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| ID | Type | Description | Link |
|---|---|---|---|
| ESCALATE-RA | Other Identifier | Alias Study Number |
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This non-interventional study aims to identify key factors that are driving treatment decisions by rheumatologists in the treatment of rheumatoid arthritis (RA) patients starting treatment with Tofacitinib in a real world setting.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib | Drug | Patients who are started on Tofacitinib treatment according to the drug label |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Escalations | Treatment escalations was defined as participants who switched to another disease modifying antirheumatic drug (DMARD) or combination of DMARDs when compared to the last visit. The following three types of escalations were reported: treatment termination, treatment step-up/switch and treatment step-down. Treatment termination was defined as the termination of a DMARD (or multiple when on combination therapy) without starting a new DMARD therapy. Treatment step-up/switch was defined as an increase from the current treatment regime towards e.g.a combination of DMARDs and treatment step-down, was defined as de-escalation from the current treatment regime, example (e.g.) from combination therapy to monotherapy. One participant can fall into more than 1 type of escalation. | From date of first prescription of tofacitinib up to 24 Months |
| Time to Treatment Escalation | Time to treatment escalation was defined as time in days from escalation visit date to next escalation visit date. The following three types of escalations were reported: treatment termination, treatment step-up/switch and treatment step-down. Treatment termination was defined as the termination of a DMARD (or multiple when on combination therapy) without starting a new DMARD therapy. Treatment step-up/switch was defined as an increase from the current treatment regime (monotherapy) towards a combination of DMARDs and treatment step-down, was defined as de-escalation from the current treatment regime, e.g. from combination therapy to monotherapy. Number of participants with total number of each type of treatment escalations during the study (step-up/switch, step-down, treatment termination along with all escalations) are reported in this outcome measure. | From date of first prescription of tofacitinib up to 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Step Up Treatment Escalation | Time to first step-up treatment escalation was defined for participants who experienced a treatment step-up and was measured as date of first treatment step up escalation minus (-) date of first prescription of tofacitinib. Treatment step-up was defined as an increase from the current treatment regime (monotherapy) towards a combination of DMARDs. | From date of first tofacitinib prescription up to date of first step-up treatment escalation (maximum up to 24 months) |
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Inclusion Criteria:
Patients aged ≥ 18 years
Confirmed Diagnosis of Rheumatoid Arthritis by rheumatologist
Patient is eligible for Tofacitinib treatment according to Summary of Product Characteristics (SmPC)
Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria:
Contraindications according to Xeljanz® SmPC
Receipt of any investigational drug within 3 months before study inclusion
Patients who have received any previous treatment with Tofacitinib or other JAK inhibitors
Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the study.
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Adult patients with confirmed diagnosis of rheumatoid arthritis who are eligible for treatment with Tofacitinb according to Summary of Product Characteristics (SmPC)
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Praxis | Düsseldorf | North Rhine-Westphalia | 40237 | Germany | ||
| Private Practice |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41689213 | Derived | Krueger K, Behrens F, Brandt-Juergens J, Detert J, Feuchtenberger M, Prothmann U, Behmer O, Hsieh MM, Jobst J, Klaus P, Meng T. Tofacitinib in rheumatoid arthritis: a German real-world study with focus on treatment changes, effectiveness and patient-reported outcomes (ESCALATE-RA). BMJ Open. 2026 Feb 12;16(2):e096952. doi: 10.1136/bmjopen-2024-096952. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Data from German participants with rheumatoid arthritis (RA) who initiated treatment with Tofacitinib or switched to other therapies from initial tofacitinib therapy in real world setting were observed for 24 months in this non-interventional observational study.
