0 and older, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse Drug ReactionsPrimary· 60 weeks
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XELJANZ in a participant who received XELJANZ. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XELJANZ was assessed by the physician.
ADR
Group
Value
95% CI
XELJANZ Tablets 5 mg (Tofacitinib Citrate)
466
Serious ADR
Group
Value
95% CI
XELJANZ Tablets 5 mg (Tofacitinib Citrate)
46
Adverse events — posted to ClinicalTrials.gov
Time frame: 60 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
XELJANZ Tablets 5 mg (Tofacitinib Citrate)
Serious: 103/1995 (5%)
Deaths: 1/1995
Serious adverse events (62 terms)
Reaction
System
XELJANZ Tablets 5 mg (Tofa…
Colitis ulcerative
Gastrointestinal disorders
—
Pyrexia
General disorders
—
Therapeutic response decreased
General disorders
—
Herpes zoster
Infections and infestations
—
Anaemia
Blood and lymphatic system disorders
—
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Retinal detachment
Eye disorders
—
Abdominal pain
Gastrointestinal disorders
—
Drug ineffective
General disorders
—
Atypical mycobacterial infection
Infections and infestations
—
Cytomegalovirus enterocolitis
Infections and infestations
—
Cytomegalovirus infection
Infections and infestations
—
Pneumonia
Infections and infestations
—
Pyelonephritis
Infections and infestations
—
Decreased appetite
Metabolism and nutrition disorders
—
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Testis cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Myelosuppression
Blood and lymphatic system disorders
—
Anal fistula
Gastrointestinal disorders
—
Melaena
Gastrointestinal disorders
—
Nausea
Gastrointestinal disorders
—
Oesophageal ulcer
Gastrointestinal disorders
—
Rectal perforation
Gastrointestinal disorders
—
Subileus
Gastrointestinal disorders
—
Vomiting
Gastrointestinal disorders
—
Other adverse events (217 terms — click to expand)
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 8 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03643211.