Table 1 Subject disposition
Placebo | Grass AIT | |
|---|---|---|
N (%) | N (%) | |
Full analysis set (FAS) | 166 (100%) | 163 (100%) |
Per protocol (PP) | 119 (72%) | 121 (74%) |
Subjects with diary data (entire GPS) | 150 (90%) | 139 (85%) |
Subjects with diary data (peak GPS) | 143 (86%) | 137 (84%) |
Withdrawn from trial | 26 (16%) | 27 (17%) |
Reason for withdrawal | ||
Withdrawal of consent | 7 (4%) | 8 (5%) |
Lost to follow-up | 5 (3%) | 2 (1%) |
Non-compliance with protocol | 3 (2%) | 1 (<1%) |
Pregnancy | 2 (1%) | 0 (0%) |
Adverse event | 5 (3%) | 10 (6%) |
Other | 4 (2%) | 6 (4%) |
Withdrawal initiated by | ||
Investigator | 6 (4%) | 7 (4%) |
Sponsor | 1 (<1%) | 0 (0%) |
Subject | 19 (11%) | 20 (12%) |
Completed | 140 (84%) | 136 (83%) |