Total 1518 participants were screened in this observational study, out of which 1459 eligible participants were enrolled and 59 we excluded. Out of these 59 participants, 30 participants were excluded due to retrospective screening failure and data review meeting decision as the type of therapy (monotherapy or combination therapy) was not defined and 29 participants were not eligible as their treatment with Tofacitinib was not started.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tofacitinib Monotherapy | Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 23, 2017 | Jul 12, 2024 |
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| Number of Participants Achieving Low Disease Activity (LDA) as Assessed by Simplified Disease Activity Index (SDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 | SDAI was calculated using the following formula: SDAI = Tender Joint Count (TJC) (using 28 joints) + Swollen Joint Count (SJC) (using 28 joints) + Patient Global Assessment of Arthritis (PtGA) (0-10 centimetre [cm] scale) + Physician's Global Assessment of Arthritis (PhGA) (0-10 cm scale) + C-reactive protein (CRP) (milligram per decilitre [mg/dL]). TJC28 joints included shoulders, elbows, wrists, metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm visual analogue scale (VAS) scale (0 cm [very well] to 10 cm [worst], where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of less than or equal to (<=11) indicates LDA. | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
| Number of Participants Achieving LDA as Assessed by Clinical Disease Activity Index (CDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 | CDAI was calculated using the following formula: CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm). TJC28 joints included shoulders, elbows, wrists, MCP and proximal PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm [very well] to 10 cm [worst], where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <= 10 indicates LDA. | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
| Number of Participants Achieving LDA Based on Disease Activity Score (DAS28-4) Erythrocyte Sedimentation Rate (ESR) at Months 3, 6, 9, 12, 15, 18, 21 and 24 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56* square root of (TJC28) + 0.28* square root of (SJC28) + 0.70* natural log (ln) (ESR in [millimeter per hour [mm/ hour]) + 0.014*(PtGA in cm). PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 ESR <= 3.2 indicates LDA.](streamdown:incomplete-link) | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
| Number of Participants Achieving LDA as Based on DAS28-4 C-Reactive Protein (CRP) at Months 3, 6, 9, 12, 15, 18, 21 and 24 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56* square root of (TJC28) + 0.28* square root of (SJC28) + 0.36*ln (CRP in mg/l +1) + 0.014*(PtGA in mm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 CRP <= 3.2 indicates LDA. | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
| Number of Participants Achieving Remission as Assessed by American College of Rheumatology (ACR)-EULAR Boolean Remission Criteria at Months 3, 6, 9, 12, 15, 18, 21 and 24 | ACR-EULAR Boolean remission criteria was defined as when participant had ACR remission =1 if; TJC28 <=1, SJC28 <=1, CRP <=1mg/dL and PtGA <= 2 cm on a 0 to 10 cm scale, where higher values indicate greater affection due to disease activity. | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
| Number of Participants Achieving Remission as Assessed by SDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 | SDAI was calculated using the following formula: SDAI = (TJC28) + (SJC28) + (PtGA in cm) + (PhGA in cm) + (CRP in mg/dL). TJC28 joints included shoulders, elbows, wrists, MCP and PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm [very well] to 10 cm [worst], where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=3.3 indicates remission. | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
| Number of Participants Achieving Remission as Assessed by CDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 | CDAI was calculated using the following formula: CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm). TJC28 joints included shoulders, elbows, wrists, MCP and proximal PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm [very well] to 10 cm [worst], where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=2.8 indicates remission. | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
| Number of Participants Achieving Remission as Assessed by DAS-28 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56*square root of (TJC28) + 0.28*square root of (SJC28) + 0.70*In (ESR in mm/ hour) + 0.014*PtGA in cm. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 ESR score of <2.6 indicates remission. | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
