scholarly journals A prospective evaluation of tolerability of niraparib dosing based upon baseline body weight (wt) and platelet (blplt) count: Blinded pooled interim safety data from the PRIMA Study

2018 ◽  
Vol 29 ◽  
pp. viii335-viii336 ◽  
Author(s):  
A. Gonzalez ◽  
M.R. Mirza ◽  
I. Vergote ◽  
Y. Li ◽  
S. Hazard ◽  
...  
2000 ◽  
Vol 4 (2) ◽  
pp. 66-70 ◽  
Author(s):  
Peter R. Hull ◽  
Coby Demkiw-Bartel

Background: Isotretinoin is an effective treatment for severe acne. Although the spectrum of side effects has been well documented, the changing incidence of such side effects over the course of treatment has not been studied in detail. Objectives: The purpose of our study was to examine a group of patients monthly over their course of treatment and prospectively document the side effects experienced. Methods: Over the period between January 1991 and July 1996, 124 courses of treatment with isotretinoin for severe acne were followed. The patients were treated for 4 months at a dose of 1 mg per kg body weight. A questionnaire was administered monthly, inquiring specifically about side effects known to be associated with isotretinoin. Any additional side effects were also noted. Results: The majority of patients experienced persistent dryness of lips. Dry eyes affected 40% of patients; this continued throughout treatment in 25%. Contact lens wearers were more likely to develop conjunctivitis. Lower back pain was reported early in about 30% of patients and fewer than 10% of patients would develop it later in the course of treatment. Arthralgia was noted in 16.5% of patients at the first visit and there was little change with ongoing treatment. Hair loss was experienced in a small percentage but was rarely noted on more than one occasion. Headaches occurred in less than 10% and were occasionally severe, but most often intermittent and recorded at a single visit. Depression occurred in 4% of patients and tended to persist throughout the treatment. All these patients completed the full course of treatment. Conclusion: This prospective analysis has shown that patients treated with isotretinoin experienced a predictable series of side effects. Some occurred fleetingly, but several persisted for the duration of treatment.


Scientifica ◽  
2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Khalid Ghazanfar ◽  
Showkat Ahmad Dar ◽  
Seema Akbar ◽  
Tazeen Nazir ◽  
Mariya Hamdani ◽  
...  

Capsule Shaqeeqa, Unani formulation, is prescribed for the clinical treatment of diseases like sinusitis, headache, and migraine. The safety evaluation data of it is not available; in order to provide the safety data the present study was carried out. The study was carried out on four groups of rats (n=5). Two groups (one male and one female group) as normal controls were orally given water while the other two groups were orally given daily doses of drug at the dose level of 150 mg/kg of body weight for duration of 90 days. Physiological parameters like body weight, feed consumption, water consumption, and clinical signs were regularly monitored and recorded. Organs were collected, examined, and weighed and specimens were taken for histopathological studies. The results showed that the drug did not alter the physiological parameters. There was no mortality or any morbidity found in drug treated rats. There was no statistical significant change found in any haematological or biochemical parameter of rats orally fed with Shaqeeqa. A statistically insignificant association verified that haematological and biochemical parameters were rendered unaffected by the drug. Moreover histological investigations of essential key organs demonstrated that the drug did not prompt any histopathological change. These observations demonstrate the safety of Capsule Shaqeeqa at the studied dosage levels.


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