Pooled AML 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 | — | — | — | — | — |
| Fatal IAEs | — | — | — | — | — |
| Fatal OI | — | — | — | — | — |
| Grade 1-2 neutropenia | — | — | — | — | — |
| Grade 3-5 neutropenia | 185/429 (43.1%) | 52/213 (24.4%) | 2 | 1.71 (0.87-3.17) | 94.6 |
| Total neutropenia | — | — | — | — | — |
| SAE neutropenia | 17/429 (4.0%) | 3/213 (1.4%) | 2 | 1.62 (0.60-4.26) | 83.3 |
| Grade 1-2 febrile neutropenia | — | — | — | — | — |
| Grade 3-5 febrile neutropenia | 163/429 (38.0%) | 47/213 (22.1%) | 2 | 1.49 (0.78-2.60) | 90.6 |
| Total febrile neutropenia | — | — | — | — | — |
| SAE febrile neutropenia | 107/429 (24.9%) | 27/213 (12.7%) | 2 | 1.53 (0.71-2.97) | 87.8 |
| SAE sepsis | 24/429 (5.6%) | 16/213 (7.5%) | 2 | 0.80 (0.41-1.59) | 25.5 |
| Grade 1-2 pneumonia | — | — | — | — | — |
| Grade 3-5 pneumonia | — | — | — | — | — |
| Total pneumonia | 94/429 (21.9%) | 50/213 (23.5%) | 2 | 0.96 (0.59-1.63) | 43.3 |
| SAE pneumonia | 65/429 (15.2%) | 39/213 (18.3%) | 2 | 0.87 (0.51-1.56) | 29.8 |
| Total upper respiratory tract infections | — | — | — | — | — |
| Total nasopharyngitis | — | — | — | — | — |
| Total bronchitis | — | — | — | — | — |
| Total urinary tract infections | — | — | — | — | — |
| SAE cellulitis | — | — | — | — | — |
| Outcome . | Venetoclax, n/N (%) . | Comparator, n/N (%) . | Number of studies included . | RR (95% CrI) . | P(RR>1), % . |
|---|---|---|---|---|---|
| Total IAE | — | — | — | — | — |
| Grade 3-5 IAEs | — | — | — | — | — |
| Fatal IAEs | — | — | — | — | — |
| Fatal OI | — | — | — | — | — |
| Grade 1-2 neutropenia | — | — | — | — | — |
| Grade 3-5 neutropenia | 185/429 (43.1%) | 52/213 (24.4%) | 2 | 1.71 (0.87-3.17) | 94.6 |
| Total neutropenia | — | — | — | — | — |
| SAE neutropenia | 17/429 (4.0%) | 3/213 (1.4%) | 2 | 1.62 (0.60-4.26) | 83.3 |
| Grade 1-2 febrile neutropenia | — | — | — | — | — |
| Grade 3-5 febrile neutropenia | 163/429 (38.0%) | 47/213 (22.1%) | 2 | 1.49 (0.78-2.60) | 90.6 |
| Total febrile neutropenia | — | — | — | — | — |
| SAE febrile neutropenia | 107/429 (24.9%) | 27/213 (12.7%) | 2 | 1.53 (0.71-2.97) | 87.8 |
| SAE sepsis | 24/429 (5.6%) | 16/213 (7.5%) | 2 | 0.80 (0.41-1.59) | 25.5 |
| Grade 1-2 pneumonia | — | — | — | — | — |
| Grade 3-5 pneumonia | — | — | — | — | — |
| Total pneumonia | 94/429 (21.9%) | 50/213 (23.5%) | 2 | 0.96 (0.59-1.63) | 43.3 |
| SAE pneumonia | 65/429 (15.2%) | 39/213 (18.3%) | 2 | 0.87 (0.51-1.56) | 29.8 |
| Total upper respiratory tract infections | — | — | — | — | — |
| Total nasopharyngitis | — | — | — | — | — |
| Total bronchitis | — | — | — | — | — |
| Total urinary tract infections | — | — | — | — | — |
| SAE cellulitis | — | — | — | — | — |
Missing data (—) indicate <2 studies reporting the outcome.
Both AML studies had low risk of bias on the Cochrane risk-of-bias tool for randomized trials version 2 (RoB 2) grading of indication for venetoclax.