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. 2019 May 1;10:387. doi: 10.3389/fphar.2019.00387

Table 2.

The incidence of adverse events in all grade or grade ≥3.

Any grade Grade ≥3
AEs Treatment Included study Event Total patients Pooled rate (95%Cl) Model P-value Included study Event Total patients Pooled rate (95%Cl) Model P-value
GENERAL
Fatigue Nivolumab 4 40 202 0.2018 [0.1514; 0.2636] Fixed 0.007 4 0 202 0.0121 [0.0030; 0.0471] Fixed 0.2200
Pembrolizumab 4 28 284 0.1024 [0.0715; 0.1445] Fixed 3 3 253 0.0280 [0.0044; 0.1595] Random
Overall 8 68 486 0.1491 [0.1027; 0.2113] Random 7 3 455 0.0245 [0.0113; 0.0524] Fixed
Pyrexia Nivolumab 3 16 122 0.1675 [0.0486; 0.4422] Random 0.442 3 1 122 0.0367 [0.0105; 0.1199] Fixed 0.49
Pembrolizumab 3 26 253 0.1030 [0.0711; 0.1471] Fixed 3 2 253 0.0208 [0.0073; 0.0579] Fixed
Overall 6 42 375 0.1300 [0.0728; 0.2213] Random 6 3 375 0.0263 [0.0118; 0.0575] Fixed
Chills Pembrolizumab 3 9 266 0.0386 [0.0202; 0.0727] Fixed 2 0 235 0.0067 [0.0009; 0.0463] Fixed
Asthenia Pembrolizumab 2 5 241 0.0288 [0.0064; 0.1199] Random 1 1 33 0.0303
RESPIRATORY
Pneumonitis Nivolumab 2 12 162 0.0629 [0.0129; 0.2571] Random 0.859 2 5 162 0.0370 [0.0155; 0.0860] Fixed 0.853
Pembrolizumab 2 4 49 0.0840 [0.0319; 0.2037] Fixed 1 1 33 0.0303
Overall 4 15 211 0.0942 [0.0574; 0.1508] Fixed 3 6 195 0.0358 [0.0161; 0.0775] Fixed
Embolism Nivolumab 2 1 162 0.0138 [0.0035; 0.0535] Fixed 2 1 162 0.0138 [0.0035; 0.0535] Fixed
Cough Nivolumab 1 2 23 0.0879 1 0 23 0
Pembrolizumab 2 19 235 0.1297 [0.0236; 0.4793] Random 2 1 235 0.0091 [0.0023; 0.0357] Fixed
Overall 3 21 258 0.1156 [0.0346; 0.3226] Random 3 1 258 0.0107 [0.0031; 0.0364] Fixed
Upper respiratory tract infection Nivolumab 2 5 97 0.0603 [0.0010; 0.8038] Random 2 0 97 0.0130 [0.0018; 0.0871] Fixed
Pembrolizumab 1 13 210 0.0619 1 0 210 0
Overall 3 18 307 0.0780 [0.0147; 0.3243] Random 3 0 307 0.0074 [0.0015; 0.0358] Fixed
Dyspnea Nivolumab 1 3 80 0.0375 1 1 80 0.0125
Pembrolizumab 3 17 266 0.0951 [0.0172; 0.3873] Random 2 6 235 0.0424 [0.0024; 0.4524] Random
Overall 4 20 346 0.0764 [0.0202; 0.2489] Random 3 7 315 0.0298 [0.0036; 0.2068] Random
SKIN
Rash Nivolumab 4 35 202 0.1927 [0.1146; 0.3057] Random 0.008 4 5 202 0.0366 [0.0175; 0.0749] Fixed 0.651
Pembrolizumab 2 18 235 0.0766 [0.0488; 0.1183] Fixed 2 1 235 0.0145 [0.0006; 0.2577] Random
Overall 6 53 437 0.1480 [0.0869; 0.2408] Random 6 6 437 0.0338 [0.0176; 0.0639] Fixed
Pruritus Nivolumab 4 24 202 0.1403 [0.0707; 0.2593] Random 4 0 202 0.0121 [0.0030; 0.0471] Fixed
Pembrolizumab 1 8 210 0.0381 1 0 210 0
Overall 5 32 412 0.1081 [0.0509; 0.2152] Random 5 0 412 0.0087 [0.0025; 0.0296] Fixed
GASTROINTESTINAL
Decreased appetite Nivolumab 2 9 162 0.0532 [0.0160; 0.1621] Random 0.645 2 0 162 0.0061 [0.0009; 0.0420] Fixed
Pembrolizumab 2 4 49 0.0844 [0.0320; 0.2045] Fixed 1 0 18 0
Overall 4 13 211 0.0701 [0.0410; 0.1172] Fixed 3 0 180 0.0099 [0.0020; 0.0476] Fixed
Diarrhea Nivolumab 4 19 202 0.0959 [0.0620; 0.1455] Fixed 0.9710 4 0 202 0.0121 [0.0030; 0.0471] Fixed 0.853
Pembrolizumab 4 26 284 0.0969 [0.0667; 0.1387] Fixed 3 2 253 0.0142 [0.0050; 0.0398] Fixed
Overall 8 45 486 0.0965 [0.0727; 0.1269] Fixed 7 2 455 0.0134 [0.0058; 0.0306] Fixed
Nausea Nivolumab 2 13 103 0.1262 [0.0747; 0.2054] Fixed 0.305 2 0 103 0.0113 [0.0016; 0.0761] Fixed 0.958
Pembrolizumab 4 23 284 0.1069 [0.0547; 0.1983] Random 3 0 253 0.0106 [0.0021; 0.0509] Fixed
