Table 4. Summary of secondary outcomes-participant disposition.
PARTICIPANT DISPOSITION | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
STUDY/YEAR | RANDOMIZED | COMPLETED STUDY FOLLOW UP | TOTAL LTFU (including withdrawal due to side effects) | LTFU (discontinued study for side effects only) | ANALYZED | |||||
INT | CNT | INT | CNT | INT | CNT | INT | CNT | INT | CNT | |
Baron 2015 | 159 | 154 | 133 | 126 | 26 | 28 | 17 | 16 | 157# | 152# |
Pota 2012 | 22 | 22 | 22 | 22 | 0 | 0 | 0 | 0 | 22 | 22 |
Sakai 2015 | 32 | 33 | 2 | 3 | 2 | 3 | 2 | 3 | 30 | 30 |
Kalita 2014 | 97 | 103 | 70 | 77 | 27 | 26 | 12 | 11 | 97# | 103# |
Romano 2009a | 42 in each treatment period | 36 in each treatment period | 6 in each treatment period | 4 in each treatment period | 36 in each treatment period | |||||
McCleane 2001 | 40 | 40 | 31 | 34 | 9 | 6 | Not provided | 31 | 34 | |
McCleane 2000b | 30 in each treatment period | 24 in each treatment period | 6 in each treatment period | 1 | 0 | 24 in each treatment period | ||||
Atkinson 2016 | 55 | 53 | 36 | 36 | 19 | 17 | 12 | 6 | 36 | 36 |
CNT, Control; INT, Intervention; LTFU, Loss to follow-up
a= triple arm crossover study;
b=crossover study;
#=performed intent to treat analysis by imputing for patients lost to follow up.