Table 2.
Variable | DOSE 1 |
DOSE 2 |
DOSE 3 |
||||||
---|---|---|---|---|---|---|---|---|---|
Placebo | Abdala | Total | Placebo | Abdala | Total | Placebo | Abdala | Total | |
N | 24,144 | 24,146 | 48,290 | 23,826 | 23,794 | 47,620 | 23,602 | 23,557 | 47,159 |
Subjects with adverse events | 3000 (12.4%) | 3177 (13.2%) | 6177 (12.8%) | 1749 (7.3%) | 1983 (8.3%) | 3732 (7.8%) | 579 (2.5%) | 639 (2.7%) | 1218 (2.6%) |
Total of adverse events (15,937) | 4318 (48.7%) | 4545 (51.3%) | 8863 (55.6%) | 2442 (46.0%) | 2861 (54.0%) | 5303 (33.3%) | 838 (47.3%) | 933 (52.7%) | 1771 (11.1%) |
Intensity | |||||||||
Mild | 3942 (91.3%) | 4166 (91.7%) | 8108 (91.5%) | 2208 (90.4%) | 2598 (90.8%) | 4806 (90.6%) | 719 (85.8%) | 781 (83.7%) | 1500 (84.7%) |
Moderate | 371 (8.6%) | 366 (8.1%) | 737 (8.3%) | 230 (9.4%) | 260 (9.1%) | 490 (9.2%) | 114 (13.6%) | 150 (16.1%) | 264 (14.9%) |
Severe (Grade 3) | 2 (0.04%) | 1 (0.02%) | 3 (0.03%) | 0 | 0 | 0 | 5 (0.6%) | 2 (0.2%) | 7 (0.4%) |
Serious (Grade 4) | 2 (0.04%) | 1 (0.02%) | 3 (0.03%) | 0 | 1 (0.03%) | 1 (0.01%) | 0 | 0 | 0 |
Serious (Grade 5) | 1 (0.02%) | 3 (0.07%) | 4 (0.05%) | 4 (0.2%) | 2 (0.07%) | 6 (0.1%) | 0 | 0 | 0 |
Causality (WHO) | |||||||||
Inconsistent with vaccination | 2871 (66.5%) | 2849 (62.7%) | 5720 (64.5%) | 1632 (66.8%) | 1746 (61.0%) | 3378 (63.7%) | 588 (70.2%) | 561 (60.1%) | 1149 (64.9%) |
Indeterminate | 596 (13.8%) | 614 (13.5%) | 1210 (13.7%) | 334 (13.7%) | 377 (13.2%) | 711 (13.4%) | 97 (11.6%) | 108 (11.6%) | 205 (11.6%) |
Consistent with vaccination | 851 (19.7%) | 1082 (23.8%) | 1933 (21.8%) | 476 (19.5%) | 738 (25.8%) | 1214 (22.9%) | 153 (18.3%) | 264 (28.3%) | 417 (23.5%) |
Action taken | |||||||||
None | 2817 (65.2%) | 3025 (66.6%) | 5842 (65.9%) | 1629 (66.7%) | 1962 (68.6%) | 3591 (67.7%) | 584 (69.7%) | 628 (67.3%) | 1212 (68.4%) |
Non-drug therapy | 132 (3.1%) | 133 (2.9%) | 265 (3.0%) | 44 (1.8%) | 52 (1.8%) | 96 (1.8%) | 9 (1.1%) | 16 (1.7%) | 25 (1.4%) |
Drug therapy | 1372 (31.8%) | 1385 (30.5%) | 2757 (31.1%) | 762 (31.2%) | 842 (29.4%) | 1604 (30.2%) | 241 (28.8%) | 289 (31.0%) | 530 (29.9%) |
Hospitalization | 1 (0.02%) | 0 | 1 (0.01%) | 3 (0.1%) | 0 | 3 (0.05%) | 4 (0.5%) | 0 | 4 (0.2%) |
Withdrawal from study | 6 (0.1%) | 11 (0.2%) | 17 (0.2%) | 4 (0.2%) | 5 (0.2%) | 9 (0.2%) | 0 | 0 | 0 |
Outcome | |||||||||
Completely resolved | 4277 (99.1%) | 4499 (99.0%) | 8776 (99.0%) | 2421 (99.1%) | 2845 (99.4%) | 5266 (99.3%) | 822 (98.1%) | 919 (98.5%) | 1741 (98.3%) |
Resolved with sequelae | 4 (0.09%) | 4 (0.09%) | 8 (0.09%) | 2 (0.08%) | 2 (0.07%) | 4 (0.07%) | 0 | 0 | 0 |
Getting better | 28 (0.6%) | 27 (0.6%) | 55 (0.6%) | 11 (0.5%) | 9 (0.3%) | 20 (0.4%) | 12 (1.4%) | 10 (1.1%) | 22 (1.2%) |
Present and unchanged | 8 (0.2%) | 11 (0.2%) | 19 (0.3%) | 4 (0.2%) | 3 (0.1%) | 7 (0.1%) | 4 (0.5%) | 4 (0.4%) | 8 (0.5%) |
Worsening | 0 | 1 (0.02%) | 1 (0.01%) | 0 | 0 | 0 | 0 | 0 | 0 |
Death from adverse event | 1 (0.02%) | 3 (0.07%) | 4 (0.05%) | 4 (0.2%) | 2 (0.07%) | 6 (0.1%) | 0 | 0 | 0 |
The variable Action taken was tabulated following a hierarchical structure, to ensure that its categories are exclusive. Levels of this variable are ordered from least to most “drastic” measures: None, Non-pharmacological therapy, Pharmacological therapy, Hospitalization and Withdrawal from the study.