Overall 6 36 387 0.1016 [0.0741; 0.1380] Fixed 5 0 356 0.0109 [0.0031; 0.0369] Fixed
Vomiting Nivolumab 1 6 80 0.0750 1 0 80 0
Pembrolizumab 3 13 266 0.0533 [0.0311; 0.0899] Fixed 2 0 235 0.0067 [0.0009; 0.0463] Fixed
Overall 4 19 346 0.0594 [0.0381; 0.0913] Fixed 3 0 315 0.0065 [0.0013; 0.0318] Fixed
Constipation Nivolumab 2 7 97 0.0746 [0.0359; 0.1484] Fixed 0.134 2 0 97 0.0130 [0.0018; 0.0871] Fixed
Pembrolizumab 2 8 241 0.0349 [0.0175; 0.0683] Fixed 1 0 210 0
Overall 4 15 338 0.0495 [0.0300; 0.0807] Fixed 3 0 307 0.0074 [0.0015; 0.0358] Fixed
Stomatitis Nivolumab 2 4 105 0.0456 [0.0171; 0.1157] Fixed 2 2 105 0.0229 [0.0057; 0.0873] Fixed
HEPATIC
Lipase increased Nivolumab 2 5 105 0.0514 [0.0215; 0.1179] Fixed 4 18 428 0.0454 [0.0288; 0.0710] Fixed
AST increased Nivolumab 1 4 80 0.0500 1 2 80 0.0250
Pembrolizumab 1 2 31 0.0645 1 1 31 0.0323
Overall 2 6 111 0.0544 [0.0246; 0.1159] Fixed 2 3 111 0.0272 [0.0088; 0.0810] Fixed
ALT increased Nivolumab 1 3 80 0.0375 2 9 323 0.0279 [0.0146; 0.0528] Fixed
Pembrolizumab 1 2 31 0.0645 1 1 31 0.0323
Overall 2 5 111 0.0465 [0.0195; 0.1070] Fixed 3 10 354 0.0283 [0.0153; 0.0518] Fixed
ENDOCRINE
Hypothyroidism Nivolumab 2 7 40 0.1789 [0.0493; 0.4780] Random 0.251 2 0 40 0.0241 [0.0034; 0.1520] Fixed 0.463
Pembrolizumab 3 33 259 0.1279 [0.0924; 0.1745] Fixed 2 1 228 0.0098 [0.0025; 0.0385] Fixed
Overall 5 40 299 0.1377 [0.1025; 0.1826] Fixed 4 1 268 0.0132 [0.0043; 0.0403] Fixed
NEURAL
Headache Nivolumab 2 6 97 0.0844 [0.0080; 0.5126] Random 2 0 97 0.0130 [0.0018; 0.0871] Fixed
Pembrolizumab 1 13 210 0.0619 1 0 210 0
Overall 3 19 307 0.0768 [0.0246; 0.2155] Random 3 0 307 0.0074 [0.0015; 0.0358] Fixed
Back pain Nivolumab 2 4 97 0.0544 [0.0113; 0.2244] Random 2 0 97 0.0130 [0.0018; 0.0871] Fixed 0.669
Pembrolizumab 1 4 210 0.0190 2 1 241 0.0132 [0.0007; 0.2022] Random
Overall 3 8 307 0.0358 [0.0119; 0.1026] Random 4 1 338 0.0184 [0.0059; 0.0559] Fixed
Myalgia Nivolumab 2 8 97 0.0838 [0.0424; 0.1587] Fixed 2 0 97 0.0130 [0.0018; 0.0871] Fixed
Pembrolizumab 1 5 210 0.0238 1 0 210 0
Overall 3 13 307 0.0552 [0.0216; 0.1343] Random 3 0 307 0.0074 [0.0015; 0.0358] Fixed
Arthralgia Nivolumab 1 11 80 0.1375 1 0 80 0.0062
Pembrolizumab 1 8 210 0.0381 1 1 210 0.0048
Overall 2 19 290 0.0742 [0.0201; 0.2388] Random 2 1 290 0.0069 [0.0017; 0.0270] Fixed
HEMATOLOGIC
Anemia Nivolumab 2 8 162 0.0507 [0.0256; 0.0982] Fixed 0.955 2 3 162 0.0331 [0.0124; 0.0850] Fixed 0.945
Pembrolizumab 2 11 235 0.0579 [0.0005; 0.8856] Random 2 5 235 0.0296 [0.0003; 0.7551] Random
Overall 3 16 317 0.0576 [0.0098; 0.2741] Random 3 8 317 0.0292 [0.0046; 0.1631] Random
Neutropenia Nivolumab 2 10 162 0.0670 [0.0364; 0.1203] Fixed 0.649 3 12 405 0.0322 [0.0183; 0.0558] Fixed 0.243
Pembrolizumab 3 14 253 0.0558 [0.0333; 0.0921] Fixed 4 14 286 0.0685 [0.0216; 0.1969] Random
Overall 5 24 415 0.0602 [0.0407; 0.0883] Fixed 7 26 691 0.0479 [0.0234; 0.0953] Random
Lymphopenia Nivolumab 3 8 185 0.0474 [0.0239; 0.0921] Fixed 3 5 185 0.0276 [0.0115; 0.0647] Fixed
Platelet count decreased Nivolumab 2 5 103 0.0553 [0.0038; 0.4766] Random 2 0 103 0.0113 [0.0016; 0.0761] Fixed
Pembrolizumab 1 11 25 0.4400 1 5 25 0.2000
Overall 3 16 128 0.1354 [0.0225; 0.5159] Random 3 5 128 0.0414 [0.0034; 0.3530] Random
Leukopenia Nivolumab 2 6 162 0.0390 [0.0176; 0.0841] Fixed 2 3 162 0.0331 [0.0124; 0.0850] Fixed

Bold values indicates the classification of the adverse events.