Table 3.
Incidence of related adverse events by system organ class and relationship to study treatment
| MedDRA system organ class | Treatment group | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Tat vaccine | Placebo | Total | |||||||||||||
| Relateda | Not relatedb | Relateda | Not relatedb | ||||||||||||
| n | (m) | % | n | (m) | % | n | (m) | % | n | (m) | % | n | (m) | % | |
| Number of subjects | 100 | 100 | 100 | 100 | 200 | ||||||||||
| Number of subjects with at least one adverse event | 77 | (621) | 77.0 | 85 | (262) | 85.0 | 72 | (344) | 72.0 | 81 | (237) | 81.0 | 190 | (1464) | 95.0 |
| General disorders and administration site conditions | 73 | (520) | 73.0 | 8 | (10) | 8.0 | 58 | (199) | 58.0 | 11 | (12) | 11.0 | 133 | (741) | 66.5 |
| Infections and infestations | 1 | (1) | 1.0 | 50 | (77) | 50.0 | 2 | (2) | 2.0 | 56 | (88) | 56.0 | 107 | (168) | 53.5 |
| Nervous system disorders | 27 | (40) | 27.0 | 19 | (24) | 19.0 | 38 | (67) | 38.0 | 10 | (13) | 10.0 | 81 | (144) | 40.5 |
| Musculoskeletal and connective tissue disorders | 16 | (25) | 16.0 | 14 | (16) | 14.0 | 17 | (31) | 17.0 | 15 | (28) | 15.0 | 54 | (100) | 27.0 |
| Gastrointestinal disorders | 9 | (12) | 9.0 | 20 | (25) | 20.0 | 14 | (18) | 14.0 | 13 | (19) | 13.0 | 49 | (74) | 24.5 |
| Skin and subcutaneous tissue disorders | 10 | (12) | 10.0 | 15 | (15) | 15.0 | 10 | (18) | 10.0 | 13 | (16) | 13.0 | 47 | (61) | 23.5 |
| Reproductive system and breast disorders | 0 | (0) | 22 | (24) | 22.0 | 0 | (0) | 22 | (27) | 22.0 | 44 | (51) | 22.0 | ||
| Investigations | 2 | (3) | 2.0 | 19 | (28) | 19.0 | 2 | (2) | 2.0 | 8 | (10) | 8.0 | 30 | (43) | 15.0 |
| Blood and lymphatic system disorders | 7 | (7) | 7.0 | 7 | (9) | 7.0 | 5 | (6) | 5.0 | 3 | (3) | 3.0 | 21 | (25) | 10.5 |
| Injury, poisoning and procedural complications | 0 | (0) | 10 | (12) | 10.0 | 0 | (0) | 5 | (7) | 5.0 | 15 | (19) | 7.5 | ||
| Vascular disorders | 1 | (1) | 1.0 | 6 | (6) | 6.0 | 0 | (0) | 3 | (3) | 3.0 | 10 | (10) | 5.0 | |
| Respiratory, thoracic and mediastinal disorders | 0 | (0) | 2 | (2) | 2.0 | 0 | (0) | 4 | (5) | 4.0 | 6 | (7) | 3.0 | ||
| Eye disorders | 0 | (0) | 3 | (3) | 3.0 | 0 | (0) | 2 | (2) | 2.0 | 5 | (5) | 2.5 | ||
| Metabolism and nutrition disorders | 0 | (0) | 3 | (3) | 3.0 | 0 | (0) | 1 | (1) | 1.0 | 4 | (4) | 2.0 | ||
| Renal and urinary disorders | 0 | (0) | 2 | (2) | 2.0 | 0 | (0) | 1 | (1) | 1.0 | 3 | (3) | 1.5 | ||
| Surgical and medical procedures | 0 | (0) | 2 | (2) | 2.0 | 0 | (0) | 1 | (1) | 1.0 | 3 | (3) | 1.5 | ||
| Psychiatric disorders | 0 | (0) | 2 | (4) | 2.0 | 0 | (0) | 0 | (0) | 2 | (4) | 1.0 | |||
| Cardiac disorders | 0 | (0) | 0 | (0) | 1 | (1) | 1.0 | 0 | (0) | 1 | (1) | 0.5 | |||
| Immune system disorders | 0 | (0) | 0 | (0) | 0 | (0) | 1 | (1) | 1.0 | 1 | (1) | 0.5 | |||
n = number of subjects, (m) = number of mentions, % = all percentages are expressed as the percentage of subjects in the safety population in each treatment group. Adverse event data were coded using the MedDRA dictionary version 15.0
aRelated refers to events whose relationship to the study treatment was regarded as certain, probable or possible
bNot related refers to events whose relationship to the study treatment was regarded as unrelated or unlikely related