Reasons for treatment discontinuation were disease progression (33%), AEs (33%), and others (34%, including withdrawal of consent and investigator request).
We conduct internal quality assurance audits of ongoing trials, initiated either by random selection, investigator request, or in response to specific events or concerns.
Twelve (5%) and 34 (14%) patients discontinued treatment because of disease progression or death in the bosutinib and imatinib arms; 80 (32%) and 38 (15%) discontinued for other reasons (adverse events, patient request, investigator request, protocol violation, failure to return, lost to follow-up and other).
Of the 297 with no 1-year data, 239 had no follow-up information available within the time window and 58 withdrew before 1-year data were collected, because of participant request (n = 13), lost to follow-up (n = 15), death (n = 14), investigator request (n = 2) and other (n = 14).
This combination was further evaluated at the MTD in part 2. Treatment summaries for parts 1 and 2 are shown in Table 2. Overall, 90 patients discontinued treatment; reasons for stopping treatment included disease progression (n=75 (68%)), patient request (n=7 (6%)), death (n=3 (3%)), adverse event (n=2 (2%)), investigator request (n=2 (2%)), and other (n=1 (1%)).
In the ≥65 y age group, from 137 enrolled subjects (site 1, n = 68; site 2, n = 69), 3 were withdrawn (1 at investigator request before vaccination, 1 was lost to follow-up, and 1 did not have postvaccination blood drawn within the prescribed time windows) and were not included in the evaluable immunogenicity population (n = 134).
When they're working, switched on and pointing the right way, footage is often "scrubbed" before an investigator requests it, because storage is expensive.
But Cameron asks: "How would you feel if an affair were disclosed to your significant other after a private investigator requested your driving record from Microdesign's Electronic Toll Collection database?
The Principal Investigator requested and obtained a waiver of requiring a signed consent from each participant in the study.
Five potential participants also sent an email directly to the primary investigator requesting a copy of the questionnaire.
This was one of the key reasons for adopting a model in which an investigator requested the raw sequence data related to their research expertise and passion.
