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Table 3 Incidence of adverse events in different arms in the BOLERO-2 and SOLAR-1 trials

From: Everolimus versus alpelisib in advanced hormone receptor-positive HER2-negative breast cancer: targeting different nodes of the PI3K/AKT/mTORC1 pathway with different clinical implications

Adverse eventEverolimus and exemestane group (N = 482)Placebo and exemestane group (N = 238)Alpelisib and fulvestrant group (N = 284)Placebo and fulvestrant group (N = 287)
Any gradeGrade 3Grade 4Any gradeGrade 3Grade 4Any gradeGrade 3Grade 4Any gradeGrade 3Grade 4
Hyperglicemia166< 131063.732.73.99.80.30.3
Stomatitis678012< 1024.62.506.300
Rash361060035.69.905.90.30
Fatigue374< 1271024.33.5017.11.00
Diarrhea302< 1161057.76.7015.70.30
Nausea27< 1< 1271044.72.5022.30.30
Decreased appetite2910100035.60.7010.50.30
Vomiting14< 1< 111< 1027.10.709.80.30
Weight loss191050026.83.902.100
Dysgeusia21< 1050016.5003.500
Headache19< 10130017.60.7013.200
Asthenia122030020.41.8012.900
Pruritus11< 10300180.705.600
Arthralgia1610160011.30.4016.41.00
Cough22101100//////
Dyspnea184091< 1//////
Pneumonitis1230000//////
Anemia16514< 1< 1//////
Thrombocytopenia1221< 10< 1//////
Epistaxis1500100//////
Pyrexia14< 106< 10//////
Peripheral edema14106< 10//////
AST level increaseda133< 1610//////
ALT level increasedb113< 1320//////
Constipation13< 1011< 10//////
Insomnia11< 10800//////
Back pain1100810//////
Hyperlipidemia1410200//////
Infections and infestations50522520//////
Alopecia//////19.7002.400
Mucosal inflammation//////18.32.101.000
  1. “/,” adverse event not evaluated in this trial
  2. aAspartate aminotransferase
  3. bAlanine aminotransferase