Table 2 Number of patients with ≥1 pneumonia adverse event in the treatment arms of the 10 included studies, by blood neutrophil count and treatment subgroups
Trials (duration) | Blood neutrophil count: <median, n (%) | Blood neutrophil count: ≥median, n (%) | ||||||
|---|---|---|---|---|---|---|---|---|
n | Pneumonia | Serious pneumonia | Fatal pneumonia | n | Pneumonia | Serious pneumonia | Fatal pneumonia | |
NCT01009463+Exac | ||||||||
(52 weeks) [18] | ||||||||
FF/VI 50/25 | 178 | 12 (6.7) | 6 (3.4) | 0 | 214 | 17 (7.9) | 8 (3.7) | 0 |
FF/VI 100/25 | 210 | 13 (6.2) | 8 (3.8) | 0 | 186 | 12 (6.5) | 3 (1.6) | 0 |
FF/VI 200/25 | 182 | 9 (4.9) | 2 (1.1) | 2 (1.1) | 209 | 21 (10.0) | 11 (5.3) | 4 (1.9) |
VI 25 | 203 | 9 (4.4) | 2 (1.0) | 0 | 196 | 7 (3.6) | 0 | 0 |
NCT01017952+Exac | ||||||||
(52 weeks) [18] | ||||||||
FF/VI 50/25 | 210 | 8 (3.8) | 5 (2.4) | 0 | 190 | 10 (5.3) | 4 (2.1) | 0 |
FF/VI 100/25 | 189 | 11 (5.8) | 5 (2.6) | 0 | 200 | 14 (7.0) | 8 (4.0) | 1 (0.5) |
FF/VI 200/25 | 214 | 13 (6.1) | 5 (2.3) | 0 | 184 | 11 (6.0) | 4 (2.2) | 0 |
VI 25 | 206 | 3 (1.5) | 2 (1.0) | 0 | 193 | 8 (4.1) | 4 (2.1) | 1 (0.5) |
NCT01053988-Exac | ||||||||
(24 weeks) [19] | ||||||||
PBO | 113 | 1 (0.9) | 0 | 0 | 94 | 2 (2.1) | 1 (1.1) | 0 |
FF/VI 50/25 | 108 | 3 (2.8) | 1 (0.9) | 0 | 96 | 0 | 0 | 0 |
FF/VI 100/25 | 109 | 2 (1.8) | 1 (0.9) | 0 | 96 | 4 (4.2) | 0 | 0 |
VI 25 | 107 | 1 (0.9) | 1 (0.9) | 0 | 94 | 4 (4.3) | 2 (2.1) | 0 |
FF 100 | 110 | 2 (1.8) | 2 (1.8) | 0 | 93 | 2 (2.2) | 1 (1.1) | 0 |
NCT01054885-Exac | ||||||||
(24 weeks) [22] | ||||||||
PBO | 96 | 0 | 0 | 0 | 109 | 0 | 0 | 0 |
FF/VI 100/25 | 103 | 0 | 0 | 0 | 100 | 1 (1.0) | 0 | 0 |
FF/VI 200/25 | 82 | 0 | 0 | 0 | 120 | 4 (3.3) | 3 (2.5) | 0 |
VI 25 | 92 | 0 | 0 | 0 | 104 | 2 (1.9) | 2 (1.9) | 0 |
FF 100 | 94 | 1 (1.1) | 0 | 0 | 108 | 2 (1.9) | 0 | 0 |
FF 200 | 106 | 2 (1.9) | 1 (0.9) | 0 | 95 | 1 (1.1) | 1 (1.1) | 0 |
NCT00361959-Exac/+Exac | ||||||||
(104 weeks) [9] | ||||||||
FP/SAL 500/50 | 246 | 15 (6.1) | 11 (4.5) | 1 (0.4) | 388 | 34 (8.8) | 30 (7.7) | 2 (0.5) |
TIO | 236 | 10 (4.2) | 8 (3.4) | 0 | 399 | 13 (3.3) | 11 (2.8) | 0 |
SFCB3024+Exac | ||||||||
PBO | 181 | 3 (1.7) | 1 (0.6) | 0 | 166 | 5 (3.0) | 2 (1.2) | 0 |
FP/SAL 500/50 | 187 | 9 (4.8) | 4 (2.1) | 0 | 154 | 7 (4.5) | 3 (1.9) | 0 |
SAL 50 | 197 | 10 (5.1) | 6 (3.0) | 0 | 158 | 8 (5.1) | 4 (2.5) | 0 |
FP 500 | 176 | 8 (4.5) | 4 (2.3) | 0 | 184 | 10 (5.4) | 5 (2.7) | 0 |
SCO100470-Exac | ||||||||
(24 weeks) [23] | ||||||||
FP/SAL 250/50 | 241 | 1 (0.4) | 0 | 0 | 266 | 2 (0.8) | 2 (0.8) | 0 |
SAL 50 | 256 | 1 (0.4) | 1 (0.4) | 0 | 255 | 3 (1.2) | 3 (1.2) | 0 |
SCO30002-Exac/+Exac | ||||||||
(52 weeks) [24] | ||||||||
PBO | 78 | 1 (1.3) | 1 (1.3) | 0 | 42 | 0 | 0 | 0 |
FP/SAL 500/50 | 78 | 2 (2.6) | 0 | 0 | 51 | 1 (2.0) | 0 | 0 |
FP 500 | 67 | 0 | 0 | 0 | 57 | 0 | 0 | 0 |
SFCA3006-Exac | ||||||||
(24 weeks) [25] | ||||||||
PBO | 104 | 0 | 0 | 1 (1.0) | 76 | 1 (1.3) | 0 | 0 |
FP/SAL 500/50 | 84 | 1 (1.2) | 1 (1.2) | 0 | 79 | 1 (1.3) | 1 (1.3) | 0 |
SAL 50 | 91 | 0 | 0 | 0 | 69 | 0 | 0 | 0 |
FP 500 | 104 | 1 (1.0) | 1 (1.0) | 0 | 63 | 2 (3.2) | 1 (1.6) | 0 |
SFCA3007-Exac | ||||||||
PBO | 89 | 0 | 0 | 0 | 92 | 0 | 0 | 0 |
FP/SAL 250/50 | 102 | 0 | 0 | 0 | 74 | 0 | 0 | 0 |
SAL 50 | 86 | 1 (1.2) | 1 (1.2) | 0 | 91 | 0 | 0 | 0 |
FP 250 | 90 | 1 (1.1) | 0 | 0 | 92 | 1 (1.1) | 1 (1.1) | 0 |