Trial Outcomes & Findings for Korean Post-marketing Surveillance for Xeljanz (NCT NCT02984020)
NCT ID: NCT02984020
Last Updated: 2024-08-27
Results Overview
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Xeljanz was assessed by the physician.
COMPLETED
1041 participants
From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
2024-08-27
Participant Flow
This was a study conducted in Korea. The investigator enrolled participants to whom Xeljanz was prescribed for the first time according to the local product document and who agreed to participate in this study. Xeljanz was administered according to the "Dosage and Administration" of the approved labeling. Xeljanz was medicated by the investigator's prescription under usual clinical practice.
Participant milestones
| Measure |
Post-Marketing Surveillance: Xeljanz
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Overall Study
STARTED
|
1041
|
|
Overall Study
COMPLETED
|
1009
|
|
Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
| Measure |
Post-Marketing Surveillance: Xeljanz
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Overall Study
Experienced off-label use against Xeljanz local product document
|
21
|
|
Overall Study
Not met the inclusion/exclusion criterion
|
9
|
|
Overall Study
Other significant protocol violation
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Post-Marketing Surveillance: Xeljanz
n=1009 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Age, Continuous
Mean
|
55.04 Years
STANDARD_DEVIATION 12.64 • n=1009 Participants
|
|
Age, Customized
< 40 years
|
126 Participants
n=1009 Participants
|
|
Age, Customized
>= 40 years and < 50 years
|
195 Participants
n=1009 Participants
|
|
Age, Customized
>= 50 years and < 60 years
|
305 Participants
n=1009 Participants
|
|
Age, Customized
>= 60 years and < 70 years
|
258 Participants
n=1009 Participants
|
|
Age, Customized
>= 70 years
|
125 Participants
n=1009 Participants
|
|
Sex: Female, Male
Female
|
852 Participants
n=1009 Participants
|
|
Sex: Female, Male
Male
|
157 Participants
n=1009 Participants
|
|
Indication, RA/PsA
RA
|
1009 Participants
n=1009 Participants
|
|
Indication, RA/PsA
PsA
|
0 Participants
n=1009 Participants
|
|
Duration of the disease, Continuous
|
98.36 Months
STANDARD_DEVIATION 80.77 • n=1009 Participants
|
|
Duration of the disease, Customized
< 3 years
|
219 Participants
n=1009 Participants
|
|
Duration of the disease, Customized
>= 3 years and < 6 years
|
193 Participants
n=1009 Participants
|
|
Duration of the disease, Customized
>= 6 years and < 9 years
|
146 Participants
n=1009 Participants
|
|
Duration of the disease, Customized
>= 9 years and < 12 years
|
121 Participants
n=1009 Participants
|
|
Duration of the disease, Customized
>= 12 years
|
214 Participants
n=1009 Participants
|
|
Duration of the disease, Customized
Unknown
|
116 Participants
n=1009 Participants
|
|
Severity of disease activity, High/Moderate/Low/Not assessed
High (DAS28 > 5.1)
|
874 Participants
n=1009 Participants
|
|
Severity of disease activity, High/Moderate/Low/Not assessed
Moderate (DAS28 > 3.2 and <= 5.1)
|
135 Participants
n=1009 Participants
|
|
Severity of disease activity, High/Moderate/Low/Not assessed
Low (DAS28 <= 3.2)
|
0 Participants
n=1009 Participants
|
|
Severity of disease activity, High/Moderate/Low/Not assessed
Not assessed
|
0 Participants
n=1009 Participants
|
|
Radiologic progression, Yes/No/Not assessed
Yes
|
506 Participants
n=1009 Participants
|
|
Radiologic progression, Yes/No/Not assessed
No
|
290 Participants
n=1009 Participants
|
|
Radiologic progression, Yes/No/Not assessed
Not assessed
|
213 Participants
n=1009 Participants
|
|
Status of latent tuberculosis, Yes/No/Unknown
Yes
|
226 Participants
n=1009 Participants
|
|
Status of latent tuberculosis, Yes/No/Unknown
No
|
770 Participants
n=1009 Participants
|
|
Status of latent tuberculosis, Yes/No/Unknown
Unknown
|
13 Participants
n=1009 Participants
|
|
Herpes zoster Vaccination, Yes/No/Unknown
Yes
|
115 Participants
n=1009 Participants
|
|
Herpes zoster Vaccination, Yes/No/Unknown
No
|
407 Participants
n=1009 Participants
|
|
Herpes zoster Vaccination, Yes/No/Unknown
Unknown
|
487 Participants
n=1009 Participants
|
|
Smoking, Ex-smoking/Current smoking/Non-smoking/Unknown
Ex-smoking
|
64 Participants
n=1009 Participants
|
|
Smoking, Ex-smoking/Current smoking/Non-smoking/Unknown
Current smoking
|
57 Participants
n=1009 Participants
|
|
Smoking, Ex-smoking/Current smoking/Non-smoking/Unknown
Non-smoking
|
706 Participants
n=1009 Participants
|
|
Smoking, Ex-smoking/Current smoking/Non-smoking/Unknown
Unknown
|
182 Participants
n=1009 Participants
|
|
Renal disorder, Yes/No
Yes
|
19 Participants
n=1009 Participants
|
|
Renal disorder, Yes/No
No
|
990 Participants
n=1009 Participants
|
|
Hepatic disorder, Yes/No
Yes
|
40 Participants
n=1009 Participants
|
|
Hepatic disorder, Yes/No
No
|
969 Participants
n=1009 Participants
|
|
Allergic history, Yes/No
Yes
|
25 Participants
n=1009 Participants
|
|
Allergic history, Yes/No
No
|
984 Participants
n=1009 Participants
|
|
Prior rheumatoid arthritis therapy, Yes/No
Yes
|
890 Participants