| Number of Participants Achieving Remission as Assessed by DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56*square root of (TJC28) + 0.28*square root of (SJC28) + 0.36*ln (CRP in mg/l +1) + 0.014*(PtGA in cm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 CRP score of <2.6 indicates remission. | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
| Change From Baseline in DAS28-4 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56*square root of (TJC28) + 0.28*square root of (SJC28) + 0.70*In (ESR in mm/ hour) + 0.014*PtGA in cm. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. | Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 |
| Change From Baseline in DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56*square root of(TJC28) + 0.28*square root of(SJC28) + 0.36*ln (CRP in mg/l +1) + 0.014*(PtGA in cm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. | Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 |
| Change From Baseline in Duration of Morning Stiffness at Months 3, 6, 9, 12, 15, 18, 21 and 24 | The duration of morning stiffness was determined by asking the following questions: "When you wake up in the morning, do you currently suffer from morning stiffness?" "How long does the morning stiffness last from the time you wake up?". The change from baseline in duration of morning stiffness was calculated as: morning stiffness at time point -morning stiffness at baseline. | Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 |
| Change From Baseline in the Functional Ability Questionnaire Hannover (FFbH) at Months 3, 6, 9, 12, 15, 18, 21 and 24 | The FFbH for RA is a German short questionnaire for the assessment of patientive functional capacity in the context of basic everyday activities (range: 0-100% functional capacity, where higher percentage indicates more capacity for everyday activities). The FFbH questionnaire consisted of 18 questions with 3 possible responses (Yes; Yes, but with effort; No or only with outside help). The total score was the sum of the scores of all 18 questions, where for each question (Yes = 2 points; Yes, but with effort = 1 point; No or only with outside help = 0 points).The functional capacity (%) is calculated by (total score*100) divided by (2*number of valid responses). The change from baseline was calculated at each time point as functional capacity at timepoint - functional capacity at baseline. | Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 |
| Number of Participants Achieving Functional Remission in FFbH at Months 3, 6, 9, 12, 15, 18, 21 and 24 | The FFbH for RA is a German short questionnaire for the assessment of patientive functional capacity in the context of basic everyday activities (range: 0-100% functional capacity, where higher percentage indicates more capacity for everyday activities). The FFbH questionnaire consisted of 18 questions with 3 possible responses (Yes; Yes, but with effort; No or only with outside help). The total score was the sum of the scores of all 18 questions, where for each question (Yes = 2 points; Yes, but with effort = 1 point; No or only with outside help = 0 points). The functional capacity [%] is calculated by (total score*100)/ (2*number of valid responses). Functional remission in FFbH was defined as functional capacity > 83 %. | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
| Change From Baseline in European Quality of Life (EuroQoL) Group EuroQoL- 5 Dimensions- 3 Levels (EQ-5D-3L) Total Scores at Months 3, 6, 9, 12, 15, 18, 21 and 24 | The EQ-5D-3L is a standardised instrument used to measure quality of life. It is based on five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. Scoring formula developed by EuroQol Group (German weights) assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of 0.05 to 1.00; higher scores indicating a better health state. | Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale at Months 3, 6, 9, 12, 15, 18, 21 and 24 | The FACIT-F Scale is a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue). | Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 |
| Mean Number of Days of Drug Survival at Months 12 and 24 | Drug survival was assessed using Kaplan-Meier methodology. For participants who terminated tofacitinib, the drug survival status was recorded as (status = 1 and time = termination date tofacitinib - date of initiation on tofacitinib) and for participants who do not terminate tofacitinib (status = 0 and time = date of final visit - date of initiation on tofacitinib. | At 12 and 24 months |
| Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 | Satisfaction with treatment was assessed on a 5-point Likert scale (where 0 = extremely dissatisfied, 1= dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = extremely satisfied) in response to the question "How satisfied are you with the drugs that you have received for your arthritis since your last visit?". | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
