Table 2.
Solicited adverse events
|
Group 1 (n=5) |
Group 2 (n=5) |
Group 3 (n=5) |
Group 4 (n=5) |
Group 5 (n=5) |
All (n=25) |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Participants | Events | Participants | Events | Participants | Events | Participants | Events | Participants | Events | Participants | Events | |
| Pain | ||||||||||||
| Grade 1 | 0 | 0 | 0 | 0 | 1 (20%) | 1 | 0 | 0 | 4 (80%) | 4 | 5 (20%) | 5 |
| Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any | 0 | 0 | 0 | 0 | 1 (20%) | 1 | 0 | 0 | 4 (80%) | 4 | 5 (20%) | 5 |
| Redness | ||||||||||||
| Grade 1 | 0 | 0 | 1 (20%) | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (4%) | 1 |
| Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any | 0 | 0 | 1 (20%) | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (4%) | 1 |
| Fever | ||||||||||||
| Grade 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (20%) | 1 | 0 | 0 | 1 (4%) | 1 |
| Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any | 0 | 0 | 0 | 0 | 0 | 0 | 1 (20%) | 1 | 0 | 0 | 1 (4%) | 1 |
| Headache | ||||||||||||
| Grade 1 | 1 (20%) | 1 | 1 (20%) | 1 | 0 | 0 | 2 (40%) | 6 | 0 | 0 | 4 (16%) | 8 |
| Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (20%) | 1 | 0 | 0 | 1 (4%) | 1 |
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any | 1 (20%) | 1 | 1 (20%) | 1 | 0 | 0 | 3 (60%) | 7 | 0 | 0 | 5 (20%) | 9 |
| Myalgia | ||||||||||||
| Grade 1 | 1 (20%) | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (4%) | 1 |
| Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any | 1 (20%) | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (4%) | 1 |
| Fatigue | ||||||||||||
| Grade 1 | 2 (40%) | 4 | 2 (40%) | 2 | 1 (20%) | 1 | 2 (40%) | 2 | 2 (40%) | 2 | 9 (36%) | 11 |
| Grade 2 | 3 (60%) | 3 | 0 | 0 | 0 | 0 | 1 (20%) | 1 | 0 | 0 | 4 (16%) | 4 |
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any | 5 (100%) | 7 | 2 (40%) | 2 | 1 (20%) | 1 | 3 (60%) | 3 | 2 (40%) | 2 | 13 (52%) | 15 |
Possibly, probably, and definitely related adverse events are reported per group. Local adverse events (pain, redness, and local swelling) are shown from administration to day 7. No local swelling was reported in any of the participants. Solicited systemic adverse events (fever, headache, myalgia, fatigue, chills, or rash) are shown from administration to day 28. No chills or rash were reported in any of the participants.