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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

From: Circulating neutrophils levels are a predictor of pneumonia risk in chronic obstructive pulmonary disease

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
(52 weeks) [20, 21]
 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
(24 weeks) [26, 27]
 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
  1. Definition of abbreviations: FF fluticasone furoate; VI vilanterol; PBO placebo; SAL salmeterol; TIO tiotropium.-Exacstudy conducted in patients without a history of COPD exacerbations; +Exacstudy conducted in patients with a history of exacerbations. Pneumonia/serious pneumonia includes on-treatment events as defined in each individual study. Fatal pneumonia includes on- and post-treatment events