Table 7.
Sub-cohort 1 |
Sub-cohort 2 |
Sub-cohort 3 |
||||
---|---|---|---|---|---|---|
n (%) | MMR-RIT (N = 802) |
MMR II (N = 298) |
MMR-RIT (N = 796) |
MMR II (N = 303) |
MMR-RIT (N = 1319) |
MMR II (N = 489) |
Unsolicited AEs (≥1 symptom) | 276 (34.4) | 90 (30.2) | 314 (39.4) | 112 (37.0) | 508 (38.5) | 186 (38.0) |
Grade 3a | 24 (3.0) | 11 (3.7) | 19 (2.4) | 10 (3.3) | 29 (2.2) | 11 (2.2) |
SAEs (any, ≥1 SAE) | 4 (0.5) | 0 (0.0) | 14 (1.8) | 1 (0.3) | 25 (1.9) | 9 (1.8) |
NOCDs (any, ≥1 NOCD) | 8 (1.0) | 4 (1.3) | 6 (0.8) | 0 (0.0) | 11(0.8) | 3 (0.6) |
AE, adverse event; SAE, serious adverse event; N, number of participants with the administered dose; n (%), number (percentage) of participants reporting an AE at least once; NOCDs, new onset chronic diseases.
aUnsolicited AEs of grade 3 intensity were those preventing normal, everyday activities.