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Table 4 Summary of serious adverse events (safety population)

From: Safety and tolerability of donepezil 23 mg with or without intermediate dose titration in patients with Alzheimer’s disease taking donepezil 10 mg: a multicenter, randomized, open-label, parallel-design, three-arm, prospective trial

Subject Age Sex Study group Event Sx. onset (after study initiation) Relationship to study drug Seriousness Dropout
1 78 F Group 1 Acute cerebral infarct 41 days Not related Severe no
2 78 M Group 1 Diabetic foot 27 days Not related Moderate no
3 76 M Group 1 1st seizure (post-stroke) 2 days Not related Moderate yes
4 85 F Group 2 Fall 47 days Not related Mild yes
5 68 M Group 2 Unruptured cerebral aneurysm 25 days Not related Mild no
6 76 F Group 2 Dizziness, facial bone fx. 11 days Probably related Moderate yes
7 78 M Group 2 Inguinal hernia 2 days Not related Moderate no
8 56 F Group 3 Lumber sprain 40 days Not related Mild no
9 77 F Group 3 Influenza A, APN, gastroenteritis 47 days Not related Moderate no
10 81 F Group 3 Femur fx. after slip down 14 days Not related Moderate no
11 78 F Group 3 Nausea, vomiting, chilling 0 day Possibly related Severe yes
  1. Relationships between the study drug and AEs were rated as unrelated, possibly related, or probably related