Safety and Efficacy of Subcutaneous Rituximab in Previously Untreated Patients with CD20+ Diffuse Large B-Cell Lymphoma or Follicular Lymphoma: Results from an Italian Phase IIIb Study
Table 3
Overall summary of adverse events. Data are number (%) of patients.
All patients (N = 158)
DLBCL (N = 72)
FL (N = 86)
TEAEs
134 (84.8%)
61 (84.7%)
73 (84.9%)
Treatment-emergent SAEs
49 (31.0%)
26 (36.1%)
23 (26.7%)
ARRs
10 (6.3%)
3 (4.2%)
7 (8.1%)
Cutaneous and soft tissue ARRs (localised)
8 (5.1%)
1 (1.4%)
7 (8.1%)
Cutaneous and soft tissue ARRs (nonlocalised)
2 (1.3%)
2 (2.8%)
0 (0.0%)
Grade ≥3 TEAEs
74 (46.8%)
37 (51.4%)
37 (43.0%)
Grade ≥3 treatment-emergent SAEs
48 (30.4%)
25 (34.7%)
23 (26.7%)
Grade ≥3 ARRs
0 (0.0%)
0 (0.0%)
0 (0.0%)
Grade ≥3 infusion/injection-related reactions
0 (0.0%)
0 (0.0%)
0 (0.0%)
TEAEs leading to rituximab interruption or delay
33 (20.9%)
11 (15.3%)
22 (25.6%)
TEAEs leading to rituximab dose discontinuation
8 (5.1%)
2 (2.8%)
6 (7.0%)
TEAEs leading to chemotherapy dose modification
3 (1.9%)
2 (2.8%)
1 (1.2%)
TEAEs leading to chemotherapy dose discontinuation
4 (2.5%)
1 (1.4%)
3 (3.5%)
TEAEs leading to death
2 (1.3%)
2 (2.8%)
0 (0.0%)
N: number of patients; DLBCL: diffuse large B-cell lymphoma; FL: follicular lymphoma; TEAE: treatment-emergent adverse event; SAE: serious adverse event; ARR: administration-related reaction.
