The ADRs listed in Table 18 were all adverse events which occurred at an incidence of 5% ≥ in the MABTHERA-treated group. The safety profile from long-term use of MABTHERA to treat GPA/MPA has not been established. Table 18 Adverse Drug Reactions occurring in 5% of patients receiving MABTHERA, ≥ and at a higher frequency than cyclophosphamide, in the pivotal study at MABTHERA CYC Adverse reactions n =99 n 98 Blood and lymphatic system disorders Thrombocytopenia 7% 3% Gastrointestinal disorders Diarrhoea 18% 12% Dyspepsia 6% 5% Constipation 5% 1% General disorders and administration site conditions Peripheral oedema 16% 9% Immune system disorders Infusion related reactions 5% 2% Infections and infestations Urinary tract infection 7% 3% Bronchitis 5% 2% Herpes zoster 5% 2% Nasopharyngitis 5% 4% Investigations Decreased haemoglobin 6% 4% Metabolism and nutrition disorders Hypokalaemia 5% 2% Musculoskeletal and connective tissue disorders 18% 17% Muscle spasm 15% 10% Arthralgia Back pain 10% 6% 5% 4% Muscle weakness 5% 0% Musculoskeletal pain Pain in extremities 5% 3% Nervous system disorders Dizziness 10% 9% Tremor 10% 6% Psychiatric disorders Insomnia 14% 13% Respiratory, thoracic and mediastinal disorders 12% 11% Cough 11% 9% Dyspnoea 11% 6% Epistaxis 6% 2% Nasal congestion
The ADRs listed in Table 18 were all adverse events which occurred at an incidence of ≥ 5% in the MABTHERA-treated group. The safety profile from long-term use of MABTHERA to treat GPA/MPA has not been established. Table 18 Adverse Drug Reactions occurring in ≥ 5% of patients receiving MABTHERA, and at a higher frequency than cyclophosphamide, in the pivotal study at Adverse reactions MABTHERA n =99 CYC n 98 Blood and lymphatic system disorders Thrombocytopenia 7% 3% Gastrointestinal disorders Diarrhoea Dyspepsia Constipation 18% 6% 5% 12% 5% 1% General disorders and administration site conditions Peripheral oedema 16% 9% Immune system disorders Infusion related reactions 5% 2% Infections and infestations Urinary tract infection Bronchitis Herpes zoster Nasopharyngitis 7% 5% 5% 5% 3% 2% 2% 4% Investigations Decreased haemoglobin 6% 4% Metabolism and nutrition disorders Hypokalaemia 5% 2% Musculoskeletal and connective tissue disorders Muscle spasm Arthralgia Back pain Muscle weakness Musculoskeletal pain Pain in extremities 18% 15% 10% 5% 5% 5% 17% 10% 6% 4% 0% 3% Nervous system disorders Dizziness Tremor 10% 10% 9% 6% Psychiatric disorders Insomnia 14% 13% Respiratory, thoracic and mediastinal disorders Cough Dyspnoea Epistaxis Nasal congestion 12% 11% 11% 6% 11% 9% 6% 2%
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