Review by Joseph Ross – 06/02/2015 – 12:49pm

Data Request Number: 2015-0500 Recommendation for this data request: Not Approve

Further clarifications are needed to enhance the readability of the proposal:

Please clarify in the Introduction whether the prior research that identified several drugs (dexamethasone, metoprolol, clopidogrel, oxycodone, and citalopram) used among CRPC patients that placed patients at risk for potentially risky DDI were because of each of the drugs interacting with Abiraterone or because the drugs interact with one another.

Six main outcome measures are discussed, but not all are clearly defined. In particular, how will adverse events be defined? The explanation given (“Postulated DDI are called if the patient experiences an adverse event grade ≥2 (CTCAEv3.0) that was predicted by the DDI database screen.”) is not clear as written.

It would be ideal if fewer abbreviations were used (for instance, why abbreviate Abiraterone as AA? Each is one word).