Safety of co-prescribed injectable heroin treatment

8A.1 Focus of the evaluation

To evaluate the medical safety of co-prescription of injectable heroin in the present trial, all clinically significant adverse events (AEs), serious adverse events (SAEs) and unexpected adverse events were documented by the treating physician on a continuous basis during the trial. Adverse events and serious adverse events were defined, registered and reported in accordance with the ICH/EU guidelines. In addition, drug overdoses, psychoses and (epileptic) seizures were documented separately throughout the trial.

For the purpose of the present report, the evaluation of the medical safety of co-prescribed heroin focussed on the occurrence of SAEs, and separately on the occurrence of drug overdoses, psychoses and seizures. Other types of AEs were not included in the present evaluation. The observation period used for the evaluation was limited to the experimental treatment phase of the trial, i.e. the first twelve months following randomization. The evaluation was limited to the intention-to-treat population (n=174).
An additional safety topic concerned the evaluation of SAEs, drug overdoses, psychoses and (epileptic) seizures following the discontinuation of co-prescribed heroin treatment at the end of the experimental treatment phase. This evaluation was limited to the patients who had received and completed the experimental treatment with co-prescribed heroin (i.e. the treatment completers in group B). The observation period of this - separate - evaluation concerned the two months following the discontinuation of the co-prescribed heroin treatment (i.e. before a possible reinstatement of the heroin treatment in phase III; see paragraph 2.2.1).