| Zschopau |
| Saxony |
| 09405 |
| Germany |
| Private Practice Kupka | Altenburg | 04600 | Germany |
| Private Practise Boehm | Altenholz | 24161 | Germany |
| Private Practice Marycz | Amberg | 92224 | Germany |
| Private Practice Fuchs | Augsburg | 86157 | Germany |
| private practise Gause | Bad Bramstedt | 24576 | Germany |
| ACURA Kliniken Rheinland-Pfalz AG | Bad Kreuznach | 55543 | Germany |
| MFZ Medizinisches Forschungszentrum Weserbergland | Bad Pyrmont | 31812 | Germany |
| Private Practice Manger | Bamberg | 96047 | Germany |
| Private Practice Ochs | Bayreuth | 95444 | Germany |
| Private Practice Schmitt-Haendle | Bayreuth | 95444 | Germany |
| Private Practice | Bayreuth | 95444 | Germany |
| Ambulantes Gesundheitszentrum der Charité | Berlin | 10117 | Germany |
| Private Practice Bozorg | Berlin | 10713 | Germany |
| Private Practice Brandt-Juergens | Berlin | 12161 | Germany |
| Privat Practice Remstedt | Berlin | 12435 | Germany |
| private practise Herzberg | Berlin | 12435 | Germany |
| Private Practice Seifert | Berlin | 12555 | Germany |
| Private Practice Zinke | Berlin | 13055 | Germany |
| Private Practice Thiele | Berlin | 14129 | Germany |
| Immanuel Klinikum Bernau | Bernau | 16321 | Germany |
| Private Practise | Braunschweig | 38100 | Germany |
| MED Bayern OST GmbH | Burghausen | 84489 | Germany |
| Private Practice Lorenz | Chemnitz | 09139 | Germany |
| Private Practice Baerlecken | Cologne | 50996 | Germany |
| Private Practice Kirrstetter | Deggendorf | 94469 | Germany |
| Kreiskranenhaus Demmin GmbH | Demmin | 17109 | Germany |
| Private Practice Menne | Dortmund | 44263 | Germany |
| Private Practice Luethke | Dresden | 01097 | Germany |
| Private Practice Fischer | Dresden | 01277 | Germany |
| private practise Pech | Eberswalde | 16225 | Germany |
| Private Practice Steinmueller | Ehringshausen | 35630 | Germany |
| Asklepios MVZ Nord SH GmbH, c/o AK St. Georg | Elmshorn | 25335 | Germany |
| Private Practice Kaestner | Erfurt | 99096 | Germany |
| Private Practice Koch | Erfurt | 99096 | Germany |
| Private Practice Haeckel | Frankenberg | 09669 | Germany |
| Private Practice Mueller | Freiberg | 09599 | Germany |
| SRH Krankenhaus Waltershausen-Friedrichroda GmbH | Friedrichroda | 99894 | Germany |
| Private Practice Abahji | Germering | 82110 | Germany |
| Private Practice Sensse | Gifhorn | 38518 | Germany |
| Private Practice Holst | Glaisin | 19288 | Germany |
| Private Practice Zeh | Göppingen | 73033 | Germany |
| Private Practice Semmler | Güstrow | 18273 | Germany |
| private practise Kühne | Haldensleben I | 39340 | Germany |
| Private Practice Liebhaber | Halle | 06128 | Germany |
| Private Practice Dahmen | Hamburg | 22415 | Germany |
| private practise Aries | Hamburg | 22767 | Germany |
| Private Practice Stille | Hanover | 30161 | Germany |
| private practise Heilig | Heidelberg | 69120 | Germany |
| private practise Wernicke | Hohen Neuendorf | 16540 | Germany |
| Private Practice Kremers | Jülich | 52428 | Germany |
| Medius Kliniken gGmbH | Kirchheim unter Teck | 73230 | Germany |
| Kreiskrankenhaus Langenau | Langenau | 89129 | Germany |
| Private Practice Hamann | Leipzig | 04109 | Germany |
| Private Practice Schwarze | Leipzig | 04129 | Germany |
| Private Practice Kudela | Magdeburg | 39104 | Germany |
| private practise Sieburg | Magdeburg | 39104 | Germany |
| Private Practice Rossbach | Mansfeld | 06343 | Germany |
| Private Practice Harmuth | Marktredwitz | 95615 | Germany |
| Private Practice Worsch | Mühlhausen | 99974 | Germany |
| Private Practice Krueger | München | 81541 | Germany |
| Private Practice Raub | Münster | 48143 | Germany |
| Praxis Dr.med. Holger Krauel Facharzt für Innere Medizin und Rheumatologie | Naumburg | 06618 | Germany |
| Private Practice Berger | Naunhof | 04683 | Germany |
| Private Practise | Neubrandenburg | 17033 | Germany |
| Private Practice Volberg | Neuss | 41462 | Germany |
| MCN Medic Center Nuernberg GmbH | Nuremberg | 90443 | Germany |
| Private Practice Goettl | Passau | 94032 | Germany |
| Private Practice Graessler | Pirna | 01796 | Germany |
| Private Practice Baumann | Plauen | 08523 | Germany |
| Knappschaftsklinikum Soor, Klinik fuer Rheumatologie und Klinische Immunologie | Püttlingen | 66346 | Germany |
| Private Practice Wassenberg, Koehler, Weier | Ratingen | 40878 | Germany |
| Private Practice Richter | Rostock | 18059 | Germany |
| private practise Biewer | Saarbrücken | 66111 | Germany |
| MVZ Dialysezentrum Schweinfurt | Schweinfurt | 97421 | Germany |
| Private Practice Moebius | Schwerin | 19053 | Germany |
