Adverse events occurring during rituximab therapy and throughout the 1-year follow-up period
| Event . | n . |
|---|---|
| Total deaths | 3 |
| Deaths caused by cerebral infarction and heart involvement | 1 |
| Deaths due to cardiac TTP | 2 |
| Chest pain | |
| Chest pain during IMP infusion | 1 |
| Chest pain following IMP infusion | 5 (1 associated with troponin T > 0.05) |
| Chest pain not related to IMP | 2 |
| Infections | |
| Infections following rituximab infusion (up to 1-y follow-up) | 26 |
| Viral infections | 10 |
| Bacterial infections | 1 (Clostridium difficile) |
| Skin infections | 4 (2 Staphylococcus aureus; 1 fungal) |
| Cellulitis | 2 |
| Urinary tract infections | 6 (3 E coli, twice in same patient; 1 Enterococcus) |
| Infections due to infusion lines | 3 |
| Infections prior to rituximab infusion/unrelated to rituximab | 10 (1 E coli; S aureus) |
| Neurologic | |
| TIA | 4 (3 occurring sequentially in same patient) |
| Numbness in limb | 4 (2 in same patient) |
| Depression after discharge | 3 |
| Sensory/motor abnormalities not related to IMP | 5 |
| Headaches | 4 |
| Hematologic | |
| Reduced neutrophil count (< 1.5 × 109/L) | 3 (transitory, incidental, no infections) |
| Reduced platelet count | 1 |
| Vascular | |
| Deep vein thrombosis | 1 |
| Increased blood pressure | 2 |
| Hypotensive | 2 |
| Other vascular | 2 |
| Reproductive | |
| Miscarriage unrelated to rituximab | 1 |
| Miscarriage (partner's) | 1 |
| Stillbirth (partner's) | 1 |
| Other events | |
| Joint pain possibly related to rituximab | 5 |
| Skin rash (in remission) possibly related to rituximab | 3 |
| Hair loss/thinning possibly related to rituximab | 2 |
| Temperature 38°C | 3 |
| Event . | n . |
|---|---|
| Total deaths | 3 |
| Deaths caused by cerebral infarction and heart involvement | 1 |
| Deaths due to cardiac TTP | 2 |
| Chest pain | |
| Chest pain during IMP infusion | 1 |
| Chest pain following IMP infusion | 5 (1 associated with troponin T > 0.05) |
| Chest pain not related to IMP | 2 |
| Infections | |
| Infections following rituximab infusion (up to 1-y follow-up) | 26 |
| Viral infections | 10 |
| Bacterial infections | 1 (Clostridium difficile) |
| Skin infections | 4 (2 Staphylococcus aureus; 1 fungal) |
| Cellulitis | 2 |
| Urinary tract infections | 6 (3 E coli, twice in same patient; 1 Enterococcus) |
| Infections due to infusion lines | 3 |
| Infections prior to rituximab infusion/unrelated to rituximab | 10 (1 E coli; S aureus) |
| Neurologic | |
| TIA | 4 (3 occurring sequentially in same patient) |
| Numbness in limb | 4 (2 in same patient) |
| Depression after discharge | 3 |
| Sensory/motor abnormalities not related to IMP | 5 |
| Headaches | 4 |
| Hematologic | |
| Reduced neutrophil count (< 1.5 × 109/L) | 3 (transitory, incidental, no infections) |
| Reduced platelet count | 1 |
| Vascular | |
| Deep vein thrombosis | 1 |
| Increased blood pressure | 2 |
| Hypotensive | 2 |
| Other vascular | 2 |
| Reproductive | |
| Miscarriage unrelated to rituximab | 1 |
| Miscarriage (partner's) | 1 |
| Stillbirth (partner's) | 1 |
| Other events | |
| Joint pain possibly related to rituximab | 5 |
| Skin rash (in remission) possibly related to rituximab | 3 |
| Hair loss/thinning possibly related to rituximab | 2 |
| Temperature 38°C | 3 |
TTP indicates thrombocytopenic purpura; IMP, investigational medicinal product; and TIA, transient ischaemic attack.