Trial Outcomes & Findings for Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis (NCT NCT01932372)

NCT ID: NCT01932372

Last Updated: 2024-10-26

Results Overview

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XELJANZ in a participant who received XELJANZ. A serious adverse event/adverse drug reaction (SADR) was a treatment-related adverse event 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.

Recruitment status

COMPLETED

Target enrollment

9968 participants

Primary outcome timeframe

36 months

Results posted on

2024-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	XELJANZ (Safety Analysis Set) Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion. Participants who did not meet the eligibility criteria and/or were not assessable for safety were excluded.	Control (MTX Adherent Comparative Safety Analysis Set) Participants with no experience of treatment with XELJANZ Tablets 5 mg, and received treatment other than XELJANZ Tablets 5 mg for rheumatoid arthritis (RA) were observed for a scheduled period of 36 months. The dosage can be adjusted as per physician's discretion. Participants who did not meet the eligibility criteria and/or were not assessable for safety were excluded.
Overall Study STARTED	7054	2598
Overall Study XELJANZ (Safety Analysis Set)	7021	2419
Overall Study XELJANZ (MTX Adherent Safety Analysis Set)	4574	0
Overall Study XELJANZ (MTX Adherent Comparative Safety Analysis Set)	3731	0
Overall Study COMPLETED	7021	2419
Overall Study NOT COMPLETED	33	179

Reasons for withdrawal

Reasons for withdrawal
Measure	XELJANZ (Safety Analysis Set) Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion. Participants who did not meet the eligibility criteria and/or were not assessable for safety were excluded.	Control (MTX Adherent Comparative Safety Analysis Set) Participants with no experience of treatment with XELJANZ Tablets 5 mg, and received treatment other than XELJANZ Tablets 5 mg for rheumatoid arthritis (RA) were observed for a scheduled period of 36 months. The dosage can be adjusted as per physician's discretion. Participants who did not meet the eligibility criteria and/or were not assessable for safety were excluded.
Overall Study Not meeting eligibility criteria	33	179

Baseline Characteristics

In the XELJANZ group, safety analysis set corresponds to overall. The MTX adherent safety analysis set is a group of participants who meet the eligibility criteria for MTX among the safety analysis set. The MTX adherent comparative safety analysis set is a group of participants in the safety analysis set who were observed for a scheduled period of 36 months and meet the eligibility criteria for MTX. In the Control group, the MTX adherent comparative safety analysis set corresponds to overall.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 36 months

Population: The MTX adherent safety analysis set (n=4574) comprised of participants who received XELJANZ Tablets 5 mg at least once for the treatment of poorly controlled RA despite continuous use of MTX, excluding participants who did not meet the conditions to receive MTX, participated in a clinical trial, or transferred to another hospital.

Outcome measures

Outcome measures
Measure	XELJANZ (MTX Adherent Safety Analysis Set) n=4574 Participants Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion. The MTX adherent safety analysis set was defined as the participants within the safety analysis set who have been poorly controlled even though MTX was used continuously at a dose of more than 8 mg/week for 3 months or longer.	Control (MTX Adherent Comparative Safety Analysis Set) Participants with no experience of treatment with XELJANZ Tablets 5 mg, and received treatment other than XELJANZ Tablets 5 mg for RA were observed for a scheduled period of 36 months. The dosage can be adjusted as per physician's discretion. Participants who did not meet the eligibility criteria and/or were not assessable for safety were excluded.	XELJANZ (MTX Adherent Efficacy Analysis Set) At 12 Months From Baseline Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion.	XELJANZ (MTX Adherent Efficacy Analysis Set) At 24 Months From Baseline Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion.	XELJANZ (MTX Adherent Efficacy Analysis Set) At 36 Months From Baseline Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion.
Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZ ADR	41.60 Percentage of Participants	—	—	—	—
Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZ Serious ADR	12.88 Percentage of Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, 1, 6, 12, 24, 36 months

Population: The MTX adherent efficacy analysis set (n=4455) comprised of participants who received XELJANZ Tablets 5 mg at least once for the treatment of poorly controlled RA despite continuous use of MTX, excluding participants who were confirmed ineligible or not assessable for effectiveness. Of the 4455 MTX adherent efficacy analysis set, the participants with available results at each evaluation point are described.

