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Terminating the study with a lesser number of patients was communicated to the Institutional Review Board.
Subsequently, after terminating the study, we found that the DNA ploidy results differed in the specimens in approximately one-fourth of the cases [ 30].
In metastatic neuroendocrine tumors 207 (Table 3, BM), adverse events were ventricular tachycardia and prolonged QT, possibly resulting in a sudden death, terminating the study prematurely.
The investigators do not expect any serious adverse events that will require an interim analysis to make a deliberate consideration of terminating the study earlier than planned (approved by the institutional ethics committee).
Of those patients terminating the study before week 24, only two in the IFN-β-1a arm and one in the placebo arm left the study secondary to adverse events.
Overall, the study was prematurely terminated due to AEs by 60 patients (7.3%), with 8.2% of children and 5.0% of adolescents terminating the study due to AEs (p = 0.144).
Similar(50)
The researcher may or may not decide to terminate the study.
There was, however, no intention in the Public Health Service to terminate the study, and this was not, strictly speaking, a secret study.
Since patient recruitment was slower than expected, the sponsor decided to terminate the study at the interims analysis, and no further patients were enrolled.
No subject terminated the study early or complained about side-effects apart from unpleasantness or mild pain upon nasal insufflation of CO2.
The participant was happy to continue after eating 36, but the decision was made to terminate the study for his own safety.
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