Table 2.
Local injection site reactions for stage 2 participants.
| Total Stage 2 | BCG | Placebo | p-value | |
|---|---|---|---|---|
| n = 3964 | n = 1992 | n = 1972 | ||
| Pain | 1121 (28.3%) | 982 (49.3%) | 139 (7.0%) | <0.001 |
| None | 2843 (71.7%) | 1010 (50.7%) | 1833 (93.0%) | |
| Grade 1 | 991 (25.0%) | 863 (43.3%) | 128 (6.5%) | 0.1a |
| Grade 2 | 122 (3.1%) | 113 (5.7%) | 9 (0.5%) | |
| Grade 3 | 7 (0.2%) | 5 (0.3%) | 2 (0.1%) | |
| Grade 4 | 1 (<0.1%) | 1 (<0.1%) | 0 (0.0%) | |
| Onset, days | 2 (1–3) | 2 (1–3) | 1 (1–2) | <0.001 |
| Duration, days | 5 (2–9) | 5 (3–9) | 2 (1–4) | <0.001 |
| Tenderness | 1384 (34.9%) | 1241 (62.3%) | 143 (7.2%) | <0.001 |
| None | 2580 (65.1%) | 751 (37.7%) | 1829 (92.8%) | |
| Grade 1 | 1059 (26.7%) | 947 (47.5%) | 112 (5.7%) | 0.04a |
| Grade 2 | 241 (6.1%) | 212 (10.6%) | 29 (1.5%) | |
| Grade 3 | 83 (2.1%) | 81 (4.1%) | 2 (0.1%) | |
| Grade 4 | 1 (<0.1%) | 1 (0.1%) | 0 (0.0%) | |
| Onset, days | 2 (1–2) | 2 (1–3) | 1 (1–2) | <0.001 |
| Duration, days | 6 (4–12) | 7 (4–13) | 1 (1–3) | <0.001 |
| Erythema | 1944 (49.0%) | 1878 (94.3%) | 66 (3.3%) | <0.001 |
| None | 2020 (51.0%) | 114 (5.7%) | 1906 (96.7%) | |
| Grade 1 | 1891 (47.7%) | 1826 (91.7%) | 65 (3.3%) | 1.0a |
| Grade 2 | 52 (1.3%) | 51 (2.6%) | 1 (0.1%) | |
| Grade 3 | 1 (<0.1%) | 1 (0.1%) | 0 (0.0%) | |
| Grade 4 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Onset, days | 1 (1–2) | 1 (1–2) | 1 (1–2) | 0.03 |
| Duration, days | 13 (9–14) | 13 (9–14) | 2 (1–5) | <0.001 |
| Maximal diameter, cm | 1.5 (1.0, 2.0) | 1.5 (1.0, 2.0) | 0.5 (0.3, 1.0) | <0.001 |
| Swelling | 1653 (41.7%) | 1589 (79.8%) | 64 (3.3%) | <0.001 |
| None | 2311 (58.3%) | 403 (20.2%) | 1908 (96.7%) | |
| Grade 1 | 1522 (38.4%) | 1460 (73.3%) | 62 (3.1%) | 0.04a |
| Grade 2 | 126 (3.2%) | 125 (6.3%) | 1 (0.1%) | |
| Grade 3 | 5 (0.1%) | 4 (0.2%) | 1 (0.1%) | |
| Grade 4 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Onset, days | 2 (1–3) | 2 (1–3) | 1 (1–2) | <0.001 |
| Duration, days | 9 (5–13) | 9 (5–14) | 1 (1–4) | <0.001 |
| Maximal diameter, cm |
1.0 (0.5, 1.5) |
1.0 (0.5, 1.5) |
0.5 (0.2, 1.0) |
<0.001 |
| |
Total Stage 2 n = 3772 |
BCG n = 1900 |
Placebo n = 1872 |
|
| Itch* | 926 (24.5%) | 862 (45.4%) | 64 (3.4%) | <0.001 |
| None | 2846 (75.5%) | 1038 (54.6%) | 1808 (96.6%) | |
| Grade 1 | 897 (23.8%) | 839 (44.2%) | 58 (3.1%) | 0.01a |
| Grade 2 | 29 (0.8%) | 23 (1.2%) | 6 (0.3%) | |
| Grade 3 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Grade 4 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Onset, days | 3 (2–7) | 3 (2–7) | 2 (1–6) | 0.09 |
| Duration, days | 7 (4–20) | 10 (5–20) | 3 (2–7) | <0.001 |
Data are presented as n (%) or median (interquartile range), unless otherwise specified.
*Itch evaluated in 6-month follow-up questionnaire.
In the BCG group, antihistamines were taken by 13 participants, 1 participant applied a topical steroid cream and 1 took paracetamol to relieve the itch. In the placebo group, 2 participants took antihistamines and 1 participant took acyclovir for the itch.
ap-value comparing reaction severity Grades 1 to 4, between BCG and placebo groups.