|
Yes, conduct of recruitment
|
10 (18%)
|
|
Inclusion criteria widened
|
2 (20%)
|
|
Increased number of sites
|
2 (20%)
|
|
The predicted recruitment rate for the rest of the trial was amended
|
1 (10%)
|
|
Recruitment extended for the main trial
|
1 (10%)
|
|
Reduced the number of arms in the trial and the sample size
|
1 (10%)
|
|
TSC recommended sample size re-estimation given observed complication rate difference
|
1 (10%)
|
|
Simplified of inclusion/exclusion criteria; shortened of case report forms
|
1 (10%)
|
|
Widened inclusion criteria; increased number of sites
|
1 (10%)
|
|
Yes, impact on outcome data
|
1 (2%)
|
|
Clarifications made to the protocol; flexibility added to location of outcome assessments
|
1 (100%)
|
|
Yes, in terms of both recruitment and outcome data
|
1 (2%)
|
|
Change of eligibility criteria; change to secondary outcomes; inclusion of a sub-trial
|
1 (100%)
|
|
Yes, no further information given
|
2 (4%)
|
|
No
|
43 (75%)
|
|
Total
|
57 (100%)
|
