Table 2.
The incidence of adverse events in any grade or grade ≥3 for patients with R/R B-NHL.
| AEs | Treatment | Any grade | Grade ≥3 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Included study | Event | Total patients | Pooled rate(95% Cl) | p-value | Included study | Event | Total patients | Pooled rate(95% Cl) | p-value | |||
| Hematological | ||||||||||||
| Neutropenia | Copanlisib | 3 | 59 | 242 | 0.2278[0.1297;0.3440] | P=0.2661 | 2 | 42 | 209 | 0.1801[0.0782;0.3124] | P=0.1811 | |
| Including copanlisib plus rituximab | 2 | 66 | 328 | 0.1067[0.0043;0.3190] | 2 | 50 | 328 | 0.0936[0.0067;0.2645] | ||||
| Overall | 5 | 125 | 570 | 0.1899[0.1202;0.2711] | 4 | 92 | 537 | 0.1475[0.0843;0.2246] | ||||
| Decreased platelet count | Copanlisib | 3 | 27 | 188 | 0.1436[0.0973;0.1972] | P=0.7445 | 2 | 7 | 155 | 0.0435[0.0100;0.0769] | P=0.5806 | |
| Including copanlisib plus rituximab | 2 | 52 | 328 | 0.3887[0.0770;0.7655] | 2 | 10 | 328 | 0.0440[0.0000;0.1109] | ||||
| Overall | 5 | 79 | 516 | 0.2101[0.1249;0.3105] | 4 | 17 | 483 | 0.0281[0.0132;0.0429] | ||||
| Non-hematological | ||||||||||||
| Fatigue | Copanlisib | 4 | 75 | 251 | 0.3276[0.2354;0.4557] | P<0.0001 | 2 | 4 | 209 | 0.0190[0.0050;0.0419] | P=0.2762 | |
| Including copanlisib plus rituximab | 2 | 52 | 328 | 0.2828[0.1143;0.6994] | 2 | 5 | 328 | 0.0143[0.0043;0.0299] | ||||
| Overall | 6 | 127 | 579 | 0.3033[0.2038;0.4513] | 4 | 9 | 537 | 0.0160[0.0072;0.0284] | ||||
| Diarrhea | Copanlisib | 5 | 95 | 264 | 0.3594[0.3015;0.4172] | P=0.7627 | 3 | 13 | 222 | 0.0289[0.0001;0.1058] | P=0.8811 | |
| Including copanlisib plus rituximab | 2 | 113 | 328 | 0.3437[0.2925;0.3949] | 2 | 17 | 328 | 0.0514[0.0302;0.0779] | ||||
| Overall | 7 | 208 | 592 | 0.3506[0.3122;0.3889] | 5 | 30 | 550 | 0.0509[0.0341;0.0708] | ||||
| Nausea | Copanlisib | 4 | 71 | 251 | 0.3580[0.2117;0.5042] | P=0.3357 | 2 | 2 | 209 | 0.0086[0.0000;0.0284] | P=0.6445 | |
| Including copanlisib plus rituximab | 2 | 80 | 328 | 0.4053[0.1214;0.6892] | 2 | 2 | 328 | 0.0000[0.0000;0.0019] | ||||
| Overall | 6 | 151 | 579 | 0.3498[0.2505;0.4491] | 4 | 4 | 537 | 0.0000[0.0000;0.0053] | ||||
| Pneumonia | Copanlisib | 2 | 25 | 175 | 0.1403[0.0912;0.1972] | P=0.9685 | 1 | 12 | 142 | 0.1056 | _ | |
| Including copanlisib plus rituximab | 2 | 45 | 328 | 0.1175[0.0806;0.1590] | 2 | 21 | 328 | 0.0610[0.0352;0.0869] | ||||
| Overall | 4 | 70 | 503 | 0.1261[0.0959;0.1591] | 3 | 33 | 470 | 0.0703[0.0472;0.0933] | ||||
| Hyperglycemia | Copanlisib | 5 | 136 | 264 | 0.6369[0.4379;0.9264] | P<0.0001 | 4 | 87 | 231 | 0.3761[0.3148;0.4394] | P<0.0001 | |
| Including copanlisib plus rituximab | 2 | 228 | 328 | 0.6993[0.6513;0.7508] | 2 | 185 | 328 | 0.5641[0.5101;0.6173] | ||||
| Overall | 7 | 364 | 592 | 0.6675[0.5399;0.8254] | 6 | 272 | 559 | 0.4514[0.5101;0.6173] | ||||
| Hypertension | Copanlisib | 5 | 106 | 264 | 0.4969[0.3045;0.6898] | P=0.0368 | 4 | 66 | 231 | 0.2757[0.2168;0.3384] | P=0.0074 | |
| Including copanlisib plus rituximab | 2 | 161 | 328 | 0.4789[0.2664;0.6950] | 2 | 131 | 328 | 0.3934[0.3380;0.4502] | ||||
| Overall | 7 | 267 | 592 | 0.4857[0.3604;0.6118] | 6 | 197 | 559 | 0.3507[0.2576;0.4492] | ||||