. There were no adverse events encountered during recovery or hospitalisation which are likely to be associated with the lignocaine gel. Eight patients experienced adverse events during the postoperative period which could be linked to the use of the gel. However, the incidence of these was within the known range of adverse events for these procedures. Conclusions:, A sterile lignocaine gel can be safely used in minimally invasive surgery. [source] Treatment with short-term, high-dose cyclosporin A in children with refractory chronic idiopathic thrombocytopenic purpuraBRITISH JOURNAL OF HAEMATOLOGY, Issue 1 2003Silverio Perrotta Summary. We report on 14 children (seven boys, seven girls) with chronic idiopathic thrombocytopenic purpura (ITP) refractory to multiple treatments, who were given a short-term therapy (range between 6 and 10 weeks) with high doses of cyclosporin A (CyA) (median, 10 mg/kg/d). Six patients experienced adverse events and one developed severe systemic mycosis during therapy. A complete response (CR) was observed in four patients and a partial response (PR) in three patients. Only the four CR patients, who were all girls, had a sustained response. These data suggest that CyA may be effective in some children with chronic symptomatic ITP. [source] | ||||||||||