Exemptia Adverse Reactions

Adverse Events Observed in CHL's Clinical Trial Were: Dyspnoea, Fungal infection, Gastritis, Headache, Injection site reaction, Joint swelling, Oligomenorrhoea, Pollakiuria, Polymenorrhoea, Pulmonary tuberculosis, Pyrexia, Rash, Urinary tract infection, Vomiting, Abdominal discomfort, Abdominal pain, Accelerated hypertension, Arthralgia, Asthenia, Body tinea, Chest pain, Cough, Diarrhoea and Dyspepsia.
Undesirable Effects: The most commonly reported undesirable effects in patients taking Adalimumab include: infections (such as nasopharyngitis, upper respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling), headache and musculoskeletal pain. Some fatal infections (including sepsis, opportunistic infections, TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have been reported. Serious reactions such as haematological, neurological and autoimmune reactions were also reported. Some rare reactions include pancytopenia, aplastic anaemia, central and peripheral demyelinating events, lupus, lupus-related conditions and Stevens-Johnson syndrome. (See Table 5.)

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