Adverse events patient reporting

Ezetimibe 1 0 mg tablet 10 mg once daily The overall incidence of adverse events reported with ezetimibe alone was similar to that reported with placebo and generally similar between ezetimibe with a statin and statin alone. The frequency of increased transaminases was slightly higher in patients receiving ezetimibe plus a statin compared with those receiving statin monotherapy (1.3% versus 0.4%). 

The Important Role of Pharmacists in a Complex Risk-Management System Managing the Risks from Medical Product Use by Focusing on Patient Education, Monitoring, and Adverse Event Reporting... 

The Parties agree to adhere to the principles of medical confidentiality in relation to Clinical Trial Subjects involved in the Clinical Trial. Personal data shall not be disclosed to the Sponsor by the NHS Trust save where this is required directly or indirectly to satisfy the requirements of the Protocol or for the purpose of monitoring or adverse event reporting. The Sponsor shall not disclose the identity of Clinical Trial Subjects to third parties without prior written consent of the Clinical Trial Subject, in accordance with the requirements of the Data Protection Act 1998 and the principles set out in the Report of the Caldicott Committee on the review of patient identifiable information dated December 1997, a copy of which the NHS Trust shall supply to the Sponsor on request. 

The most frequently reported serious adverse events reported with cancer chemotherapy patients included death, fever, pneumonia, dehydration, vomiting, and dyspnea. The most commonly reported adverse events were fatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea. The most frequently reported reasons for discontinuation of darbepoetin alfa were progressive disease, death, discontinuation of the chemotherapy, asthenia, dyspnea, pneumonia, Gl hemorrhage, thrombotic events, rash, dehydration. 

The three most common adverse events reported by patients receiving 20 mg trospium twice daily were dry mouth, constipation, and headache. 

Eszopiclone has been approved for the treatment of patients who experience difficulty falling asleep, poor sleep maintenance, and for long-term treatment of insomnia. Clinical trials have shown that eszopiclone improved sleep onset, sleep maintenance, total sleep time, sleep quality, and daytime functioning compared with placebo. Improved wake time alertness, concentration, and sense of well-being were reported. Eszopiclone was well tolerated, with only mild adverse events reported. There was no evidence of dmg-drug interactions, tolerance, residual drowsiness or treatment-related rebound insomnia. The recommended dose to improve sleep onset and maintenance is generally between 1 and 3 mg. 

Published case reports on alprazolam show a slightly different profile (266, 267, 268 and 269). Four patients had taken the drug for 4.5 months or less one had also taken chlorpromazine and trazodone and a fifth patient had taken alprazolam (3 mg/day for 26 weeks) and phenelzine (45 mg/day for 13 weeks), abruptly stopping both. According to the FDA s Spontaneous Adverse Event Reporting System, more seizures have been reported with alprazolam than with all other BZDs combined (270). The next highest incidence was reported for lorazepam. The FDA report stated the following ... 

On the other hand, a number of adverse event reports recorded in the literature are themselves erroneous in nature due to the quality of the assessment and reporting, with Siegel s report of the so-called ginseng-abuse-syndrome (GAS) being a prime example (24). In this report, the author simply recorded adverse reactions in patients who had ingested ginseng without reference to which of a number of plants having the same common... 

Of 206 postmenopausal women who took the oral combination of estradiol valerate plus norethisterone (5) eight withdrew because of bleeding during year 1 during years 2 and 3 there were no withdrawals because of bleeding. By the end of year 3, 133 patients had completed the study. There were serious adverse effects in 24, but there was no definite relation to therapy. The numbers of adverse events reported each year by the patients who completed the study are shown in Table 1. The authors concluded that this combination was effective in the majority of patients and was well tolerated. 

