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Table 3 Overall summary of treatment-emergent adverse events (TEAE) by severity: safety set population

From: Efficacy and safety of GV1001 in patients with moderate-to-severe Alzheimer’s disease already receiving donepezil: a phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial

All TEAEs

Placebo

(group 1)

(n = 31)

GV1001 0.56 mg

(group 2)

(n = 32)

GV1001 1.12 mg

(group 3)

(n = 32)

Overall

(n = 95)

P value

n (%)

Events

n (%)

Events

n (%)

Events

n (%)

Events

 

Mild

12 (38.7)

32

13 (40.6)

33

10 (31.3)

28

35 (36.8)

93

0.714a

Moderate

2 (6.5)

4

5 (15.6)

7

5 (15.6)

10

12 (12.6)

21

0.451a

Severe

2 (6.5)

2

0 (0.0)

0

0 (0.0)

0

2 (2.1)

2

0.104b

  1. Note: study group 1 = placebo (control); study group 2 = GV1001 0.56 mg; study group 3 = GV1001 1.12 mg
  2. Abbreviations: TEAE treatment-emergent adverse event, n number of patients
  3. aChi-square test; bFisher’s exact test
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Alzheimer's Research & Therapy

ISSN: 1758-9193