Table 4

 Adverse events observed in ⩾1% of patients with rheumatoid arthritis

Pooled phase II study populationPhase III study population
MTX+placebo n = 189Rituximab+MTX n = 232MTX+placebo n = 209Rituximab+MTX n = 308
Values are n (%).
Data from http://www.emea.eu.int/humandocs/Humans/EPAR/mabthera/mabthera.htm.
*In addition to the events tabulated above, medically relevant events reported uncommonly in the rituximab-treated population and considered potential to treatment include the following. General disorders: generalised oedema; respiratory disorders: bronchospasm, wheezing, laryngeal oedema; skin and subcutaneous disorders: angioneurotic oedema, generalised pruritus; immune system disorders: anaphylaxis, anaphylactoid reaction.
Acute infusion reactions*
Hypertension10 (5)22 (9)11 (5)21 (7)
Nausea14 (7)19 (8)5 (2)22 (7)
Rash6 (3)18 (8)9 (4)17 (6)
Fever1 (<1)12 (5)7 (3)15 (5)
Pruritus1 (<1)14 (6)4 (2)12 (4)
Urticaria02 (<1)3 (1)10 (3)
Rhinitis2 (1)6 (3)4 (2)8 (3)
Throat irritation05 (2)06 (2)
Hot flush4 (2)2 (<1)06 (2)
Hypotension11 (6)10 (4)1 (<1)5 (2)
Chills3 (2)13 (6)6 (3)3 (<1)
Infections and infestations
Any infection56 (30)85 (37)78 (37)127 (41)
Urinary tract infections8 (4)14 (6)17 (8)15 (5)
Upper respiratory tract28 (15)31 (13)26 (12)48 (16)
Lower respiratory tract10 (5)9 (4)5 (2)8 (3)
General disorders
Asthenia03 (1)1 (<1)6 (2)
Gastrointestinal disorders
Dyspepsia3 (2)9 (4)07 (2)
Abdominal pain upper3 (2)7 (3)1 (<1)4 (1)
Metabolism and nutritional disorders
Hypercholesterolaemia1 (<1)3 (1)06 (2)
Musculoskeletal disorders
Arthralgia or musculoskeletal pain8 (4)18 (7)6 (3)17 (7)
Muscle spasms01 (<1)2 (1)7 (2)
Osteoarthritis1 (<1)4 (2)06 (2)
Nervous system
Paraesthesia2 (1)4 (2)1 (<1)8 (3)
Migraine04 (2)2 (1)5 (2)