The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 cm VAS, and C-reactive protein (CRP) (mg/dL). SDAI is defined as follows: ≤3.3, disease remission; \>3.3 to ≤11, low disease activity, \>11 to ≤26, moderate disease activity; and \>26, high disease activity. SDAI was assessed at each evaluation time point and mean change from the start of XELJANZ was calculated with the 95% CI.

Outcome measures

Outcome measures
Measure	XELJANZ (MTX Adherent Safety Analysis Set) n=1937 Participants Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion. The MTX adherent safety analysis set was defined as the participants within the safety analysis set who have been poorly controlled even though MTX was used continuously at a dose of more than 8 mg/week for 3 months or longer.	Control (MTX Adherent Comparative Safety Analysis Set) n=2520 Participants Participants with no experience of treatment with XELJANZ Tablets 5 mg, and received treatment other than XELJANZ Tablets 5 mg for RA were observed for a scheduled period of 36 months. The dosage can be adjusted as per physician's discretion. Participants who did not meet the eligibility criteria and/or were not assessable for safety were excluded.	XELJANZ (MTX Adherent Efficacy Analysis Set) At 12 Months From Baseline n=1661 Participants Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion.	XELJANZ (MTX Adherent Efficacy Analysis Set) At 24 Months From Baseline n=1227 Participants Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion.	XELJANZ (MTX Adherent Efficacy Analysis Set) At 36 Months From Baseline n=976 Participants Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion.
Change in Disease Activity Based on Simplified Disease Activity Index (SDAI)	-10.16 Scores on a scale Interval -10.69 to -9.62	-14.59 Scores on a scale Interval -15.1 to -14.07	-15.97 Scores on a scale Interval -16.62 to -15.32	-16.88 Scores on a scale Interval -17.64 to -16.12	-17.37 Scores on a scale Interval -18.21 to -16.53

PRIMARY outcome

Timeframe: Baseline, 1, 6, 12, 24, 36 months

DAS28 is the numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, PtGA assessed on 0-10 cm VAS, and the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]). DAS28 is defined as follows: \<2.6, disease remission; ≥2.6 to \<3.2, low disease activity, ≥3.2 to ≤5.1, moderate disease activity; and \>5.1, high disease activity. DAS28 was assessed at each evaluation time point and mean change from the start of XELJANZ was calculated with the 95% CI.

Outcome measures

Outcome measures
Measure	XELJANZ (MTX Adherent Safety Analysis Set) n=1682 Participants Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion. The MTX adherent safety analysis set was defined as the participants within the safety analysis set who have been poorly controlled even though MTX was used continuously at a dose of more than 8 mg/week for 3 months or longer.	Control (MTX Adherent Comparative Safety Analysis Set) n=2119 Participants Participants with no experience of treatment with XELJANZ Tablets 5 mg, and received treatment other than XELJANZ Tablets 5 mg for RA were observed for a scheduled period of 36 months. The dosage can be adjusted as per physician's discretion. Participants who did not meet the eligibility criteria and/or were not assessable for safety were excluded.	XELJANZ (MTX Adherent Efficacy Analysis Set) At 12 Months From Baseline n=1440 Participants Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion.	XELJANZ (MTX Adherent Efficacy Analysis Set) At 24 Months From Baseline n=1074 Participants Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion.	XELJANZ (MTX Adherent Efficacy Analysis Set) At 36 Months From Baseline n=852 Participants Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion.
Change in Disease Activity Score Based on 28-joints Count (DAS28)	-0.98 Scores on a scale Interval -1.04 to -0.92	-1.52 Scores on a scale Interval -1.58 to -1.46	-1.67 Scores on a scale Interval -1.75 to -1.59	-1.82 Scores on a scale Interval -1.91 to -1.73	-1.86 Scores on a scale Interval -1.96 to -1.76

SECONDARY outcome

Timeframe: 12 months

Population: The MTX adherent comparative safety analysis set comprised of participants who satisfied the inclusion criteria and had received XELJANZ Tablets 5 mg or other treatment at least once for the treatment of poorly controlled RA despite continuous use of MTX.

