Table 4.

Reported forms of departure from treatment protocol

	Number (%)
Reported some form of nonadherence to treatment protocola	98
Participants who did not initiate allocated treatment	39
Participants with incomplete treatment (among those who initiated allocated treatment)	78
Participants who switched trial treatments	12
Participants who started open label treatment (not as per protocol)	7
Participants who started disallowed or non-trial treatment	4
Evidence of contamination between treatment groups	3
Other forms of nonadherence to treatment dose or schedule	23
Nonadherence on the part of treatment providers	12
Did not report any nonadherence to treatment protocol	2
Percentage of patients experiencing or displaying some form of nonadherence to treatment protocol
None reported	2
0 to 5%	23
5 to 10%	10
10 to 20%	22
20 to 30%	11
30 to 50%	12
>50%	9
>0% but unclearb	11

^aTrial publications may have reported the number of participants in more than one of the categories listed. ^bFor example, trial report states only that the treatment providers were not adherent to some degree, or it was not possible to distinguish withdrawal from treatment for legitimate reasons (for example, death or treatment changes permitted by protocol following adverse events) from withdrawal due to nonadherence.