Adverse Events You should provide each adverse event report as a separate PDF file in a subfolder labeled Adverse Events. To aid Center staff in identifying each PDF file, please use a combination of the protocol number, patient number, and event date in each file name (e.g., RIT-02-004 010-023 07132001). Within the Adverse Events subfolder, you should provide a PDF file named adverse eventsctoc.pdf (i.e., adverse events cumulative TOC). The adverse eventsctocpdf is a cumulative list of all adverse events that occurred during the clinical investigation. The cumulative list should be in inverse chronological order with the most recent submission at the top of the list. Because this... 

In an open study 25 patients with new-onset focal and primary generalized epilepsy were treated with clobazam at a single centre (2). After a mean follow-up of 16 months (range 7-24), 16 patients were seizure free, while five had more than a 50% reduction in seizure frequency. Sedation was the most common adverse event, reported by four patients however it was always mild and did not require withdrawal of clobazam. Other adverse effects, reported in one patient each, were weight gain, ataxia, loss of shortterm memory, and breakthrough seizures. 

Systemic adverse events reported in approximately 10% of patients are infections (primarily colds and upper respiratory tract infections). Systemic adverse events reported in approximately 1% to 5% of patients include headaches, asthenia, and hirsutism. 

The most frequent adverse event reported with ketorolac use is transient stinging and burning after instillation of the ophthalmic solution. Rarely, allergic reactions and superficial keratitis have occurred. Although inconsistent cases of corneal toxicity have been reported with NSAIDs, prolonged use of NSAIDs in a select group of patients showed the potential for corneal melt. Because other treatment options exist for allergic eye disease, NSAIDs do not need to be used in patients with compromised corneas or those at risk for potentially serious adverse corneal reactions. 

The majority of gemifloxacin adverse reactions experienced by patients in clinical trials were considered to be of mild to moderate severity, primarily due to rash (0.8% of patients), nausea (0.3%), diarrhea (0.3%), urticaria (0.2%), and vomiting (0.2%). Most of the postmarketing adverse events reported were cutaneous and most of these were rash. Some of these cutaneous adverse events were considered serious. The majority of rashes occurred in women and in patients under 40 years of age. 

In a prospective efficacy trial of atovaquone suspension (750 mg od or 250 mg tds for 1 year) in P. jiroveci prophylaxis in 28 liver transplant recipients intolerant of co-trimoxazole, the adverse events reported included diarrhea (n — 7) and bloating or abdominal pain (n — 3) (16). No patient had developed P. jiroveci pneumonia by 37 months. This is a smaller dose than approved for Pneumocystis prophylaxis in HIV infection (1500 mg/day). Further studies in recipients of solid organ transplants are needed to confirm the efficacy of this prophylactic dose. 

Data from 20 clinical studies in 5000 patients who had taken ranitidine bismuth citrate (200, 400, or 800 mg bd) have been reported (14). The incidence of adverse events was not different from that associated with placebo and was independent of dose. The most common events (>1% of patients) were upper respiratory tract infections, constipation, diarrhea, nausea, vomiting, dizziness, and headache, the last being the only event reported by over 2% of the patients. Adverse events considered by the chnical investigator to be adverse reactions occurred with a similar frequency amongst patients given ranitidine bismuth citrate (8%), ranitidine hydrochloride (6%), and placebo (6%). The incidence of adverse reactions was greater when amoxicillin (11%) or clarithromycin (20%) were co-prescribed. 

Information about this topic comes from the two large studies, CLASS and VIGOR, from a pooled cardiovascular safety analysis using individual patient data derived from all rofecoxib phase Ilb to V trials conducted by the manufacturer that lasted at least 2 weeks, and from the adverse events reporting system in the USA (34). As a result of these and other studies the COX-2 inhibitors, rofecoxib and valdecoxib, have been voluntarily withdrawn from the market by their manufacturers, and other COX-2 inhibitors are under scrutiny. 

Adverse events after hepatitis B vaccine reported between 1 January 1991 and 31 May 1995 to the US Vaccine Adverse Events Reporting System have been reviewed (6). The patients included 58 neonates and 192 infants who were immunized with hepatitis B... 

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