Comparison of time to serious infection between XELJANZ group and control group. Hazard ratio (unadjusted): Baseline characteristics are unadjusted Hazard ratio (adjusted 1): Adjusted by propensity score estimated by logistic regression Hazard ratio (adjusted 2): Adjusted by propensity score estimated by random forest Hazard ratio (adjusted 3): Adjusted by propensity score estimated by logistic regression (with upper limit of weighting) Hazard ratio (adjusted 4): Adjusted by propensity score estimated by random forest (with upper limit of weighting)

Outcome measures

Outcome measures
Measure	XELJANZ (MTX Adherent Safety Analysis Set) n=3731 Participants Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion. The MTX adherent safety analysis set was defined as the participants within the safety analysis set who have been poorly controlled even though MTX was used continuously at a dose of more than 8 mg/week for 3 months or longer.	Control (MTX Adherent Comparative Safety Analysis Set) n=2419 Participants Participants with no experience of treatment with XELJANZ Tablets 5 mg, and received treatment other than XELJANZ Tablets 5 mg for RA were observed for a scheduled period of 36 months. The dosage can be adjusted as per physician's discretion. Participants who did not meet the eligibility criteria and/or were not assessable for safety were excluded.	XELJANZ (MTX Adherent Efficacy Analysis Set) At 12 Months From Baseline Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion.	XELJANZ (MTX Adherent Efficacy Analysis Set) At 24 Months From Baseline Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion.	XELJANZ (MTX Adherent Efficacy Analysis Set) At 36 Months From Baseline Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion.
Occurrence of Serious Infection Events	6.86 Incidence rate; participants /100 PY Interval 5.96 to 7.86	1.42 Incidence rate; participants /100 PY Interval 0.97 to 2.0	—	—	—

SECONDARY outcome

Timeframe: 36 months

Comparison of time to malignancy between XELJANZ group and control group. The standard incidence ratio (SIR) was calculated using the general Japanese population as the reference population. Hazard ratio (unadjusted): Baseline characteristics are unadjusted Hazard ratio (adjusted 1): Adjusted by propensity score estimated by logistic regression Hazard ratio (adjusted 2): Adjusted by propensity score estimated by random forest Hazard ratio (adjusted 3): Adjusted by propensity score estimated by logistic regression (with upper limit of weighting) Hazard ratio (adjusted 4): Adjusted by propensity score estimated by random forest (with upper limit of weighting)

Outcome measures

Outcome measures
Measure	XELJANZ (MTX Adherent Safety Analysis Set) n=3731 Participants Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion. The MTX adherent safety analysis set was defined as the participants within the safety analysis set who have been poorly controlled even though MTX was used continuously at a dose of more than 8 mg/week for 3 months or longer.	Control (MTX Adherent Comparative Safety Analysis Set) n=2419 Participants Participants with no experience of treatment with XELJANZ Tablets 5 mg, and received treatment other than XELJANZ Tablets 5 mg for RA were observed for a scheduled period of 36 months. The dosage can be adjusted as per physician's discretion. Participants who did not meet the eligibility criteria and/or were not assessable for safety were excluded.	XELJANZ (MTX Adherent Efficacy Analysis Set) At 12 Months From Baseline Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion.	XELJANZ (MTX Adherent Efficacy Analysis Set) At 24 Months From Baseline Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion.	XELJANZ (MTX Adherent Efficacy Analysis Set) At 36 Months From Baseline Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion.
Occurrence of Malignancy Incidence rate	1.40 Incidence rate; participants /100 PY Interval 1.18 to 1.66	0.88 Incidence rate; participants /100 PY Interval 0.66 to 1.15	—	—	—
Occurrence of Malignancy SIR	1.38 Incidence rate; participants /100 PY Interval 1.16 to 1.62	0.98 Incidence rate; participants /100 PY Interval 0.73 to 1.28	—	—	—

SECONDARY outcome

Timeframe: 36 months

Comparison of time to death between XELJANZ group and control group. The standardized mortality ratio (SMR) was calculated using the general Japanese population as the reference population. Hazard ratio (unadjusted): Baseline characteristics are unadjusted