| Private Practice | Schwerin | 19053 | Germany |
| private practise Ständer | Schwerin | 19053 | Germany |
| Private Practice Melzer | Seesen | 38723 | Germany |
| MVZ Klinikum Straubing | Straubing | 94315 | Germany |
| Private Practice | Templin | 17268 | Germany |
| Private Practice Pyra | Torgelow | 17358 | Germany |
| Private Practice Haas | Tübingen | 72072 | Germany |
| Klinik an der Weissenburg GmbH | Uhlstaedt-Kirchhasel | 07407 | Germany |
| Private Practice Rinaldi | Ulm | 89073 | Germany |
| Private Practice Woerth | Wiesbaden | 65189 | Germany |
| Klinikverbund St. Antonius und St. Josef GmbH | Wuppertal | 42105 | Germany |
| Rheuma Praxis Barmen Dres. med. Demirel / Hruschka | Wuppertal | 42285 | Germany |
| Private Practice Fricke-Wagner | Zwickau | 08056 | Germany |
| Private Practice Alliger | Zwiesel | 94227 | Germany |
| Tofacitinib+Methotrexate (MTX) Combination Therapy |
Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| FG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| FG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
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| NOT COMPLETED |
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Baseline analysis population included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tofacitinib Monotherapy | Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| BG001 | Tofacitinib+Methotrexate (MTX) Combination Therapy | Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| BG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| BG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Number of Participants With Treatment Escalations | Treatment escalations was defined as participants who switched to another disease modifying antirheumatic drug (DMARD) or combination of DMARDs when compared to the last visit. The following three types of escalations were reported: treatment termination, treatment step-up/switch and treatment step-down. Treatment termination was defined as the termination of a DMARD (or multiple when on combination therapy) without starting a new DMARD therapy. Treatment step-up/switch was defined as an increase from the current treatment regime towards e.g.a combination of DMARDs and treatment step-down, was defined as de-escalation from the current treatment regime, example (e.g.) from combination therapy to monotherapy. One participant can fall into more than 1 type of escalation. | Full analysis set (FAS) included all participants who received at least 1 dose of tofacitinib and had at least 1 set of post-baseline measurements. | Posted | Count of Participants | Participants | From date of first prescription of tofacitinib up to 24 Months |
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| Primary | Time to Treatment Escalation | Time to treatment escalation was defined as time in days from escalation visit date to next escalation visit date. The following three types of escalations were reported: treatment termination, treatment step-up/switch and treatment step-down. Treatment termination was defined as the termination of a DMARD (or multiple when on combination therapy) without starting a new DMARD therapy. Treatment step-up/switch was defined as an increase from the current treatment regime (monotherapy) towards a combination of DMARDs and treatment step-down, was defined as de-escalation from the current treatment regime, e.g. from combination therapy to monotherapy. Number of participants with total number of each type of treatment escalations during the study (step-up/switch, step-down, treatment termination along with all escalations) are reported in this outcome measure. | FAS included all participants who received at least 1 dose of tofacitinib and had at least 1 set of post-baseline measurements. Here" Number analyzed" signifies participants evaluable for specific rows. | Posted | Mean | Standard Deviation | Days | From date of first prescription of tofacitinib up to 24 Months |
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| Secondary | Time to First Step Up Treatment Escalation | Time to first step-up treatment escalation was defined for participants who experienced a treatment step-up and was measured as date of first treatment step up escalation minus (-) date of first prescription of tofacitinib. Treatment step-up was defined as an increase from the current treatment regime (monotherapy) towards a combination of DMARDs. | FAS included all participants who received at least 1 dose of tofacitinib and had at least 1 set of post-baseline measurements. | Posted | Mean | Standard Error | Days | From date of first tofacitinib prescription up to date of first step-up treatment escalation (maximum up to 24 months) |
