Safety through Week 56
| Event | UPA 15 mg QD (n=290; PY=419.4) | UPA 30 mg QD (n=308; PY=423.5) |
| EAER, events/100 PY (95% CI) | ||
| Infection | 89.7 (81.0–99.2) | 113.6 (103.9–124.2) |
| Serious infection | 2.6 (1.5–4.7) | 6.1 (4.2–9.0) |
| Opportunistic infectiona | 0.7 (0.2–2.2) | 0.9 (0.4–2.5) |
| HZ | 3.8 (2.3–6.2) | 8.5 (6.1–11.8) |
| Active TB | 0 | 0 |
| Gastrointestinal perforation (adjudicated) | 0 | 0 |
| Hepatic disorder | 4.8 (3.1–7.4) | 17.7 (14.1–22.2) |
| Anemia | 2.1 (1.1–4.1) | 5.4 (3.6–8.2) |
| Neutropenia | 1.0 (0.4–2.5) | 3.1 (1.8–5.3) |
| Lymphopenia | 0.7 (0.2–2.2) | 2.4 (1.3–4.4) |
| CPK elevation | 5.2 (3.5–8.0) | 8.7 (6.3–12.1) |
| Renal dysfunction | 0.5 (0.1–1.9) | 0.2 (0.0–1.7) |
| EAIR, n/100 PY (95% CI) | ||
| NMSCb | 1.2 (0.5–2.9) | 1.0 (0.4–2.5) |
| Malignancy other than NMSCc | 1.2 (0.5–2.9) | 1.2 (0.5–2.9) |
| Lymphomad | 0.5 (0.1–1.9) | 0 |
| MACE (adjudicated) | 0.2 (0–1.7) | 0.2 (0–1.7) |
| VTE (adjudicated) | 0.2 (0–1.7) | 0.2 (0–1.7) |
aExcludes TB and HZ. bUPA 15 mg: 4 cases of BCC and 1 case of SCC of the skin; UPA 30 mg: 3 cases of BCC and 3 cases of SCC of the skin. cUPA 15 mg: 2 cases of prostate cancer, and single cases of malignant melanoma, ovarian cancer, and rectal cancer; UPA 30 mg: single cases of basosquamous carcinoma (considered NMSC after medical review), malignant melanoma, oropharyngeal SCC, and rectal adenocarcinoma, as well as endometrial cancer and ovarian cancer (in the same patient). dUPA 15 mg: 2 events of treatment-emergent abnormal lymphocyte morphology; abnormal lymphocytes were not reported in subsequent laboratory testing
BCC, basal cell carcinoma; CI, confidence interval; NMSC, non-melanoma skin cancer; PY, patient-years; SCC, squamous cell carcinoma; TB, tuberculosis