Table 2.
Severe bacterial infection events
| Immediate-initiation group (n=34) | Deferred-initiation group (n=86) | |
|---|---|---|
| Arthritis bacterial | 0 | 2 |
| Bacterial pneumonia (reviewed by ERC) | 14 | 34* |
| Bacterial pyelonephritis | 1 | 0 |
| Campylobacter gastroenteritis | 1 | 2 |
| Cellulitis | 1 | 4 |
| Cellulitis staphylococcal | 0 | 1 |
| Endocarditis bacterial | 0 | 1 |
| Erysipelas | 2 | 3 |
| Escherichia urinary tract infection | 1 | 1 |
| Furuncle | 0 | 1 |
| Gastroenteritis bacterial | 0 | 1 |
| Gastroenteritis salmonella | 1 | 0 |
| Gastroenteritis Shigella | 1 | 2 |
| Meningitis streptococcal | 0 | 1 |
| Pneumococcal bacteraemia | 0 | 1 |
| Shigella infection | 1 | 1 |
| Staphylococcal abscess | 0 | 2 |
| Streptococcal bacteraemia | 1 | 0 |
| Streptococcal sepsis | 0 | 1 |
| Syphilis outside CNS | 1 | 7 |
| Syphilis in CNS | 1 | 4 |
| Tonsillitis streptococcal | 1 | 0 |
| Tuberculosis (pulmonary) | 6 | 17 |
| Tuberculosis (extra-pulmonary) | 0 | 3 |
| Typhoid fever | 1 | 1 |
| Total | 34 | 90* |
Infections are listed as MedDRA preferred terms. ERC=INSIGHT endpoint review committee.
*
Four people had both an ERC review bacterial pneumonia and a bacterial infectious disorder that satisfied one of the following three criteria: grade 4, hospital admission, or death.