Comparison of infectious complications between clinical trial patients and historic controls
| . | Toci n = 45 . | No Toci n = 39 . | P value . |
|---|---|---|---|
| Total bacterial infections,∗ n | 65 | 39 | |
| Incidence rate ratio | 1.52 (95% CI, 0.93-2.48) | P = .092 | |
| Bacteremias | |||
| Gram-positive bacteremia, n | 24 | 8 | |
| Incidence rate ratio | 2.74 (95% CI, 1.31-5.73) | P = .007 | |
| Gram-negative bacteremia, n | 13 | 11 | |
| Incidence rate ratio | 1.08 (95% CI, 0.4-2.91) | P = .88 | |
| CMV,† n | 0 | 19 | |
| Cumulative incidence (day 90) | - | 79% (95% CI, 55-91) | |
| HHV-6,‡ n | 43 | 39 | |
| Cumulative incidence (day 90) | 96% (95% CI, 81-99) | 100% (95% CI, 100-100) | |
| Other viral infections,§ n (%) | |||
| Adenovirus | 4 (8.9) | 3 (7.7) | |
| EBV | 2 (4.4) | 0 | |
| Respiratory virus, n (%) | 6 (13) | 5 (13) | |
| Fungal infections,§ n (%) | |||
| Possible | 1 (2) | 1 (3) | |
| Probable | 0 | 0 | |
| Proven | 0 | 1 (3) | |
| . | Toci n = 45 . | No Toci n = 39 . | P value . |
|---|---|---|---|
| Total bacterial infections,∗ n | 65 | 39 | |
| Incidence rate ratio | 1.52 (95% CI, 0.93-2.48) | P = .092 | |
| Bacteremias | |||
| Gram-positive bacteremia, n | 24 | 8 | |
| Incidence rate ratio | 2.74 (95% CI, 1.31-5.73) | P = .007 | |
| Gram-negative bacteremia, n | 13 | 11 | |
| Incidence rate ratio | 1.08 (95% CI, 0.4-2.91) | P = .88 | |
| CMV,† n | 0 | 19 | |
| Cumulative incidence (day 90) | - | 79% (95% CI, 55-91) | |
| HHV-6,‡ n | 43 | 39 | |
| Cumulative incidence (day 90) | 96% (95% CI, 81-99) | 100% (95% CI, 100-100) | |
| Other viral infections,§ n (%) | |||
| Adenovirus | 4 (8.9) | 3 (7.7) | |
| EBV | 2 (4.4) | 0 | |
| Respiratory virus, n (%) | 6 (13) | 5 (13) | |
| Fungal infections,§ n (%) | |||
| Possible | 1 (2) | 1 (3) | |
| Probable | 0 | 0 | |
| Proven | 0 | 1 (3) | |
Bacterial infections (total bacterial infections, gram-positive bacteremias, gram-negative bacteremias) were compared using Poisson regression to account for multiple infections per patient with an offset term to account for days at risk.
CMV infection cumulative incidence was calculated among CMV seropositive patients only with death and second transplant as competing events.
HHV-6 reactivation is presented using cumulative incidence with death and second transplant as competing events. Only 2 patients in each group required HHV-6 directed therapy.
Other viral infections (EBV, adenovirus, respiratory viruses) and fungal infections are presented descriptively because of small numbers. Only 1 adenovirus infection in each group required antiviral therapy. One patient with EBV received pre-emptive rituximab before day 100.