Due to early termination of OCR dosing, there was no formal primary end point analysis (change from baseline in modified total Sharp score (ΔmTSS) at week 104).
Factors that contributed to the lack of power are the small number of animals on test; a stop-exposure protocol for model rodent carcinogens; in a few cases, toxic doses that resulted in stoppage of dosing or termination of the experiment; and in a few cases, low doses administered to monkeys or early termination of the experiment even though the doses were not toxic.
In the worst case scenario, a toxicity related to the investigational medicinal product (IMP) may result in early termination of RT before a curative dose has been delivered, thus denying the patient the chance of tumour control.
Whereas data on dose reduction and early termination of treatment were collected in our study, we did not collect data on dose delay, as a variety of reasons could contribute to dose delay including patients' wish or public holidays, rather than related to toxicity.
Early termination of the study by patients in the highest dose group as per the IDMC recommendation after most of the patients had been dosed for 6 months offers a plausible explanation together with early withdrawals of symptomatic patients.
Other outcomes of interests were toxicity-related hospital admissions and proportions of patients requiring dose reduction or early termination of treatment.
Dose-limiting toxicities (DLT) are wound healing deficits or infections requiring surgical intervention, IORT-related cerebral bleeding or ischemia, symptomatic brain necrosis requiring surgical intervention and early termination of external beam radiotherapy (before the envisaged dose of 60 Gy) due to radiotoxicity.
To assess the efficacy, safety, and acceptability of early termination of pregnancy by vaginal administration of a single dose of misoprostol.
In spite of the early termination of the 150 mg arm, there remains a strong suggestion that the higher dose of atacicept was effective.
On July 19 , 2004 the independent Data Safety Monitoring Committee recommended early termination of the trial because of a significant mortality benefit in the cohort receiving fixed-dose ISDN-HYD.
