Table 6.
Clinical features of BCG local adverse reactions (abscess and lymphadenopathy).
| Injection site abscess | Total BCG | BCG (Stage 1) | BCG (Stage 2) | Placebo (Stage 2) |
|---|---|---|---|---|
| n = 55 | n = 41 | n = 14 | n = 0 | |
| Clinical features | ||||
| Time to onset, days | 20 (2–45) | 20 (3–45) | 17 (2–38) | – |
| Maximum size, cm | 2.0 (1.5–5.0) | 2.0 (1.5–5.0) | 2.0 (1.5–3.0) | |
| Abscess with discharge, No. (%) | 54 (98%) | 40 (98%) | 14 (100%) | |
| Abscess with persistent discharge (>2w), No. (%) | 32 (58%) | 24 (59%) | 8 (57%) | |
| Abscess with pain/tenderness at site, No. (%) | 54 (98%) | 40 (98%) | 14 (100%) | |
| Management | ||||
| Observation, No. (%) | 44 (80%) | 34 (83%) | 10 (71%) | – |
| Maximum size, cm | 2.0 (1.5–5.0) | 2.0 (1.5–5.0) | 2.0 (1.5–3.0) | |
| Time to resolution, days | 27 (2–243) | 27 (2–243) | 27 (4–102) | |
| Antimicrobial only, No. (%) | 7 (13%) | 5 (12%) | 2 (14%) | |
| Topical antibiotic (mupirocin) | 1 | 1 | 0 | |
| Maximum size, cm | 2.5 | 2.5 | – | |
| Time to resolution, days | 28 | 28 | – | |
| Oral antibiotics (cephalexin/flucloxacillin) | 3 | 2 | 1 | |
| Maximum size, cm | 3.0 (2.0–5.0) | 3.5 (2.0–5.0) | 3.0 | |
| Time to resolution, days | 21 (8–88) | 15 (8–21) | 88 | |
| IV antibiotics (flucloxacillin) | 1 | 0 | 1 | |
| Maximum size, cm | nr | – | nr | |
| Time to resolution, days | 16 | – | 16 | |
| Oral isoniazid | 2 | 2 | 0 | |
| Maximum size, cm | 4.3 (4.0–4.5) | 4.3 (4.0–4.5) | – | |
| Time to resolution, days | 131 (113–149) | 131 (113–149) | – | |
| FNA + cephalexin/flucloxacillin, No. (%) | 3 (5%) | 2 (5%) | 1 (7%) | |
| Maximum size, cm | 2.0 (2.0–2.5) | 2.0 (2.0–2.0) | 2.5 | |
| Time to resolution, days | 30 (20–56) | 43 (30–56) | 20 | |
| Surgical excision + co-amoxiclav, No. (%) | 1 (2%) | 0 | 1 (7%) | |
| Maximum size, cm | 1.5 | – | 1.5 | |
| Time to resolution, days |
62 |
– |
62 |
|
| Lymphadenopathy | Total BCG | BCG (Stage 1) | BCG (Stage 2) | Placebo (Stage 2) |
| |
n = 101 |
n = 48 |
n = 53 |
n = 9 |
| Clinical features | ||||
| Time to onset, days | 5 (1–56) | 6 (1–56) | 4 (1–40) | 4 (2–30) |
| Maximum size, cm | 1.0 (0.5–4.0) | 1.8 (0.5–4.0) | 1.0 (0.5–4.0) | 1.0 (0.5–5.0) |
| No. (%) with pain/tenderness at site | 43 (43%)* | 30 (63%) | 13 (25%) | 3 (33%) |
| Time to resolution, days | 3 (1–30) | 4 (1–30) | 3 (1–14) | 4 (1–22) |
Abbreviations: FNA, fine needle aspiration; nr, not reported.
*Two participants took opioid analgesia for axillary pain associated with lymphadenopathy; one took codeine for two days and the other buprenorphine for four days following an emergency department presentation for the axillary pain.
Categorical variables are reported as number (%), continuous variables are reported as median (range).