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| Secondary | Number of Participants Achieving Low Disease Activity (LDA) as Assessed by Simplified Disease Activity Index (SDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 | SDAI was calculated using the following formula: SDAI = Tender Joint Count (TJC) (using 28 joints) + Swollen Joint Count (SJC) (using 28 joints) + Patient Global Assessment of Arthritis (PtGA) (0-10 centimetre [cm] scale) + Physician's Global Assessment of Arthritis (PhGA) (0-10 cm scale) + C-reactive protein (CRP) (milligram per decilitre [mg/dL]). TJC28 joints included shoulders, elbows, wrists, metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm visual analogue scale (VAS) scale (0 cm [very well] to 10 cm [worst], where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of less than or equal to (<=11) indicates LDA. | Secondary FAS (SFAS): all participants who received at least 1 dose of tofacitinib, had >=1 set of post-baseline values & whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row. | Posted | Count of Participants | Participants | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Number of Participants Achieving LDA as Assessed by Clinical Disease Activity Index (CDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 | CDAI was calculated using the following formula: CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm). TJC28 joints included shoulders, elbows, wrists, MCP and proximal PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm [very well] to 10 cm [worst], where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <= 10 indicates LDA. | SFAS: all participants who received at least 1 dose of tofacitinib, had >=1 set of post-baseline values & whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row. | Posted | Count of Participants | Participants | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Number of Participants Achieving LDA Based on Disease Activity Score (DAS28-4) Erythrocyte Sedimentation Rate (ESR) at Months 3, 6, 9, 12, 15, 18, 21 and 24 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56* square root of (TJC28) + 0.28* square root of (SJC28) + 0.70* natural log (ln) (ESR in [millimeter per hour [mm/ hour]) + 0.014*(PtGA in cm). PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 ESR <= 3.2 indicates LDA.](streamdown:incomplete-link) | SFAS: all participants who received at least 1 dose of tofacitinib, had >=1 set of post-baseline values & whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row. | Posted | Count of Participants | Participants | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Number of Participants Achieving LDA as Based on DAS28-4 C-Reactive Protein (CRP) at Months 3, 6, 9, 12, 15, 18, 21 and 24 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56* square root of (TJC28) + 0.28* square root of (SJC28) + 0.36*ln (CRP in mg/l +1) + 0.014*(PtGA in mm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 CRP <= 3.2 indicates LDA. | SFAS: all participants who received at least 1 dose of tofacitinib, had >=1 set of post-baseline values & whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row. | Posted | Count of Participants | Participants | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Number of Participants Achieving Remission as Assessed by American College of Rheumatology (ACR)-EULAR Boolean Remission Criteria at Months 3, 6, 9, 12, 15, 18, 21 and 24 | ACR-EULAR Boolean remission criteria was defined as when participant had ACR remission =1 if; TJC28 <=1, SJC28 <=1, CRP <=1mg/dL and PtGA <= 2 cm on a 0 to 10 cm scale, where higher values indicate greater affection due to disease activity. | SFAS: all participants who received at least 1 dose of tofacitinib, had >=1 set of post-baseline values & whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row. | Posted | Count of Participants | Participants | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Number of Participants Achieving Remission as Assessed by SDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 | SDAI was calculated using the following formula: SDAI = (TJC28) + (SJC28) + (PtGA in cm) + (PhGA in cm) + (CRP in mg/dL). TJC28 joints included shoulders, elbows, wrists, MCP and PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm [very well] to 10 cm [worst], where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=3.3 indicates remission. | SFAS: all participants who received at least 1 dose of tofacitinib, had >=1 set of post-baseline values & whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row. | Posted | Count of Participants | Participants | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Number of Participants Achieving Remission as Assessed by CDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 | CDAI was calculated using the following formula: CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm). TJC28 