Takeda Announces Positive Topline Results from Pivotal Phase 2/3 Clinical Trial of TAK-881 in Primary Immunodeficiency Disease (PID)


very common (≥ 1/10): Local reactions (Total, see SmPC for the detailed list of local reactions); common (≥ 1/100 to < 1/10): Headache, Nausea, Abdominal pain, Abdominal pain lower, Abdominal pain upper and Abdominal tenderness, Erythema, Asthenia, Fatigue, Lethargy and Malaise; uncommon (≥ 1/1 000 to < 1/100): Dizziness, Migraine, Tremor, Paraesthesia, Sinus tachycardia and Tachycardia, Blood pressure increased and Hypertension, Diarrhoea, Vomiting, Abdominal distension, Pruritus, Rash, Rash erythematous, Rash macular, Rash maculo-papular and Rash papula, Urticaria, Myalgia, Arthralgia, Limb discomfort and Pain in extremity Back pain, Joint stiffness, Musculoskeletal chest pain, Chills, Oedema, Oedema peripheral and Swelling (systemic), Localised oedema, Peripheral swelling and Skin oedema, Gravitational oedema, Oedema genital, Scrotal swelling and Vulvovaginal swelling, Burning sensation; rare (≥ 1/10 000 to < 1/1 000): Cerebrovascular accident and Ischaemic stroke, Hypotension, Dyspnoea, Groin pain, Haemosiderinuria, Hyperhidrosis, Coombs direct test positive and Coombs test positive.



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