What are the possible side effects (results of trials used to assess safety)?

Table 4 and Table 5 summarize adverse reactions and laboratory abnormalities in the clinical trial.

Table 4. Adverse Reactions (≥10%) in Patients With Newly Diagnosed FLT3-ITD Positive AML Who Received VANFLYTA (With a Difference Between Arms of ≥2% Compared to Placebo) in the Clinical Trial

Source: VANFLYTA Prescribing Information
¹ Including fatalities.
² Includes other related terms.
^a Diarrhea includes colitis, diarrhea, enteritis, enterocolitis, gastroenteritis, and neutropenic colitis.
^b Mucositis includes anal inflammation, anal ulcer, anorectal discomfort, aphthous ulcer, laryngeal inflammation, laryngeal pain, mucosal inflammation, edema mucosal, esophageal pain, esophageal ulcer, esophagitis, oral blood blister, oral disorder, oral mucosa erosion, oral mucosal blistering, oral mucosal erythema, oral pain, oropharyngeal pain, pharyngeal inflammation, proctalgia, proctitis, stomatitis, tongue ulceration, and vaginal ulceration.
^c Sepsis includes acinetobacter infection, bacteremia, bacterial sepsis, corynebacterium bacteremia, device related bacteremia, device related sepsis, enterobacter sepsis, enterococcal bacteremia, enterococcal sepsis, escherichia bacteremia, escherichia sepsis, klebsiella bacteremia, klebsiella sepsis, neutropenic sepsis, pseudomonal bacteremia, pulmonary sepsis, sepsis, septic shock, staphylococcal bacteremia, staphylococcal infection, staphylococcal sepsis, stenotrophomonas sepsis, streptococcal sepsis, and streptococcal bacteremia.
^d Fungal infection includes aspergillosis oral, aspergillus infection, bronchopulmonary aspergillosis, candida infection, candida sepsis, fungal infection, fungal sepsis, fungal skin infection, fusarium infection, gastrointestinal candidiasis, hepatic infection fungal, hepatosplenic candidiasis, lower respiratory tract infection fungal, mucormycosis, oral candidiasis, oral fungal infection, oropharyngeal candidiasis, systemic candida, systemic mycosis, tinea cruris, and vulvovaginal candidiasis.
^e Herpesvirus infection includes disseminated varicella zoster virus infection, genital herpes, herpes simplex, herpesvirus infection, herpes zoster, oral herpes, and varicella zoster virus infection.
^f Hypertransaminasemia includes alanine aminotransferase increased, aspartate aminotransferase increased, transaminases increased, hepatic enzymes increased, and hypertransaminasemia.
^g Eye irritation includes dry eye, eye inflammation, eye irritation, eye pain, eye pruritus, foreign body sensation in eyes, keratitis, and ulcerative keratitis.

Table 5. Select Laboratory Abnormalities (≥10%) That Worsened From Baseline in Patients With Newly Diagnosed FLT3-ITD Positive AML (With a Difference Between Arms of ≥2% Compared to Placebo) in the Clinical Trial

Source: VANFLYTA Prescribing Information
¹ The denominator used to calculate the rate varied from 199 to 260 in VANFLYTA and from 187 to 267 in PLACEBO based on the number of patients with a baseline value and at least one post-treatment value.