Table 2.

Adverse events and serious adverse events (safety population).

All events

Any event: n = 64 (71.9%)

Any event leading to discontinuation of the drug: n = 1 (1.1%)

PML: none

Death: none

Infusion reactions (n = 40); 8.7%

(i) Mild reaction during first cycle (n = 19)

(ii) Mild reaction during second cycle (n = 9)

(iii) Mild reaction during third cycle (n = 4)

(iv) Mild reaction during ≥ fourth cycle (n = 8)

Infections (n = 14); 15.7%

(i) Urinary tract infections: n = 9

(ii) Upper and lower respiratory tract infections: n = 3

(iii) Flu: n = 2

Dermatological adverse events (n = 4) – 4.5%

(i) Pityriasis rosea: n = 3

(ii) Seborrheic dermatitis: n = 1

Fatigue (n = 3); 3.4%

Laboratory abnormalities (n = 3); 3.4%

(i) Lymphopenia (ALC = 665): n = 1

(ii) Eosinophilia (7%): n = 1

(iii) Anemia: n = 1

GI (nausea, abdominal pain, bloating, flatulence): n = 2

Weight gain: n = 2

Sexual dysfunction: n = 2

Hip fracture: n = 2

Headache: n = 2

Arthralgia: n = 1

Paresthesia in fingers: n = 1

Hair loss: n = 1

Loss of appetite: n = 1

Urinary urgency: n = 1

Serious adverse events requiring hospitalizations and surgical interventions (n = 2); 2.2%

(i) Increase in the size of a preexisting meningioma with central cystic formation and enhancement 21 months after initiating rituximab therapy: n = 1

(ii) Fungal vaginal infection, vaginitis, pyoderma gangrenosum vaginalis, perianal abscess with fistula formation 38 months after initiating rituximab therapy: n = 1

PML = progressive multifocal leukoencephalopathy; ALC = acute lymphocytic count; GI = gastrointestinal.