Serious unexpected suspected adverse drug

SUSAR Serious unexpected suspected adverse drug reaction ... 

In clinical trials of IMPs without a MA, sponsors must report all serious unexpected suspected adverse drug reactions (SUSARs) within eight calendar days if they were fatal or life threatening, and within fifteen days for other serious cases. The initial report has to be followed up within seven days for fatal or life-threatening cases and within fifteen days for other serious reports. These expedited reporting requirements mean that the treatment code in blinded trials must be broken, as it is otherwise impossible to decide which treatment the patient received and, therefore, impossible to determine whether an event could possibly be a reaction if a patient received placebo, then there is no suspicion of a possible adverse reaction to the IMP and authorities do not require expedited... 

CIOMS IV form for reporting of serious unexpected suspected adverse drug reactions www.cioms.ch. ABPI Code of Practice 2003. 

During the clinical trial phase of development, there is a major safety focus on the protection of trial subjects. Investigators are obliged to document and report serious adverse events promptly. If serious, unexpected and suspected to be related to the drug (this is known as a SUSAR - see Chapter 5), then a case should be unblinded and reported to regulatory authorities. The identification... 

The safety and efficacy of oral cyclodextrin itraconazole (5 mg/kg/day) as antifungal prophylaxis has been assessed in an open trial in 103 neutropenic children (median age 5 years range 0-15 years) (53). Prophylaxis was started at least 7 days before the onset of neutropenia and continued until neutrophil recovery. Of the 103 patients, only 47 completed the course of prophylaxis 27 withdrew because of poor compliance, 19 because of adverse events, and 10 for other reasons. Serious adverse events (other than death) occurred in 21 patients, including convulsions (n = 7), suspected drug interactions (n = 6), abdominal pain (n — 4), and constipation n — 4). The most common adverse events considered definitely or possibly related to itraconazole were vomiting (n = 12), abnormal liver function (n — 5), and abdominal pain (n = 3). Tolerabihty of the study medication at end-point was rated as good (55%), moderate (11%), poor (17%), or unacceptable (17%). There were no unexpected problems of safety or tolerability. 

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