n=1009 Participants
|
|
Prior rheumatoid arthritis therapy, Yes/No
No
|
119 Participants
n=1009 Participants
|
|
Concomitant medication, Yes/No
Yes
|
997 Participants
n=1009 Participants
|
|
Concomitant medication, Yes/No
No
|
12 Participants
n=1009 Participants
|
PRIMARY outcome
Timeframe: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Xeljanz was assessed by the physician.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=1009 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
Adverse Events(AEs)
|
261 Participants
|
|
Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
Adverse Drug Reactions(ADRs)
|
148 Participants
|
|
Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
Serious Adverse Events(SAEs)
|
40 Participants
|
|
Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
Serious Adverse Drug Reactions(SADRs)
|
20 Participants
|
|
Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
Adverse Events of Special Interest
|
21 Participants
|
|
Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
Adverse Drug Reactions of Special Interest
|
16 Participants
|
PRIMARY outcome
Timeframe: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. SADR was any SAE that is attributed to Xeljanz. Relatedness to Xeljanz was assessed by the physician. An unexpected AE was an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug. Unexpected ADRs were unexpected AEs that were, in the investigator's opinion, of causal relationship to the study treatment.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=1009 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs
Unexpected Adverse Events
|
99 Participants
|
|
Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs
Unexpected Adverse Drug Reactions
|
31 Participants
|
|
Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs
Unexpected Serious Adverse Events
|
11 Participants
|
|
Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs
Unexpected Serious Adverse Drug Reactions
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Only participants with available data are reported.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=163 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Duration of Adverse Events
|
26 Days
Interval 0.0 to 320.0
|
PRIMARY outcome
Timeframe: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
The evaluation of AE severity was done according to the following categories: mild: not causing any significant problem to the participant. Administration of medicinal product continues without dose adjustment. Moderate: causes a problem that dose not interfere significantly with usual activities or the clinical status. Dose of the medical product is adjusted or other therapy is added due to the AE. Severe: causes a problem that interferes significantly with usual activities or the clinical status. The medicinal product is stopped due to the AE. Only participants with available severity assessment data are reported.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=261 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Participants With Adverse Events by Their Severity
Mild
|
201 Participants
|
|
Number of Participants With Adverse Events by Their Severity
Moderate
|
82 Participants
|
|
Number of Participants With Adverse Events by Their Severity
Severe
|
7 Participants
|
PRIMARY outcome
Timeframe: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The outcomes of AE included recovered, recovered with sequelae, recovering, not recovered and unknown. One participant may experience more than one event hence one participant may be included in more than one category specified below. Only participants with available outcome assessment are reported.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=261 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Participants With Adverse Events by Their Outcome
Recovered
|
200 Participants
|
|
Number of Participants With Adverse Events by Their Outcome
Recovered with sequelae
|
1 Participants
|
|
Number of Participants With Adverse Events by Their Outcome
Recovering
|
43 Participants
|
|
Number of Participants With Adverse Events by Their Outcome
Not recovered
|
38 Participants
|
|
Number of Participants With Adverse Events by Their Outcome
Unknown
|
7 Participants
|
PRIMARY outcome
Timeframe: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The seriousness criteria for AEs included results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect, other important medical event. Only participants with available seriousness assessment data are reported.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=261 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Participants With Adverse Events by Their Seriousness Criteria
Results in death
|
2 Participants
|
|
Number of Participants With Adverse Events by Their Seriousness Criteria
Is life-threatening
|
1 Participants
|
|
Number of Participants With Adverse Events by Their Seriousness Criteria
Requires inpatient hospitalization or prolongation of hospitalization
|
40 Participants
|
|
Number of Participants With Adverse Events by Their Seriousness Criteria
