Summary of the safety profile Nivolumab in combination with relatlimab is associated with immune-related adverse reactions (see “Description of selected adverse reactions” below). 4. The most common adverse reactions are fatigue (44%), musculoskeletal pain (34%), rash (30%), diarrhoea (30%), arthralgia (29%), pruritus (28%), headache (21%), nausea (21%), cough (18%), hypothyroidism (18%), decreased appetite (16%), abdominal pain (16%), vitiligo (14%), urinary tract infection (14%), pyrexia (13%), constipation (13%), upper respiratory tract infection (12%), dyspnoea (12%), vomiting (12%), dizziness (10%), and oedema (10%).
1%). Incidences of Grade 3-5 adverse reactions in patients with advanced (unresectable or metastatic) melanoma were 47% for nivolumab in combination with relatlimab and 38% for nivolumab treated patients. Tabulated summary of adverse reactions The safety of nivolumab in combination with relatlimab has been evaluated in 355 patients with advanced (unresectable or metastatic) melanoma (study CA224047).
94 months, are presented in Table 2. The frequencies included above and in Table 2 are based on all-cause adverse event frequencies. These reactions are presented by system organ class and by frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Table 2:
Adverse reactions in clinical studies Infections and infestations Very common urinary tract infection, upper respiratory tract infection Common folliculitis Blood and lymphatic system disorders Very common anaemiaa, lymphopaeniaa, leucopaeniaa, neutropaeniaa Common thrombocytopaeniaa, eosinophilia Uncommon haemolytic anaemia Endocrine disorders Very common hypothyroidism Common adrenal insufficiency, hypophysitis, hyperthyroidism, thyroiditis Uncommon hypopituitarism, hypogonadism Metabolism and nutrition disorders Very common decreased appetite Common diabetes mellitus, hypoglycaemiaa, weight decreased, hyperuricaemia, hypoalbuminaemia, dehydration Psychiatric disorders Common confusional state Nervous system disorders Very common dizziness, headache Common peripheral neuropathy, dysgeusia Uncommon encephalitis, Guillain-Barré syndrome, optic neuritis, myasthenia gravis, Myocarditis- Myositis-Myasthenia Gravis Overlap Syndromec Eye disorders Common uveitis, visual impairment, dry eye, increased lacrimation Uncommon Vogt-Koyanagi-Harada disease, ocular hyperaemia Cardiac disorders Common myocarditis Uncommon pericardial effusion Vascular disorders Common phlebitis Respiratory, thoracic and mediastinal disorders Very common dyspnoea, cough Common pneumonitisb, pleural effusion, nasal congestion Uncommon asthma Gastrointestinal disorders Very common diarrhoea, vomiting, nausea, abdominal pain, constipation Common colitis, pancreatitis, gastritis, dysphagia, stomatitis, dry mouth Uncommon oesophagitis Rare pancreatic exocrine insufficiency Not known coeliac disease Hepatobiliary disorders Common hepatitis Uncommon cholangitis 12 Skin and subcutaneous tissue disorders Very common rash, vitiligo, pruritus Common alopecia, lichenoid keratosis, psoriasis, urticaria, photosensitivity reaction, dry skin Uncommon pemphigoid Musculoskeletal and connective tissue disorders Very common musculoskeletal pain, arthralgia Common arthritis, muscle spasms, muscular weakness Uncommon myositis, Sjogren’s Syndrome, polymyalgia rheumatica, rheumatoid arthritis, systemic lupus erythematosus Renal and urinary disorders Common renal failure, proteinuria Uncommon nephritis Reproductive system and breast disorders Uncommon azoospermia General disorders and administration site conditions Very common oedema, fatigue, pyrexia Common influenza-like illness, chills Rare serositis Investigations Very common increased ASTa, increased ALTa, hyponatraemiaa, increased creatininea, increased alkaline phosphatasea, hypocalcaemiaa, hypomagnesaemiaa, hyperkalaemiaa, hypercalcaemiaa, hypokalaemiaa, hypernatraemiaa, increased bilirubina Common hypermagnesaemiaa, troponin increased, gamma-glutamyl transferase increased, blood lactate dehydrogenase increased, lipase increased, amylase increased, c-reactive protein increased Uncommon red blood cell sedimentation rate increased Injury, poisoning and procedural complications Common infusion-related reaction a Frequencies of laboratory terms reflect the proportion of patients who experienced a worsening from baseline in laboratory measurements.
b Fatal case has been reported in the clinical study. 4). 1% of patients. 8%. 28% of patients. 4). 0+). 7% of patients and required high […]