Efficacy and Safety of CVT-E002, a Proprietary Extract of Panax quinquefolius in the Prevention of Respiratory Infections in Influenza-Vaccinated Community-Dwelling Adults: A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Trial
Table 4
Incidence of adverse events and serious adverse events among different groups.
Treatment group
valuea
Placebo ()
CVT-E002-400 ()
CVT-E002-800 ()
Adverse events
Total number of adverse events
215
220
216
Any adverse event
117 (46.3%)
122 (49.0%)
119 (48.4%)
0.811
Adverse event by category
Allergy
2 (0.8%)
0 (0.0%)
2 (0.8%)
0.478
Blood
1 (0.4%)
0 (0.0%)
0 (0.0%)
>0.999
Cardiovascular
17 (6.7%)
6 (2.4%)
9 (3.7%)
0.049
Constitutional
7 (2.8%)
8 (3.2%)
10 (4.1%)
0.715
Dermatology
12 (4.7%)
17 (6.8%)
10 (4.1%)
0.353
Endocrine
0 (0.0%)
2 (0.8%)
1 (0.4%)
0.328
Gastrointestinal
42 (16.6%)
30 (12.1%)
40 (16.3%)
0.284
Hemorrhage
1 (0.4%)
4 (1.6%)
3 (1.2%)
0.375
Infection
5 (2.0%)
5 (2.0%)
3 (1.2%)
0.828
Metabolic
0 (0.0%)
2 (0.8%)
0 (0.0%)
0.218
Musculoskeletal
8 (3.2%)
14 (5.6%)
6 (2.4%)
0.147
Neurology
10 (4.0%)
11 (4.4%)
15 (6.1%)
0.502
Ocular
1 (0.4%)
2 (0.8%)
2 (0.8%)
0.750
Oncology
1 (0.4%)
0 (0.0%)
2 (0.8%)
0.437
Otic
1 (0.4%)
1 (0.4%)
3 (1.2%)
0.461
Pain
28 (11.1%)
27 (10.8%)
24 (9.8%)
0.879
Pulmonary
32 (12.7%)
34 (13.7%)
34 (13.8%)
0.917
Renal/genitourinary
5 (2.0%)
8 (3.2%)
4 (1.6%)
0.460
Serious adverse events
Total number of serious adverse events
13
14
10
Any serious adverse event
12 (4.7%)
14 (5.6.0%)
10 (4.1%)
0.719
Serious adverse event by category
Cardiovascular
4 (1.6%)
4 (1.6%)
2 (0.8%)
0.784
Dermatology
0 (0.0%)
0 (0.0%)
1 (0.4%)
0.329
Gastrointestinal
5 (2.0%)
3 (1.2%)
2 (0.8%)
0.623
Hemorrhage
0 (0.0%)
0 (0.0%)
1 (0.4%)
0.329
Infection
0 (0.0%)
1 (0.4%)
0 (0.0%)
0.662
Musculoskeletal
1 (0.4%)
2 (0.8%)
1 (0.4%)
0.849
Neurology
1 (0.4%)
2 (0.8%)
0 (0.0%)
0.550
Oncology
1 (0.4%)
0 (0.0%)
0 (0.0%)
>0.999
Pain
1 (0.4%)
0 (0.0%)
1 (0.4%)
0.775
Pulmonary
0 (0.0%)
1 (0.4%)
0 (0.0%)
0.662
Renal/genitourinary
0 (0.0%)
1 (0.4%)
2 (0.8%)
0.218
aWhen 50% of the cells have expected cell counts less than 5 Fisher’s exact two tailed test was used. Otherwise, comparisons made using chi-square test for comparing proportions.