Mortality risk between 2 and 12 months by 2-month BCG reaction status and size
| BCG skin reaction | 2–12 month mortality rate per 100 Pyrs (deaths/Pyrs) (N) | Crude* MRR (95% CI) | Adjusted† MRR (95% CI) |
| Mortality risk by BCG reaction status | |||
| No reaction | 6.3 (10/159) (208) | Ref. | Ref. |
| Has reaction | 2.4 (109/4504) (5804) | 0.48 (0.25 to 0.93) | 0.49 (0.26 to 0.95) |
| Mortality risk by BCG reaction size | |||
| Small reaction | 3.8 (64/1704) (2213) | Ref. | Ref. |
| Medium reaction | 2.3 (30/1333) (1710) | 0.68 (0.44 to 1.05) | 0.69 (0.44 to 1.07) |
| Large reaction | 1.0 (15/1466) (1881) | 0.33 (0.19 to 0.58) | 0.35 (0.20 to 0.63) |
| BCG-Denmark (RCTs I–V) | |||
| Mortality risk by BCG reaction size | |||
| Small reaction | 4.3 (53/1229) (1604) | Ref. | Ref. |
| Medium reaction | 3.1 (28/912) (1178) | 0.80 (0.50 to 1.26) | 0.82 (0.51 to 1.31) |
| Large reaction | 1.4 (14/1014) (1295) | 0.39 (0.22 to 0.71) | 0.43 (0.23 to 0.78) |
| BCG-Japan (RCTs IV–V) | |||
| Mortality risk by BCG reaction size | |||
| Small reaction | 3.1 (5/159) (205) | Ref. | Ref. |
| Medium reaction | 0.5 (1/184) (235) | 0.18 (0.02 to 1.55) | 0.17 (0.02 to 1.47) |
| Large reaction | 0.4 (1/283) (369) | 0.12 (0.01 to 1.03) | 0.11 (0.01 to 0.96) |
| BCG-Russia (RCT V) | |||
| Mortality risk by BCG reaction size | |||
| Small reaction | 1.9 (6/316) (404) | Ref. | Ref. |
| Medium reaction | 0.4 (1/238) (297) | 0.22 (0.03 to 1.86) | 0.19 (0.02 to 1.59) |
| Large reaction | 0.0 (0/169) (217) | – | – |
*Cox proportional hazards survival analysis (unadjusted, stratified by RCT), comparing mortality risk by reaction status (yes/no) and by BCG reaction size.
†Cox proportional hazards survival analysis by BCG reaction status (has reaction versus no reaction, small versus medium and small versus large reaction size) adjusted for maternal MUAC, year and 2-month reaction assessor, stratified by study, providing the aMRR estimate.
BCG, Bacille Calmette-Guérin; MRR, mortality rate ratio; Pyrs, person-years.