---
title: "Adverse Events | Kisqali®"
description: "Explore the adverse events of KISQALI 400 mg in HR+/HER2- early breast cancer, with data showing a predictable and manageable tolerability profile."
canonical_url: "https://www.kisqali.com/early-breast-cancer/safety-data/adverse-events"
meta:
"og:description": "Explore the adverse events of KISQALI 400 mg in HR+/HER2- early breast cancer, with data showing a predictable and manageable tolerability profile."
"og:title": "Adverse Events"
---
## **Adverse Events**
### **A manageable safety profile with mainly reversible and mostly asymptomatic adverse events. **(1-3)
**KISQALI + AI can help patients experience life with minor disruption on a daily basis. Life on their terms. (1,3-6)**
KISQALI is well tolerated with a consistent safety profile in the broadest range of HR+/HER2– EBC patients, including those with grade 1 disease or no nodal involvement. (2,6)
Adverse events reported in the NATALEE study. (6)
Table comparing the incidence of adverse events (AEs) with KISQALI + AI in two patient populations from the NATALEE studies (n=2525 and n=2442). The table includes percentages for any-grade and grade ≥3 AEs, such as neutropenia, liver-related events, QT prolongation, fatigue, diarrhoea, and others. The data show lower rates of severe AEs in the 2442-patient group receiving KISQALI 400 mg.
| | | | |
| --- | --- | --- | --- |
| | KISQALI + AI, n=2525 | | KISQALI + AI, n=2442 | |
| | Any grade | Grade ≥3 | Any grade | Grade ≥3 |
| | 62.5 | 44.3 | 4.6 | 0.9 |
| | 0.3 | 0.3 | 0 | 0 |
| | 26.4 | 8.6 | 11.2 | 1.7 |
| | 5.3 | 1.0 | 1.4 | 0.6 |
| | 4.3 | 0.3 | 0.7 | 0 |
| | 1.5 | 0 | 0.9 | 0.1 |
| | | | | |
| | 37.3 | 1.0 | 43.3 | 1.3 |
| | 23.3 | 0.2 | 7.8 | 0 |
| | 22.8 | 0.4 | 17.0 | 0.2 |
| | 22.3 | 0.8 | 13.2 | 0.2 |
| | 14.5 | 0.6 | 5.5 | 0.1 |
| | 1.5 | 0.6 | 0.8 | 0.4 |
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\* 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. (6)
Median time to resolution of ≥ grade 3 neutropenia was 0.3 months for KISQALI + AI. (2)
‡ This is a grouped term that includes all preferred terms identified by standardised MedDRA queries for drug-related hepatic disorders. (6)
Median time to resolution of grade 3 or 4 ALT/AST elevation was 0.7 months for KISQALI + AI. (2)
(§) This is a grouped term. (6)
(‖) This is a grouped term that includes all preferred terms identified by standardised MedDRA queries for interstitial lung disease. (6)
(¶) Grouped term that includes all preferred terms identified by standardised MedDRA queries for venous thromboembolism. (6)
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