TABLE 1.
Frequency and severity of headache, malaise, and myalgia after either dose, tabulated by treatment groups
| Size of dose (mg) | Headache results
|
Malaise results
|
Myalgia results
|
|||
|---|---|---|---|---|---|---|
| No. of subjects with any headachea | Median severity gradeb | No. of subjects with any malaisea | Median severity gradeb | No. of subjects with any myalgiaa | Median severity gradeb | |
| 0.1 | 4/5 | 1 | 3/5 | 1 | 2/5 | 1 |
| 0.4c | 3/10 | 1 | 4/10 | 1.5 | 4/10 | 2.5 |
| 1.0 | 2/10 | 2 | 4/10 | 1 | 1/10 | 2 |
| 1.5 | 4/10 | 1.5 | 5/10 | 1 | 2/10 | 1 |
a
Subjects reporting the complaint at any nonzero grade after either immunization. Total number of subjects is also given.
b
Results are based on highest severity grade reported by all subjects with nonzero reports after either immunization. Grades: 0, none; 1, barely noticeable; 2, noticeable but not interfering with any daily activity; 3, interfering with daily activities to any extent.
c
Includes subject with documented streptococcal pharyngitis.