8%). 92 patient years) are listed in Table 2 by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), and uncommon (≥ 1/1 000 to < 1/100). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Selected adverse reactions are further decribed in following Table 2. Table 2 Adverse reactions System Organ Class Preferred Term Frequency Category Infections and infestations Influenza Very common Urinary tract infection Common Immune system disorders Hypersensitivity including urticaria and rasha Very common Metabolism and nutrition disorders Decreased appetite Very common Hypertriglyceridemia Common Very low density lipoprotein increased Common Nervous system disorders Headache Very common Respiratory, thoracic and mediastinal disorders Oropharyngeal pain Very common Gastrointestinal disorders Nausea Very common Diarrhoea Very common Vomiting Very common Abdominal upper pain Common Abdominal pain Common Hepatobiliary disorders ALT increased Very common AST increased Very common GGT increased Common Musculoskeletal and connective tissue disorders Back pain Very common Muscle spasms Very common 8 System Organ Class Preferred Term Frequency Category Reproductive system and breast disorders Dysmenorrhoea Common General disorders and administration site conditions Fatigue Very common Investigations BNP increasedb Common Weight decreasedc Very common a Cases have been reported in the post-marketing setting with unknown frequency.
bBased on laboratory evaluations with values > 200 pg/mL. cBased on weight measured in the clinic with on-treatment weight loss ≥ 5%. ALT=alanine aminotransferase; AST=aspartate aminotransferase; BNP=B-type natriuretic peptide; GGT=gamma glutamyltransferase.
8% of patients. 8% of the events occurred within the first 12 weeks of therapy. 9% of patients. 8% of all Skyclarys-treated patients. One patient (2%) was discontinued for aminotransferase elevation per protocol. 7% experiencing elevations ≥ 5 × the ULN.
Elevations of ≥ 3 × the ULN were generally transient and reversible, with 80% of these patients experiencing maximal levels within the first 12 weeks of treatment. None of these patients had ALT or AST levels ≥ 3 × the ULN at the withdrawal visit.
Mean values generally decreased towards baseline with continued treatment or after interruption in therapy. 5 × the ULN. Elevation of BNP In the randomized, double-blind, placebo-controlled study, increases in laboratory evaluations of BNP were observed in patients treated with Skyclarys.
Mean BNP values were elevated at Week 4, and remained elevated through Week 48, with peak mean elevations at Week 24. Mean BNP values remained below the ULN (< 100 pg/mL). 9% of patients had BNP values that exceeded 200 pg/mL while on treatment.
There were no discontinuations due to BNP elevation. 0% of patients. At Week 48 in the Skyclarys treatment group, mean LDL increased by approximately 25 mg/dL and mean HDL decreased by approximately 5 mg/dL. After withdrawal of Skyclarys, mean LDL and HDL levels returned to baseline.
9% of patients treated with placebo. No serious adverse reactions or discontinuations due to decreased appetite or weight decrease were reported in either treatment group. Decrease in body weight was observed after Week 24. 108 kg) in the placebo group after 48 weeks of treatment.
7% of placebo-treated patients. […]