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Table 1 Subject disposition

From: A phase 3 trial assessing the efficacy and safety of grass allergy immunotherapy tablet in subjects with grass pollen-induced allergic rhinitis with or without conjunctivitis, with or without asthma

  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Withdrawn from trial 26 (16%) 27 (17%)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%)
  1. 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.
  2. % = percentage of the full analysis set (all randomized subjects). AIT Allergy immunotherapy tablet, GPS Grass pollen season.