Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1)

Exclusion Criteria

• •For participants in the retrospective period
• •\- All EPIK-P1 participants who permanently discontinued the investigational drug on or prior to the cut-off date 09-Mar-2020.
• •For participants in the prospective period
• •Previous alpelisib treatment discontinuation (after 09-Mar-2020) due to any of the following adverse events:
• •* Grade 4 skin and subcutaneous tissue disorders
• •* Stevens-Johnson-Syndrome (SJS)/ Toxic Epidermal Necrolysis (TEN) or other SJS/TEN-like severe skin reactions (any grade)
• •* Grade 4 hyperglycemia without confounding factors
• •* Pneumonitis (any grade)
• •* Grade 4 stomatitis
• •* Grade 4 pancreatitis
• •* Recurrent grade 4 thrombocytopenia
• •* Grade 3 or 4 serum creatinine increase
• •* Grade 4 isolated total bilirubin elevation
• •* Recurrent grade 3 or 4 QT interval corrected by Fridericia's formula prolongation (\>500 ms or \>60 ms change from baseline)
• •Known impairment of GI function due to concomitant disease that may significantly alter the absorption of the study drug (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) at time of informed consent.
• •Participant with uncontrolled diabetes mellitus (Type I or II) at time of informed consent.