Table 2 Amendments to date
List of amendments | Summary of change |
|---|---|
SA01 14/09/2016 | • Personnel randomising to the trial has changed from pharmacy to research members as the randomisation software allows randomisation while protecting the blind • Minor change to inclusion criteria – removed ‘modified RECIST’ from measurable disease section |
SA02 25/01/2017 | • Change to eligibility criteria – removed ‘measurable disease on CT (tumour thickness > 5 mm)’ • Dr. Steve Walker added as sub-investigator • Radiological data collection is further explained in section 5.13 • Plan of analysis (Section 6.1) details how the radiological information will be used to calculate the sample size for the full study |
SA03 26/04/2017 | • Addition of Patient appointment schedule v1.0 22/03/17 |
SA04 08/09/2017 | • Request to interview patients who decline participation in the trial • Clarify number of patients for semi-structured interview (up to data saturation rather than the previously stated 10) |
NSA01 20/09/2017 | • Extend recruitment period by 1 month, to November 2017 |