Clinical Study

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 events215220216
Any adverse event117 (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
 Blood1 (0.4%)0 (0.0%)0 (0.0%)>0.999
 Cardiovascular17 (6.7%)6 (2.4%)9 (3.7%)0.049
 Constitutional7 (2.8%)8 (3.2%)10 (4.1%)0.715
 Dermatology12 (4.7%)17 (6.8%)10 (4.1%)0.353
 Endocrine0 (0.0%)2 (0.8%)1 (0.4%)0.328
 Gastrointestinal42 (16.6%)30 (12.1%)40 (16.3%)0.284
 Hemorrhage1 (0.4%)4 (1.6%)3 (1.2%)0.375
 Infection5 (2.0%)5 (2.0%)3 (1.2%)0.828
 Metabolic0 (0.0%)2 (0.8%)0 (0.0%)0.218
 Musculoskeletal8 (3.2%)14 (5.6%)6 (2.4%)0.147
 Neurology10 (4.0%)11 (4.4%)15 (6.1%)0.502
 Ocular1 (0.4%)2 (0.8%)2 (0.8%)0.750
 Oncology1 (0.4%)0 (0.0%)2 (0.8%)0.437
 Otic1 (0.4%)1 (0.4%)3 (1.2%)0.461
 Pain28 (11.1%)27 (10.8%)24 (9.8%)0.879
 Pulmonary32 (12.7%)34 (13.7%)34 (13.8%)0.917
 Renal/genitourinary5 (2.0%)8 (3.2%)4 (1.6%)0.460

Serious adverse events
Total number of serious adverse events131410
Any serious adverse event12 (4.7%)14 (5.6.0%)10 (4.1%)0.719
Serious adverse event by category
 Cardiovascular4 (1.6%)4 (1.6%)2 (0.8%)0.784
 Dermatology0 (0.0%)0 (0.0%)1 (0.4%)0.329
 Gastrointestinal5 (2.0%)3 (1.2%)2 (0.8%)0.623
 Hemorrhage0 (0.0%)0 (0.0%)1 (0.4%)0.329
 Infection0 (0.0%)1 (0.4%)0 (0.0%)0.662
 Musculoskeletal1 (0.4%)2 (0.8%)1 (0.4%)0.849
 Neurology1 (0.4%)2 (0.8%)0 (0.0%)0.550
 Oncology1 (0.4%)0 (0.0%)0 (0.0%)>0.999
 Pain1 (0.4%)0 (0.0%)1 (0.4%)0.775
 Pulmonary0 (0.0%)1 (0.4%)0 (0.0%)0.662
 Renal/genitourinary0 (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.