Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus

Number of Participants With Treatment-Emergent Adverse Events and Treatment Emergent Serious Adverse Events

A Treatment-Emergent Adverse Event (TEAE) is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes.

Time frame: From Day 1 until 30 days after last dose (up to approximately 42 months)

Number of Participants With Abnormalities in Vital Signs

Vital signs heart rate (HR) (beats/min), systolic blood pressure (SBP) (mmHG), and diastolic blood pressure (DBP) (mmHg).

Time frame: From Day 1 until 30 days after last dose (up to approximately 42 months)

Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities

Blood samples were collected to assess laboratory parameters. Grade 3 = Severe laboratory abnormality Grade 4 = Life-threatening or very severe laboratory abnormality

Time frame: From Day 1 until 30 days after last dose (up to approximately 42 months)