Results in persistent or significant disability/incapacity
|
0 Participants
|
|
Number of Participants With Adverse Events by Their Seriousness Criteria
Results in congenital anomaly/birth defect
|
0 Participants
|
|
Number of Participants With Adverse Events by Their Seriousness Criteria
Is an important medical event
|
0 Participants
|
|
Number of Participants With Adverse Events by Their Seriousness Criteria
Non-SAE
|
238 Participants
|
PRIMARY outcome
Timeframe: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The action taken with regard to the medicinal product included: permanently discontinued, temporarily discontinued or delayed, dose reduced, dose increased, no change, not applicable. Only participants with available action taken assessment data are reported.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=261 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz
Permanently discontinued
|
45 Participants
|
|
Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz
Temporarily discontinued or delayed
|
35 Participants
|
|
Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz
Dose reduced
|
14 Participants
|
|
Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz
No change
|
188 Participants
|
|
Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz
Not applicable
|
4 Participants
|
PRIMARY outcome
Timeframe: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The causality of AEs to Xeljanz were assessed by physician according to the following criteria: certain, probable/likely, possible, unlikely, conditional/unclassified and unassessible/unclassifiable. One participant may experience more than one event hence, one participant may be included in more than one category specified below. Only participants with available causality assessment data are reported.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=261 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Participants With Adverse Events by Their Causality to Xeljanz
Certain
|
1 Participants
|
|
Number of Participants With Adverse Events by Their Causality to Xeljanz
Probable/likely
|
9 Participants
|
|
Number of Participants With Adverse Events by Their Causality to Xeljanz
Possible
|
101 Participants
|
|
Number of Participants With Adverse Events by Their Causality to Xeljanz
Unlikely
|
134 Participants
|
|
Number of Participants With Adverse Events by Their Causality to Xeljanz
Conditional/unclassified
|
17 Participants
|
|
Number of Participants With Adverse Events by Their Causality to Xeljanz
Unaccessible/unclassifiable
|
25 Participants
|
PRIMARY outcome
Timeframe: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Number of participants with AEs classified according to the following demographic characteristics: sex: male and female; age: less than (\<) 40 years, greater than or equal to (\>=) 40 and \< 50 years and \>= 50 years and \<60 years; \>= 60 and \<70 years; geriatric (\>=65 years). Only participants with available demographic and AE assessment data are reported.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=261 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Participants With Adverse Events According to Demographic Characteristics
Sex: Male
|
36 Participants
|
|
Number of Participants With Adverse Events According to Demographic Characteristics
Sex: Female
|
225 Participants
|
|
Number of Participants With Adverse Events According to Demographic Characteristics
Age: < 40 years
|
35 Participants
|
|
Number of Participants With Adverse Events According to Demographic Characteristics
Age: >= 40 years and < 50 years
|
48 Participants
|
|
Number of Participants With Adverse Events According to Demographic Characteristics
Age: >= 50 years and < 60 years
|
79 Participants
|
|
Number of Participants With Adverse Events According to Demographic Characteristics
Age: >= 60 years and < 70 years
|
63 Participants
|
|
Number of Participants With Adverse Events According to Demographic Characteristics
Age: >= 70 years
|
36 Participants
|
|
Number of Participants With Adverse Events According to Demographic Characteristics
Geriatric (>= 65 years)
|
67 Participants
|
PRIMARY outcome
Timeframe: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
Other baseline characteristics included: indication; duration of the disease; severity of disease; radiologic progression; status of latent tuberculosis; herpes zoster vaccination; smoking; prior rheumatoid arthritis therapy; medical history; renal disorder; hepatic disorder; allergic history; concomitant medication; duration of administration. Only participants with available other baseline characteristics and AE assessment data are reported.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=261 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Indication: RA
|
261 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Indication: PsA
|
0 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Duration of the disease: < 3 years
|
55 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Duration of the disease: >= 3 years and < 6 years
|
47 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Duration of the disease: >= 6 years and < 9 years
|
