Pooled CLL overall outcomes
| Outcome . | Venetoclax, n/N (%) . | Comparator, n/N (%) . | Number of studies included . | RR (95% CrI) . | P(RR > 1), % . |
|---|---|---|---|---|---|
| Total IAE | — | — | — | — | — |
| Grade 3-5 IAEs | 101/516 (19.6%) | 92/516 (17.8%) | 3 | 1.11 (0.74-1.68) | 71.2 |
| Fatal IAEs | 10/516 (1.9%) | 8/516 (1.6%) | 3 | 1.16 (0.53-2.57) | 64.5 |
| Fatal OI∗ | 1/516 (0.2%) | 2/516 (0.4%) | 3 | 0.83 (0.27-2.58) | 37.6 |
| Grade 1-2 neutropenia | 23/516 (4.5%) | 38/516 (7.4%) | 3 | 0.66 (0.37-1.21) | 8.6 |
| Grade 3-5 neutropenia | 261/516 (50.6%) | 228/516 (44.2%) | 3 | 1.07 (0.64-1.74) | 63.4 |
| Total neutropenia | 284/516 (55.0%) | 266/516 (51.6%) | 3 | 1.02 (0.63-1.63) | 54.1 |
| SAE neutropenia | — | — | — | — | — |
| Grade 1-2 febrile neutropenia | — | — | — | — | — |
| Grade 3-5 febrile neutropenia | 20/516 (3.9%) | 29/516 (5.6%) | 3 | 0.76 (0.40-1.49) | 20.5 |
| Total febrile neutropenia | — | — | — | — | — |
| SAE febrile neutropenia | 19/516 (3.7%) | 27/516 (5.2%) | 3 | 0.76 (0.39-1.50) | 20.9 |
| SAE sepsis | 7/516 (1.4%) | 7/516 (1.4%) | 3 | 1.00 (0.39-2.58) | 50.0 |
| Grade 1-2 pneumonia | 9/300 (3%) | 11/300 (3.7%) | 2 | 0.88 (0.39-1.96) | 37.2 |
| Grade 3-5 pneumonia | 30/516 (5.8%) | 30/516 (5.8%) | 3 | 1.01 (0.58-1.74) | 50.9 |
| Total pneumonia | 29/300 (9.7%) | 29/300 (9.7%) | 2 | 0.93 (0.52-1.67) | 39.7 |
| SAE pneumonia | 32/516 (6.2%) | 30/516 (5.8%) | 3 | 1.06 (0.62-1.81) | 58.2 |
| Total upper respiratory tract infections | 56/300 (18.7%) | 43/300 (14.3%) | 2 | 1.23 (0.69-2.08) | 78.5 |
| Total nasopharyngitis | — | — | — | — | — |
| Total bronchitis | — | — | — | — | — |
| Total urinary tract infections | — | — | — | — | — |
| SAE cellulitis | 4/322 (1.2%) | 0/321 (0.0%) | 2 | 1.54 (0.47-5.03) | 76.3 |
| Outcome . | Venetoclax, n/N (%) . | Comparator, n/N (%) . | Number of studies included . | RR (95% CrI) . | P(RR > 1), % . |
|---|---|---|---|---|---|
| Total IAE | — | — | — | — | — |
| Grade 3-5 IAEs | 101/516 (19.6%) | 92/516 (17.8%) | 3 | 1.11 (0.74-1.68) | 71.2 |
| Fatal IAEs | 10/516 (1.9%) | 8/516 (1.6%) | 3 | 1.16 (0.53-2.57) | 64.5 |
| Fatal OI∗ | 1/516 (0.2%) | 2/516 (0.4%) | 3 | 0.83 (0.27-2.58) | 37.6 |
| Grade 1-2 neutropenia | 23/516 (4.5%) | 38/516 (7.4%) | 3 | 0.66 (0.37-1.21) | 8.6 |
| Grade 3-5 neutropenia | 261/516 (50.6%) | 228/516 (44.2%) | 3 | 1.07 (0.64-1.74) | 63.4 |
| Total neutropenia | 284/516 (55.0%) | 266/516 (51.6%) | 3 | 1.02 (0.63-1.63) | 54.1 |
| SAE neutropenia | — | — | — | — | — |
| Grade 1-2 febrile neutropenia | — | — | — | — | — |
| Grade 3-5 febrile neutropenia | 20/516 (3.9%) | 29/516 (5.6%) | 3 | 0.76 (0.40-1.49) | 20.5 |
| Total febrile neutropenia | — | — | — | — | — |
| SAE febrile neutropenia | 19/516 (3.7%) | 27/516 (5.2%) | 3 | 0.76 (0.39-1.50) | 20.9 |
| SAE sepsis | 7/516 (1.4%) | 7/516 (1.4%) | 3 | 1.00 (0.39-2.58) | 50.0 |
| Grade 1-2 pneumonia | 9/300 (3%) | 11/300 (3.7%) | 2 | 0.88 (0.39-1.96) | 37.2 |
| Grade 3-5 pneumonia | 30/516 (5.8%) | 30/516 (5.8%) | 3 | 1.01 (0.58-1.74) | 50.9 |
| Total pneumonia | 29/300 (9.7%) | 29/300 (9.7%) | 2 | 0.93 (0.52-1.67) | 39.7 |
| SAE pneumonia | 32/516 (6.2%) | 30/516 (5.8%) | 3 | 1.06 (0.62-1.81) | 58.2 |
| Total upper respiratory tract infections | 56/300 (18.7%) | 43/300 (14.3%) | 2 | 1.23 (0.69-2.08) | 78.5 |
| Total nasopharyngitis | — | — | — | — | — |
| Total bronchitis | — | — | — | — | — |
| Total urinary tract infections | — | — | — | — | — |
| SAE cellulitis | 4/322 (1.2%) | 0/321 (0.0%) | 2 | 1.54 (0.47-5.03) | 76.3 |
Missing data (—) indicate <2 studies reporting the outcome.
All 3 CLL studies had some risk of bias on the Cochrane risk-of-bias tool for randomized trials version 2 (RoB 2) grading.
The RR was computed using the incidence.