a An additional two patients were enrolled in the 20 mg OD cohort but were withdrawn prior to receiving AZD3965.
b Two events of Grade 3 increased cardiac troponin I were reported for the same patient.
c ERG change DLTs were reported as AEs of retinopathy or eye disorders – other (ERG changes). All were Grade 1. One event was reported as Grade 2 but it was later confirmed by the Chief Investigator (Principal Investigator at the site) that this should have been recorded as Grade 1 since the patient was asymptomatic and had no change in visual acuity
d The DLT of Grade 3 acidosis occurred after the single dosing day of 20 mg OD at D-7; the patient was withdrawn from the trial prior to commencing daily dosing at 10 mg BD.
Abbreviations: BD, twice daily; DLT, dose limiting toxicity; ERG, electroretinogram; OD, once daily.