25 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Duration of the disease: >= 9 years and < 12 years
|
35 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Duration of the disease: >= 12 years
|
70 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Duration of the disease: Unknown
|
29 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Severity of disease activity: High (DAS28 > 5.1)
|
226 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Severity of disease activity: Moderate (DAS28 > 3.2 and <= 5.1)
|
35 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Severity of disease activity: Low (DAS28 <= 3.2)
|
0 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Severity of disease activity: Not assessed
|
0 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Radiologic progression: Yes
|
132 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Radiologic progression: No
|
62 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Radiologic progression: Not assessed
|
67 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Status of latent tuberculosis: Yes
|
52 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Status of latent tuberculosis: No
|
206 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Status of latent tuberculosis: Unknown
|
3 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Herpes zoster Vaccination: Yes
|
33 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Herpes zoster Vaccination: No
|
125 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Herpes zoster Vaccination: Unknown
|
103 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Smoking: Ex-smoking
|
18 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Smoking: Current smoking
|
16 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Smoking: Non-smoking
|
188 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Smoking: Unknown
|
39 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Prior rheumatoid arthritis therapy: Yes
|
238 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Prior rheumatoid arthritis therapy: No
|
23 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Medical history: Yes
|
209 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Medical history: No
|
52 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Renal disorder: Yes
|
6 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Renal disorder: No
|
255 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Hepatic disorder: Yes
|
13 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Hepatic disorder: No
|
248 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Allergic history: Yes
|
11 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Allergic history: No
|
250 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Concomitant medication: Yes
|
259 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Concomitant medication: No
|
2 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Duration of administration: < 6 months
|
75 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Duration of administration: >= 6 months and < 7 months
|
135 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Duration of administration: >= 7 months
|
39 Participants
|
|
Number of Participants With Adverse Events According to Other Baseline Characteristics
Duration of administration: Unknown
|
12 Participants
|
PRIMARY outcome
Timeframe: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Logistic regression analysis of multivariate analysis was performed and presented an odds ratio with 95% confidence interval to identify the factors that affect occurrence of AEs in demography and baseline characteristics, or concomitant treatment status, etc.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=1009 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis
|
261 Participants
|
PRIMARY outcome
Timeframe: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)Population: The population included geriatric participants (aged \>=65 years) in the safety population.
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=238 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Geriatric Participants With Adverse Events and Adverse Drug Reactions
Adverse Events
|
67 Participants
|
|
Number of Geriatric Participants With Adverse Events and Adverse Drug Reactions
Adverse Drug Reactions
|
43 Participants
|
PRIMARY outcome
Timeframe: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)Population: The population included participants with renal disorder in the safety population.
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. Renal disorder was judged by the investigator.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=19 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Participants With Adverse Events and Adverse Drug Reactions - Renal Disorder
Adverse Events
|
6 Participants
|
|
Number of Participants With Adverse Events and Adverse Drug Reactions - Renal Disorder
Adverse Drug Reactions
|
5 Participants
|
PRIMARY outcome
Timeframe: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)Population: The population included participants with hepatic disorder in the safety population.
