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AEs with an incidence of ≥ 10% in either arm are shown.
| TAGRISSO (n=279) | gefitinib / erlotinib (n=277) | |||
|---|---|---|---|---|
| Any grade | Grade ≥3 | Any grade | Grade ≥ 3 | |
| Any AE | 98% | 32% | 98% | 41% |
| Rash or acne† | 58% | 1% | 78% | 7% |
| Diarrhoea‡ | 58% | 2% | 57% | 2% |
| Dry skin† | 36% | <1% | 36% | 1% |
| Paronychia† | 35% | <1% | 33% | 1% |
| Stomatitis | 29% | <1% | 20% | <1% |
| Decreased appetite | 20% | 3% | 19% | 2% |
| Pruritus | 17% | <1% | 16% | 0 |
| Cough | 16% | 0 | 15% | <1% |
| Constipation | 15% | 0 | 13% | 0 |
| Nausea‡ | 14% | 0 | 19% | 0 |
| Fatigue | 14% | <1% | 12% | <1% |
| Dyspnoea‡ | 13% | <1% | 7% | 1% |
| Anaemia | 12% | 1% | 9% | 1% |
| Headache | 12% | <1% | 7% | 0 |
| Vomiting | 11% | 0 | 10% | 1% |
| URTI | 10% | 0 | 6% | 0 |
| Pyrexia | 10% | 0 | 4% | <1% |
| Prolonged QT interval ECG | 10% | 2% | 4% | <1% |
| AST elevation | 9% | <1% | 25% | 4% |
| Alopecia | 7% | 0 | 13% | 0 |
| ALT elevation | 6% | <1% | 27% | 9% |
Adapted from Soria JC et al. N Engl J Med 2018.1
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate transferase; ECG, electrocardiogram; URTI, upper respiratory tract infection
† This category represents a grouped term for the event. If a patient had multiple preferred-term events within a specific grouped-term adverse event, then the maximum grade (according to the Common Terminology Criteria for Adverse Events) across those events was counted.
‡ In the standard EGFR-TKI group, there were two patients who had missing data on grade, one with diarrhoea and one with nausea. In addition, there was one patient with grade 5 diarrhoea and one patient with grade 5 dyspnoea.
Take a closer look at how TAGRISSO is administered: FLAURA trial
Take a look at real patient case studies: FLAURA trial
Learn more about how TAGRISSO works
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate transferase; ECG, electrocardiogram; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutant; ILD, interstitial lung disease; LVEF, left ventricular ejection fraction; MOA, mode of action; NSCLC, non-small cell lung cancer; QTc, corrected QT interval; SJS, Stevens-Johnson syndrome; TEN, toxic epidermal necrolysis; URTI, upper respiratory tract infection
GB-71909 | DOP: December 2025
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AstraZeneca by visiting https://contactazmedical.astrazeneca.com/ or by calling 0800 783 0033.
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