Table 2. Adverse events by formulation.
Overall Events | Severity | Overall | RF TFV | RGVF TFV | VF TFV | ||||
---|---|---|---|---|---|---|---|---|---|
N | % | N | % | N | % | N | % | ||
Grade 1 | 25 | 86.21 | 7 | 100.00 | 7 | 87.50 | 11 | 78.57 | |
Grade 2 | 2 | 6.90 | 0 | 0.00 | 1 | 12.50 | 1 | 7.14 | |
Grade 3 | 2 | 6.90 | 0 | 0.00 | 0 | 0.00 | 2 | 14.29 | |
Total | 29 | 100 | 7 | 100 | 8 | 100 | 14 | 100 | |
Overall Events By System | |||||||||
Gastrointestinal | Grade 1—Mild | 17 | 94.44 | 5 | 100 | 5 | 83.33 | 7 | 100 |
Gastrointestinal | Grade 2—Moderate | 1 | 5.56 | 0 | 0.00 | 1 | 16.67 | 0 | 0.00 |
Total | 18 | 100 | 5 | 100 | 6 | 100 | 7 | 100 | |
Genitourinary | Grade 2—Moderate | 1 | 33.33 | 0 | 0.00 | 0 | 0.00 | 1 | 33.33 |
Genitourinary | Grade 3—Severe | 2 | 66.67 | 0 | 0.00 | 0 | 0.00 | 2 | 66.67 |
Total | 3 | 100 | 0 | 0.00 | 0 | 0.00 | 3 | 100 | |
HEENT | Grade 1—Mild | 2 | 100 | 0 | 0.00 | 2 | 100 | 0 | 0.00 |
Total | 2 | 100 | 0 | 0.00 | 2 | 0.00 | 0 | 0.00 | |
Neurological | Grade 1—Mild | 5 | 100 | 2 | 100 | 0 | 0.00 | 3 | 100 |
Total | 5 | 100 | 2 | 100 | 0 | 0.00 | 3 | 100 | |
Respiratory | Grade 1—Mild | 1 | 100 | 0 | 0.00 | 0 | 0.00 | 1 | 100 |
Total | 1 | 100 | 0 | 0.00 | 0 | 0.00 | 1 | 100 | |
Proportion of participants with≥ Grade 2 adverse events | 0 | 0.00 | 1 | 7.69 | 1 | 7.69 |