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. Hepatic disorder was judged by the investigator.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=40 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Participants With Adverse Events and Adverse Drug Reactions - Hepatic Disorder
Adverse Events
|
13 Participants
|
|
Number of Participants With Adverse Events and Adverse Drug Reactions - Hepatic Disorder
Adverse Drug Reactions
|
7 Participants
|
PRIMARY outcome
Timeframe: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)Population: The population included participants excluded from the safety population.
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. AEs and ADRs for participants excluded from the safety analysis population were reported. The reason for exclusion included: not met the inclusion criteria/met exclusion criteria; off-label use; other significant protocol violation.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=31 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Participants With Adverse Events and Adverse Drug Reactions - Other Than Safety Analysis Population
Adverse Events
|
14 Participants
|
|
Number of Participants With Adverse Events and Adverse Drug Reactions - Other Than Safety Analysis Population
Adverse Drug Reactions
|
9 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)Population: The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment.
DAS28 is a modified version of the original Disease Activity Score (DAS). It is a quantitative measure of disease activity used to monitor the treatment or RA. DAS28 (erythrocyte sedimentation rate \[ESR\]) was calculated from: DAS28 (ESR) = 0.56\*√(tender joint counter \[TJC\] 28) + 0.28\*√(swollen joint count \[SJC\] 28) + 0.014\*VAS+ 0.70\*ln(ESR), where VAS = visual analogue scale. Total score range: 0-9.4, higher score=more disease activity.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=841 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Change From Baseline in DAS28 (ESR)
|
-2.35 Scores on a scale
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)Population: The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment.
DAS28 is a modified version of the original Disease Activity Score (DAS). It is a quantitative measure of disease activity used to monitor the treatment or RA. DAS28-3 ( C-reactive protein \[CRP\]) was calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=455 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Change From Baseline in DAS28 (CRP)
|
-2.42 Scores on a scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)Population: The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment.
European League Against Rheumatism (EULAR) response is a DAS-based response criteria that classifies individual participants as none, moderate, or good responders, depending on the extent of change and the level of disease activity reached. Participants with improvement in DAS28 from baseline \>1.2 and DAS28 based EULAR \<=3.2 were good responders; participants with improvement in DAS28 from baseline \>0.6 and \<=1.2 and DAS28 based EULAR \>3.2 and \<=5.1 were moderate responders; participants with improvement in DAS28 from baseline \<=0.6 and DAS28-based EULAR \>5.1 were none responders.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=903 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Participants With EULAR Response
Good
|
404 Participants
|
|
Number of Participants With EULAR Response
Moderate
|
446 Participants
|
|
Number of Participants With EULAR Response
None
|
53 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)Population: The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment.
ACR20 response: ≥20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and CRP.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=903 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Month 6
|
209 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)Population: The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment.
The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment. No change and aggravated were classified as ineffective.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=903 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Participants With Effectiveness
Effective: Improved
|
853 Participants
|
|
Number of Participants With Effectiveness
Ineffective: No change
|
36 Participants
|
|
Number of Participants With Effectiveness
Ineffective: Aggravated
|
14 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)Population: The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment and with improved effectiveness.
The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=853 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Participants With Effectiveness by Demographic Characteristics
Sex: Male
|
128 Participants
|
|
Number of Participants With Effectiveness by Demographic Characteristics
Sex: Female
|
725 Participants
|
|
Number of Participants With Effectiveness by Demographic Characteristics
Age: < 40 years
|
110 Participants
|
|
Number of Participants With Effectiveness by Demographic Characteristics
Age: >= 40 years and < 50 years
|
162 Participants
|
|
Number of Participants With Effectiveness by Demographic Characteristics
Age: >= 50 years and < 60 years
|
256 Participants
|
|
Number of Participants With Effectiveness by Demographic Characteristics
Age: >= 60 years and < 70 years
|
219 Participants
|
|
Number of Participants With Effectiveness by Demographic Characteristics
Age: >= 70 years
|
106 Participants
|
|
Number of Participants With Effectiveness by Demographic Characteristics
Geriatric (>= 65 years)
|
200 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)Population: The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment and with improved effectiveness.
