Summary of safety profile The pooled safety profile has been assessed from two clinical studies involving 443 patients who received Datroway 6 mg/kg body weight for the treatment of breast cancer. 5 months). 4%). 1%). 7% of patients and were due to ILD/pneumonitis, dyspnoea and sepsis.
1%). 6%. 0%). 0%. 4%). 6%. 1%). Tabulated list of adverse reactions Table 3 presents adverse reactions reported with Datroway. Adverse reactions are listed by System Organ Class and frequency category. The adverse reaction frequencies are based on all-cause adverse event frequencies, where a proportion of the events for an adverse reaction may have other causes than datopotamab deruxtecan, such as the disease, other medicinal products or unrelated causes.
The severity of adverse drug reactions was assessed based on the Common Terminology Criteria for Adverse Events (CTCAE), defining Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening, and Grade 5 = death.
Frequency categories 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. 9 Table 3: Adverse reactions in patients treated with datopotamab deruxtecan 6 mg/kg System organ class Frequency category Adverse reactions Infections and infestations Very common COVID-19a Common urinary tract infection, pneumoniab, sepsis Blood and lymphatic system disorders Very common anaemia, neutropeniac Common leukopenia Immune system disorders Not known anaphylactic reaction Metabolism and nutrition disorders Very common decreased appetite Nervous system disorders Common dysgeusia Eye disorders Very common keratitisd, dry eye Common conjunctivitise, blurred vision, lacrimation increased, blepharitis, meibomian gland dysfunction, photophobia Uncommon visual impairment Respiratory, thoracic and mediastinal disorders Common ILD/pneumonitisf, dyspnoea Gastrointestinal disorders Very common stomatitisg, vomiting, nausea, diarrhoea, constipation Common dry mouth Skin and subcutaneous tissue disorders Very common alopecia, rashh Common pruritus, dry skin, skin hyperpigmentationi, madarosis General disorders and administration site conditions Very common fatiguej Investigations Very common aspartate aminotransferase increased, alanine aminotransferase increased Injury, poisoning and procedural complications Common infusion-related reactionk a Including COVID-19, COVID-19 pneumonia, SARS-CoV-2 test positive.
b Including pneumonia, lower respiratory tract infection and lower respiratory tract infection fungal. c Including neutropenia and neutrophil count decreased. d Including keratitis, punctate keratitis and ulcerative keratitis. e Including conjunctivitis, conjunctival disorder, conjunctival hyperaemia and conjunctival irritation.
f Including interstitial lung disease and pneumonitis. g Including stomatitis, aphthous ulcer, glossitis, mouth ulceration, odynophagia, oral pain, oropharyngeal pain and pharyngeal inflammation. h Including rash, erythematous rash, maculo-papular rash and pruritic rash.
i Including skin hyperpigmentation and skin discolouration. j Including fatigue and asthenia. k Infusion-related reaction includes as any reaction (infusion-related reaction, pruritus and rash) occurring within the same day as Datroway infusion.
6% were adjudicated as drug-related ILD/pneumonitis by independent review. 9%). 9% of patients. 9% of patients. 2% of patients. 8). 8% were Grade 3. 9% were Grade 3. 1 months […]