Table 6

Mortality among subjects with confirmed clinically serious pulmonary adverse events

MortalityTreatment Group
Total, N (%)P*
Test, N (%)Reference, N (%)
Subjects with CSPAE 14/55 (25.4) 17/45 (37.8) 31/100 (31) .20 
Among subjects with ALI† 9/19 (47.4) 11/16 (68.8) 20/35 (57.1) .31 
Among subjects with ALI only‡ 0/7 (0) 6/11 (54.5) 6/18 (33.3) .04 
Among subjects with ARDS§ 9/12 (75.0) 5/5 (100.0) 14/17 (82.4) .52 
MortalityTreatment Group
Total, N (%)P*
Test, N (%)Reference, N (%)
Subjects with CSPAE 14/55 (25.4) 17/45 (37.8) 31/100 (31) .20 
Among subjects with ALI† 9/19 (47.4) 11/16 (68.8) 20/35 (57.1) .31 
Among subjects with ALI only‡ 0/7 (0) 6/11 (54.5) 6/18 (33.3) .04 
Among subjects with ARDS§ 9/12 (75.0) 5/5 (100.0) 14/17 (82.4) .52 
*

Based upon Fisher exact test.

†

Patients with AECC criteria and a PaO2/FiO2 ratio < 300.

‡

Patients with AECC criteria and a PaO2/FiO2 ratio < 300 but > 200.

§

Patients with AECC criteria and a PaO2/FiO2 ratio < 200.

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