The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment. Logistic regression analysis of multivariate analysis was performed and presented as odds ratios with 95% confidence interval to identify the factors that affected classified overall assessment (effective/ineffective) in demography and baseline characteristics of the participants.
Outcome measures
| Measure |
Post-Marketing Surveillance: Xeljanz
n=903 Participants
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Number of Participants With Improved Effectiveness - Multivariate Logistic Regression Analysis
|
853 Participants
|
Adverse Events
Post-Marketing Surveillance: Xeljanz
Serious adverse events
| Measure |
Post-Marketing Surveillance: Xeljanz
n=1009 participants at risk
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Constipation
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Appendicitis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Arthritis bacterial
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Cellulitis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Herpes zoster
|
0.50%
5/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Influenza
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Peritonsillar abscess
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Pneumonia
|
0.59%
6/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Pyelonephritis acute
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Sinusitis fungal
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Tooth abscess
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Nervous system disorders
Cerebral infarction
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Nervous system disorders
Mononeuritis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Vascular disorders
Deep vein thrombosis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
Other adverse events
| Measure |
Post-Marketing Surveillance: Xeljanz
n=1009 participants at risk
Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Cardiac disorders
Tachycardia
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Congenital, familial and genetic disorders
Type IIa hyperlipidaemia
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Ear and labyrinth disorders
Deafness
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Eye disorders
Cataract
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Eye disorders
Diplopia
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Eye disorders
Dry eye
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Eye disorders
Eye pain
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Eye disorders
Vision blurred
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.30%
3/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.40%
4/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.50%
5/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Constipation
|
0.59%
6/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.79%
8/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Dry mouth
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.69%
7/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Enteritis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Nausea
|
0.89%
9/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Stomatitis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
General disorders
Asthenia
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
General disorders
Chest discomfort
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
General disorders
Chest pain
|
0.30%
3/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
General disorders
Chills
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
General disorders
Face oedema
|
0.79%
8/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
General disorders
Fatigue
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
General disorders
Generalised oedema
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
General disorders
Oedema peripheral
|
0.69%
7/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
General disorders
Swelling face
|
0.30%
3/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Hepatobiliary disorders
Liver disorder
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Abscess limb
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Bacteraemia
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Bronchitis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Cellulitis
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Cystitis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Folliculitis
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Gastroenteritis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Gingivitis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Herpes simplex
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Herpes zoster
|
2.3%
23/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Influenza
|
0.30%
3/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
31/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Oral herpes
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Periodontitis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Pneumonia
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Pyelonephritis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Rhinitis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Sinusitis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Skin infection
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Tinea cruris
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Tinea versicolour
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Tuberculosis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.89%
9/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Urinary tract infection
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Infections and infestations
Vaginal infection
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Investigations
Alanine aminotransferase abnormal
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Investigations
Alanine aminotransferase increased
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Investigations
Aspartate aminotransferase abnormal
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Investigations
Aspartate aminotransferase increased
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Investigations
Blood cholesterol increased
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Investigations
Blood pressure increased
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Investigations
Hepatic enzyme increased
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Investigations
High density lipoprotein increased
|
0.50%
5/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Investigations
Liver function test abnormal
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Investigations
Liver function test increased
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Investigations
Weight decreased
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Investigations
Weight increased
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.50%
5/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.50%
5/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.40%
4/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.40%
4/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid nodule
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Nervous system disorders
Cognitive disorder
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Nervous system disorders
Dizziness
|
1.3%
13/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Nervous system disorders
Headache
|
0.59%
6/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Nervous system disorders
Hypoaesthesia
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Nervous system disorders
Memory impairment
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Nervous system disorders
Migraine
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Nervous system disorders
Paraesthesia
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Nervous system disorders
Tension headache
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Psychiatric disorders
Insomnia
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Renal and urinary disorders
Dysuria
|
0.30%
3/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Renal and urinary disorders
Renal cyst
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Reproductive system and breast disorders
Breast mass
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Reproductive system and breast disorders
Breast pain
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.59%
6/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.30%
3/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord thickening
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.50%
5/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.30%
3/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.20%
2/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.69%
7/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Vascular disorders
Hypertension
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
|
Vascular disorders
Thrombosis
|
0.10%
1/1009 • From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclosure previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER