| |
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Withdrawn from trial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%)
|
- 9 of the subjects with data in the grass pollen season dropped out before the peak grass pollen season and thus did not provide any data in the peak grass pollen season.
- % = percentage of the full analysis set (all randomized subjects). AIT Allergy immunotherapy tablet, GPS Grass pollen season.
