Issues Summary: Potential major issue(s) detected - see table below
Trial-Related Publications: n/a
TIMELINE & ANALYSIS OF CHANGES TO THIS TRIAL'S RECORD
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|Rec||4||4||-||-||-||-||-||Anticipated primary completion date (Dec 2013) may be unfeasible given current status (recruiting) and primary endpoint time frame (6 months post-treatment)|
|Rec||4||4||-||-||-||-||-||Primary completion date extended ex post facto. First extension of primary completion date, totalling 2+ years|
|NOTE: As of today (Dec 11, 2018) this trial’s record has not been updated by the sponsor in 4+ years. The trial’s current status is therefore questionable.|
|* Status abbreviations:|
|NYR:||not yet recruiting||Sus:||suspended|
|ANR:||active, not recruiting||Unk:||unknown|
** Flags are assigned by our automated analysis to indicate the relative potential of each recorded change to suggest a possible set-back or problem for the trial. They are intended as aids to the scanning of these records, not as predictions regarding the success or failure of a clinical trial.
Potentially minor negative implications for this change
Potentially significant negative implications for this change
n/a: Flags are not assigned to changes dated subsequent to trial completion or termination.
Examples of events that may be viewed as having potentially negative implications include (but are not limited to):
- Suspension of a trial
- No record updates for > 1 year
- Inclusion late in a trial of an additional patient cohort with much less severe disease
- Significant liberalization of inclusion/exclusion criteria late in a trial
- Unusually slow rate of progression of trial sites status from "Not yet recruiting" to "Recruiting"
- Significant over-run of Estimated Primary Completion Date
- Termination or deletion of a significant fraction of trial sites