. Author manuscript; available in PMC: 2022 Aug 1.

Published in final edited form as: Clin Gastroenterol Hepatol. 2020 Jul 3;19(8):1592–1601.e3. doi: 10.1016/j.cgh.2020.06.050

Table 3:

Characteristics of Serious Adverse Events

Number with Serious AE, n (% of cohort)	15 (5.8)
SAEs requiring hospitalization, n
Infections	2
Septic arthritis^a	1
Group B Strep bacteremia	1
Malignancy - Cervical rhabdomyosarcoma^b	1
SAEs leading to discontinuation of tofacitinib, n
Rash (Herpes Zoster reactivation)	4
Anemia	2
Migraine headache	1
Cough, headache, chest pain, lightheadedness	1
Urinary frequency and incontinence	1
Muscle cramps	1
Fever	1
Malignancy – Cervical rhabdomyosarcoma^b	1
Venous Thrombo-embolic events: DVT^a	2
Induction dosing, no (%)
5mg bid or 11mg XR daily	2 (13.3)
10mg bid	13 (86.7)
Maintenance dosing prior to discontinuation, no (%)
5mg bid or 11mg XR daily	2 (13.3)
10mg bid	13 (86.7)
Incidence rate of SAEs, per 100 Patients-Year [95%CI]	10.0 (8.9 – 11.2)

AEs: Adverse Events;

^a,

One patient had a venous thrombo-embolic event (DVT) and septic arthritis;

^b,

One patient with cervical rhabdomyosarcoma was hospitalized for the SAE and discontinued tofacitinib; SAEs: Serious Adverse Events; DVT: Deep venous thrombosis.