Changes in lymphoproliferation parameters. (A) Individual untransformed SPD of index lymph nodes (leniolisib, n = 19; placebo, n = 9). Reference range (≤1.5 × 1.5 cm) not shown as up to 6 lymph nodes may be counted per patient.²⁶ (B) Individual spleen volumes (leniolisib, n = 20; placebo, n = 9). The gray box indicates the reference range for adults.²⁸ All patients from the safety analysis set with measurements are included in (A) and (B), whereas efficacy analyses used the PD analysis set. (C-J) Radiographic renderings of spleen volume (C, D, G, H) and lymph node diameters (E, F, I, J) at screening and D85 from 2 patients in the leniolisib arm. The images in the top row (C-F) are from a 29-year-old female. The investigator diagnosed splenomegaly at screen (C) that was deemed absent by D85 (D). The index axillary lymph node lesion outlined in red decreased in size over the trial (E-F). Yellow and purple outlines in (F) indicate non-index lymph nodes. The images in the bottom row (G-J) are from a 17-year-old male. The investigator diagnosed splenomegaly at screen (G) that remained present by D85 despite the spleen decreasing in size (H). The index upper cervical lymph node lesion outlined in red (I-J) decreased in size over the trial.