At 4 years, KISQALI® 400 mg had a predictable, manageable, and reversible safety profile^*1,2

*The majority of adverse events were transient, manageable, and reversible with dose reduction or interruption.²
†This is a grouped term that combines neutropenia and neutrophil count decreased.¹ Median time to resolution of ≥grade 3 neutropenia was 0.3 months for KISQALI® + NSAI.²
‡This is a grouped term that includes all preferred terms identified by standardised MedDRA queries for drug-related hepatic disorders Liver-related AEs were predominately
ALT/AST elevations without concomitant bilirubin increase.¹
Median time to resolution of grade 3 or 4 ALT/AST elevation was 0.7 months for KISQALI® + NSAI.²
§This is a grouped term.¹
IIThis is a grouped term that includes all preferred terms identified by standardised MedDRA queries for interstitial lung disease.¹
¶Grouped term that includes all preferred terms identified by standardised MedDRA queries for venous thromboembolism.¹
**Instrumental ADLs include preparing meals, shopping, using the telephone, managing money. Self-care ADLs include bathing, dressing/undressing, using the toilet, taking medications, and not bedridden.⁴
***Fatigue defined as: A disorder characterised by a state of generalised weakness with a pronounced inability to summon sufficient energy to accomplish daily activities.⁴
† †Instrumental ADLs include preparing meals, shopping, using the telephone, managing money. Self-care ADLs include bathing, dressing/undressing, using the toilet, taking medications, and not bedridden.⁴

AE, adverse event; AESI, adverse event of special interest; ALT, alanine aminotransferase; AST, aspartate aminotransferase; ECG, electrocardiogram; MedDRA, Medical Dictionary for Regulatory Activities; NSAI, non-steroidal aromatase inhibitor; QT, interval; VTE, venous thromboembolism.