Adjudication Committee Analyses of Causes of Death Through Day 49 Visit in the CREDIBLE-CR Trial
| . | Cefiderocol (N = 101) . | BAT (N = 49) . | . |
|---|---|---|---|
| Cause of Death . | n (%) . | n (%) . | Difference (%) . |
| Overall mortality | 34 (33.7) | 10 (20.4) | 13.3 |
| Directly related to original gram-negative infection | |||
| Failure of study drug treatment | 16 (15.8) | 4 (8.2) | 7.7 |
| No failure of study drug treatment | 1 (1.0) | 1 (2.0) | −1.0 |
| No unanimous vote | 1 (1.0) | 0 | 1.0 |
| Unrelated to original gram-negative infection | |||
| Underlying comorbidity | 10 (9.9) | 2 (4.1) | 5.8 |
| Other infection | 4 (4.0) | 2 (4.1) | −0.1 |
| No unanimous vote | 2 (2.0) | 0 | 2.0 |
| Not assessed by committeea | 0 (0) | 1 (2.0) | −2.0 |
| . | Cefiderocol (N = 101) . | BAT (N = 49) . | . |
|---|---|---|---|
| Cause of Death . | n (%) . | n (%) . | Difference (%) . |
| Overall mortality | 34 (33.7) | 10 (20.4) | 13.3 |
| Directly related to original gram-negative infection | |||
| Failure of study drug treatment | 16 (15.8) | 4 (8.2) | 7.7 |
| No failure of study drug treatment | 1 (1.0) | 1 (2.0) | −1.0 |
| No unanimous vote | 1 (1.0) | 0 | 1.0 |
| Unrelated to original gram-negative infection | |||
| Underlying comorbidity | 10 (9.9) | 2 (4.1) | 5.8 |
| Other infection | 4 (4.0) | 2 (4.1) | −0.1 |
| No unanimous vote | 2 (2.0) | 0 | 2.0 |
| Not assessed by committeea | 0 (0) | 1 (2.0) | −2.0 |
Abbreviation: BAT, best available therapy.
Source: Adapted from Table 1 of “Cefiderocol Adjudication Committee Review and Shionogi’s Assessment – Final.”
aCommittee assessed all deaths until end of study (EOS); 1 additional death occurred after EOS, but prior to day 49 in the BAT group which was not assessed.
Adjudication Committee Analyses of Causes of Death Through Day 49 Visit in the CREDIBLE-CR Trial
| . | Cefiderocol (N = 101) . | BAT (N = 49) . | . |
|---|---|---|---|
| Cause of Death . | n (%) . | n (%) . | Difference (%) . |
| Overall mortality | 34 (33.7) | 10 (20.4) | 13.3 |
| Directly related to original gram-negative infection | |||
| Failure of study drug treatment | 16 (15.8) | 4 (8.2) | 7.7 |
| No failure of study drug treatment | 1 (1.0) | 1 (2.0) | −1.0 |
| No unanimous vote | 1 (1.0) | 0 | 1.0 |
| Unrelated to original gram-negative infection | |||
| Underlying comorbidity | 10 (9.9) | 2 (4.1) | 5.8 |
| Other infection | 4 (4.0) | 2 (4.1) | −0.1 |
| No unanimous vote | 2 (2.0) | 0 | 2.0 |
| Not assessed by committeea | 0 (0) | 1 (2.0) | −2.0 |
| . | Cefiderocol (N = 101) . | BAT (N = 49) . | . |
|---|---|---|---|
| Cause of Death . | n (%) . | n (%) . | Difference (%) . |
| Overall mortality | 34 (33.7) | 10 (20.4) | 13.3 |
| Directly related to original gram-negative infection | |||
| Failure of study drug treatment | 16 (15.8) | 4 (8.2) | 7.7 |
| No failure of study drug treatment | 1 (1.0) | 1 (2.0) | −1.0 |
| No unanimous vote | 1 (1.0) | 0 | 1.0 |
| Unrelated to original gram-negative infection | |||
| Underlying comorbidity | 10 (9.9) | 2 (4.1) | 5.8 |
| Other infection | 4 (4.0) | 2 (4.1) | −0.1 |
| No unanimous vote | 2 (2.0) | 0 | 2.0 |
| Not assessed by committeea | 0 (0) | 1 (2.0) | −2.0 |
Abbreviation: BAT, best available therapy.
Source: Adapted from Table 1 of “Cefiderocol Adjudication Committee Review and Shionogi’s Assessment – Final.”
aCommittee assessed all deaths until end of study (EOS); 1 additional death occurred after EOS, but prior to day 49 in the BAT group which was not assessed.
This PDF is available to Subscribers Only
View Article Abstract & Purchase OptionsFor full access to this pdf, sign in to an existing account, or purchase an annual subscription.
