Table 4.
Summary of AEs, SAEs, AESIs, and ADRs reported during the short- and long-term treatment in patients with follicular lymphoma receiving R-chemo (n (%))
| Safety | Short/long-term (days) | Total (n = 31) | Age (years) | FLIPI risk | ECOG | ||||
|---|---|---|---|---|---|---|---|---|---|
| ≤60 (n = 23) | 60–80 (n = 8) | Low (n= 11) | Intermediate (n = 11) | High (n = 9) | >2 (n = 2) | ≤2 (n = 29) | |||
| AE (any grade) | ≤120 | 28 (90.3) | 21 (91.3) | 7 (87.5) | 10 (90.9) | 11 (100) | 7 (77.8) | 0 | 28 (96.5) |
| >120 | 4 (12.9) | 3 (13.0) | 1 (12.5) | 1 (9.1) | 1 (9.1) | 2 (22.2) | 0 | 4 (13.8) | |
| AE (grade 3–5) | ≤120 | 14 (45.2) | 9 (39.1) | 5 (62.5) | 3 (27.2) | 6 (54.5) | 5 (55.5) | 0 | 14 (48.3) |
| >120 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| SAE | ≤120 | 4 (12.9) | 3 (13.0) | 1 (12.5) | 1 (9.1) | 1 (9.1) | 2 (22.2) | 0 | 4 (13.8) |
| >120 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| AESI | ≤120 | 7 (22.6) | 4 (17.4) | 3 (37.5) | 2 (18.2) | 2 (18.2) | 3 (33.3) | 0 | 7 (24.1) |
| >120 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| ADR | ≤120 | 18 (58.1) | 12 (52.2) | 6 (75.0) | 6 (54.5) | 7 (63.6) | 5 (55.5) | 0 | 18 (62.1) |
| >120 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Short-term (≤120 days): Data collected 120 days after the last rituximab dose administration; long-term (>120 days): Data collected from 120 days after the last rituximab dose administration to the study end. AE: Adverse event; SAE: Severe adverse event; AESI: Adverse event of special interest; ADR: Adverse drug reaction; Chemo: Chemotherapy; R: Rituximab; IPI: International prognostic index; FLIPI: Follicular lymphoma international prognostic index; ECOG: Eastern cooperative oncology group performance status.