Outcome measures

Outcome measures
Measure	XELJANZ (MTX Adherent Safety Analysis Set) n=3731 Participants Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion. The MTX adherent safety analysis set was defined as the participants within the safety analysis set who have been poorly controlled even though MTX was used continuously at a dose of more than 8 mg/week for 3 months or longer.	Control (MTX Adherent Comparative Safety Analysis Set) n=2419 Participants Participants with no experience of treatment with XELJANZ Tablets 5 mg, and received treatment other than XELJANZ Tablets 5 mg for RA were observed for a scheduled period of 36 months. The dosage can be adjusted as per physician's discretion. Participants who did not meet the eligibility criteria and/or were not assessable for safety were excluded.	XELJANZ (MTX Adherent Efficacy Analysis Set) At 12 Months From Baseline Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion.	XELJANZ (MTX Adherent Efficacy Analysis Set) At 24 Months From Baseline Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion.	XELJANZ (MTX Adherent Efficacy Analysis Set) At 36 Months From Baseline Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion.
Occurrence of Death Mortality rate	0.89 Mortality rate; participants /100 PY Interval 0.72 to 1.1	0.26 Mortality rate; participants /100 PY Interval 0.15 to 0.43	—	—	—
Occurrence of Death SMR	1.02 Mortality rate; participants /100 PY Interval 0.82 to 1.26	0.39 Mortality rate; participants /100 PY Interval 0.23 to 0.64	—	—	—

Adverse Events

XELJANZ (Safety Analysis Set)

Serious events: 1351 serious events

Other events: 1340 other events

Deaths: 188 deaths

XELJANZ (MTX Adherent Comparative Safety Analysis Set)

Serious events: 773 serious events

Other events: 814 other events

Deaths: 98 deaths

Control (MTX Adherent Comparative Safety Analysis Set)

Serious events: 112 serious events

Other events: 28 other events

Deaths: 16 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	XELJANZ (Safety Analysis Set) n=7021 participants at risk Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months or 6 months. The dosage can be adjusted as per physician's discretion. Participants who did not meet the eligibility criteria and/or were not assessable for safety were excluded.	XELJANZ (MTX Adherent Comparative Safety Analysis Set) n=3731 participants at risk Participants who received XELJANZ Tablets 5 mg as indicated in the approved local product document were observed for a scheduled period of 36 months. The dosage can be adjusted as per physician's discretion. The MTX adherent comparative safety analysis set was defined as the participants with RA who have been poorly controlled even though MTX was used continuously at a dose of more than 8 mg/week for 3 months or longer, excluding the participants with observation for 6 months or shorter.	Control (MTX Adherent Comparative Safety Analysis Set) n=2419 participants at risk Participants with no experience of treatment with XELJANZ Tablets 5 mg, and received treatment other than XELJANZ Tablets 5 mg for RA were observed for a scheduled period of 36 months. The dosage can be adjusted as per physician's discretion. Participants who did not meet the eligibility criteria and/or were not assessable for safety were excluded.
Hepatobiliary disorders Hepatic function abnormal	4.0% 284/7021 • 36 months The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.	5.2% 194/3731 • 36 months The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.	0.12% 3/2419 • 36 months The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Bronchitis	2.4% 167/7021 • 36 months The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.	2.6% 98/3731 • 36 months The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.	0.08% 2/2419 • 36 months The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Herpes zoster	7.8% 547/7021 • 36 months The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.	8.7% 325/3731 • 36 months The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.	0.62% 15/2419 • 36 months The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Nasopharyngitis	2.9% 203/7021 • 36 months The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.	3.3% 124/3731 • 36 months The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.	0.04% 1/2419 • 36 months The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Lymphocyte count decreased	2.4% 170/7021 • 36 months The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.	2.5% 95/3731 • 36 months The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.	0.00% 0/2419 • 36 months The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	3.0% 214/7021 • 36 months The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.	3.3% 124/3731 • 36 months The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.	0.29% 7/2419 • 36 months The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

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 disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER