Incidence of AEs during the DFT and OLE trial with leniolisib
| AE∗,† . | nS (%) . |
|---|---|
| Acute sinusitis | 1 (17) |
| Allergic rhinitis | 1 (17) |
| ALP increase | 1 (17) |
| ALT increase | 1 (17) |
| Anxiety | 1 (17) |
| Cellulitis | 1 (17) |
| Chest pain | 1 (17) |
| Common cold | 1 (17) |
| Cold sore | 1 (17) |
| Cough | 2 (33) |
| COVID-19 dyspnea | 1 (17) |
| COVID-19 negative | 3 (50) |
| COVID-19 positive | 2 (33) |
| Dental caries | 1 (17) |
| Diarrhea | 2 (33) |
| Folliculitis | 1 (17) |
| Fuchs heterochromic cyclitis | 1 (17) |
| Fungal infection | 1 (17) |
| Gastroenteritis | 2 (33) |
| Gastroparesis | 1 (17) |
| GGT increase | 1 (17) |
| Gut infection | 1 (17) |
| Hair loss | 1 (17) |
| Hearing loss | 1 (17) |
| Hepatopathy | 1 (17) |
| Hypercholesterolemia | 1 (17) |
| Hypertriglyceridemia | 1 (17) |
| Influenza | 1 (17) |
| Joint pain | 1 (17) |
| Lyme disease | 1 (17) |
| Myalgia | 1 (17) |
| Neutropenia | 1 (17) |
| Oral ulcer | 1 (17) |
| Otitis externa | 2 (33) |
| Otitis media | 3 (50) |
| Paresthesia | 1 (17) |
| Petechiae | 1 (17) |
| Pruritus | 1 (17) |
| Rash | 1 (17) |
| Reactive arthritis | 1 (17) |
| Reflex esophagitis | 1 (17) |
| Seborrheic dermatitis | 2 (33) |
| Skin infection | 1 (17) |
| Sore throat | 2 (33) |
| Stomach ache | 1 (17) |
| Sunburn | 1 (17) |
| Upper respiratory infection | 3 (50) |
| Weight gain | 1 (17) |
| Xerostomia | 1 (17) |
| AE∗,† . | nS (%) . |
|---|---|
| Acute sinusitis | 1 (17) |
| Allergic rhinitis | 1 (17) |
| ALP increase | 1 (17) |
| ALT increase | 1 (17) |
| Anxiety | 1 (17) |
| Cellulitis | 1 (17) |
| Chest pain | 1 (17) |
| Common cold | 1 (17) |
| Cold sore | 1 (17) |
| Cough | 2 (33) |
| COVID-19 dyspnea | 1 (17) |
| COVID-19 negative | 3 (50) |
| COVID-19 positive | 2 (33) |
| Dental caries | 1 (17) |
| Diarrhea | 2 (33) |
| Folliculitis | 1 (17) |
| Fuchs heterochromic cyclitis | 1 (17) |
| Fungal infection | 1 (17) |
| Gastroenteritis | 2 (33) |
| Gastroparesis | 1 (17) |
| GGT increase | 1 (17) |
| Gut infection | 1 (17) |
| Hair loss | 1 (17) |
| Hearing loss | 1 (17) |
| Hepatopathy | 1 (17) |
| Hypercholesterolemia | 1 (17) |
| Hypertriglyceridemia | 1 (17) |
| Influenza | 1 (17) |
| Joint pain | 1 (17) |
| Lyme disease | 1 (17) |
| Myalgia | 1 (17) |
| Neutropenia | 1 (17) |
| Oral ulcer | 1 (17) |
| Otitis externa | 2 (33) |
| Otitis media | 3 (50) |
| Paresthesia | 1 (17) |
| Petechiae | 1 (17) |
| Pruritus | 1 (17) |
| Rash | 1 (17) |
| Reactive arthritis | 1 (17) |
| Reflex esophagitis | 1 (17) |
| Seborrheic dermatitis | 2 (33) |
| Skin infection | 1 (17) |
| Sore throat | 2 (33) |
| Stomach ache | 1 (17) |
| Sunburn | 1 (17) |
| Upper respiratory infection | 3 (50) |
| Weight gain | 1 (17) |
| Xerostomia | 1 (17) |
ALP, alkaline phosphatase; ALT, alanine transaminase; GGT, γ-glutamyl transferase; nS, number of patients with at least 1 AE in the category.
A patient with multiple occurrences of an AE is counted only once in the AE category. Only AEs occurring at, or after, first drug intake are included.
AEs were captured from OLE AEs files. AEs were reported through clinical assessments, nondirective interviewing of each patient, or as volunteered by the patient. Detected AEs were followed-up until resolution.