Table 3.
Incidence of select AEs of clinical importance over time
| Time window (duration of time window), wk∗ | 0-24 (24) N = 725 | 25-48 (24) n = 510 | 49-96 (48) n = 367 | 97-144 (48) n = 213 | 145-192 (48) n = 150 | 193-240 (48) n = 109 | 241-288 (48) n = 93 | ≥289 n = 64 |
|---|---|---|---|---|---|---|---|---|
| n (%) | ||||||||
| Any AE | 663 (91.4) | 371 (72.7) | 280 (76.3) | 159 (74.6) | 99 (66.0) | 60 (55.0) | 51 (54.8) | 20 (31.3) |
| All infections (SOC) | 263 (36.3) | 133 (26.1) | 121 (33.0) | 64 (30.0) | 38 (25.3) | 22 (20.2) | 20 (21.5) | 8 (12.5) |
| Opportunistic infections (similar PTs) | 13 (1.8) | 7 (1.4) | 9 (2.5) | 8 (3.8) | 3 (2.0) | 0 | 4 (4.3) | 1 (1.6) |
| Malignancies (similar PTs) | 38 (5.2) | 21 (4.1) | 23 (6.3) | 13 (6.1) | 12 (8.0) | 3 (2.8) | 7 (7.5) | 3 (4.7) |
| AML/malignant transformation (similar PTs) | 12 (1.7) | 1 (0.2) | 6 (1.6) | 1 (0.5) | 2 (1.3) | 0 | 0 | 0 |
| Nonmelanoma skin cancer (similar PTs) | 9 (1.2) | 14 (2.7) | 10 (2.7) | 5 (2.3) | 3 (2.0) | 1 (0.9) | 3 (3.2) | 3 (4.7) |
| MACE (similar PTs) | 20 (2.8) | 9 (1.8) | 18 (4.9) | 8 (3.8) | 4 (2.7) | 1 (0.9) | 2 (2.2) | 1 (1.6) |
| Thromboembolism (SMQ) | 25 (3.4) | 12 (2.4) | 19 (5.2) | 8 (3.8) | 6 (4.0) | 2 (1.8) | 3 (3.2) | 2 (3.1) |
Data cutoff: 3 December 2021.
PT, preferred term; SMQ, standardized MedDRA query.
∗
n in the column heading represents the number of patients who were still receiving treatment at the beginning of each time window and is used as the denominator to calculate percent of patients with AEs. A patient can appear multiple times in this table because it captures the presence of an event during a specific time window. Events included could be of any severity.