joints included shoulders, elbows, wrists, MCP and proximal PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm [very well] to 10 cm [worst], where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=2.8 indicates remission. | SFAS: all participants who received at least 1 dose of tofacitinib, had >=1 set of post-baseline values & whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row. | Posted | Count of Participants | Participants | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Number of Participants Achieving Remission as Assessed by DAS-28 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56*square root of (TJC28) + 0.28*square root of (SJC28) + 0.70*In (ESR in mm/ hour) + 0.014*PtGA in cm. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 ESR score of <2.6 indicates remission. | SFAS: all participants who received at least 1 dose of tofacitinib, had >=1 set of post-baseline values & whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row. | Posted | Count of Participants | Participants | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Number of Participants Achieving Remission as Assessed by DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56*square root of (TJC28) + 0.28*square root of (SJC28) + 0.36*ln (CRP in mg/l +1) + 0.014*(PtGA in cm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 CRP score of <2.6 indicates remission. | SFAS: all participants who received at least 1 dose of tofacitinib, had >=1 set of post-baseline values & whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row. | Posted | Count of Participants | Participants | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Change From Baseline in DAS28-4 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56*square root of (TJC28) + 0.28*square root of (SJC28) + 0.70*In (ESR in mm/ hour) + 0.014*PtGA in cm. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. | SFAS: all participants who received at least 1 dose of tofacitinib, had >=1 set of post-baseline values & whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Change From Baseline in DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56*square root of(TJC28) + 0.28*square root of(SJC28) + 0.36*ln (CRP in mg/l +1) + 0.014*(PtGA in cm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. | SFAS: all participants who received at least 1 dose of tofacitinib, had >=1 set of post-baseline values & whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Change From Baseline in Duration of Morning Stiffness at Months 3, 6, 9, 12, 15, 18, 21 and 24 | The duration of morning stiffness was determined by asking the following questions: "When you wake up in the morning, do you currently suffer from morning stiffness?" "How long does the morning stiffness last from the time you wake up?". The change from baseline in duration of morning stiffness was calculated as: morning stiffness at time point -morning stiffness at baseline. | SFAS: all participants who received at least 1 dose of tofacitinib, had >=1 set of post-baseline values & whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row. | Posted | Mean | Standard Deviation | Minutes | Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Change From Baseline in the Functional Ability Questionnaire Hannover (FFbH) at Months 3, 6, 9, 12, 15, 18, 21 and 24 | The FFbH for RA is a German short questionnaire for the assessment of patientive functional capacity in the context of basic everyday activities (range: 0-100% functional capacity, where higher percentage indicates more capacity for everyday activities). The FFbH questionnaire consisted of 18 questions with 3 possible responses (Yes; Yes, but with effort; No or only with outside help). The total score was the sum of the scores of all 18 questions, where for each question (Yes = 2 points; Yes, but with effort = 1 point; No or only with outside help = 0 points).The functional capacity (%) is calculated by (total score*100) divided by (2*number of valid responses). The change from baseline was calculated at each time point as functional capacity at timepoint - functional capacity at baseline. | SFAS: all participants who received at least 1 dose of tofacitinib, had >=1 set of post-baseline values & whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row. | Posted | Mean | Standard Deviation | Percent functional capacity | Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Number of Participants Achieving Functional Remission in FFbH at Months 3, 6, 9, 12, 15, 18, 21 and 24 | The FFbH for RA is a German short questionnaire for the assessment of patientive functional capacity in the context of basic everyday activities (range: 0-100% functional capacity, where higher percentage indicates more capacity for everyday activities). The FFbH questionnaire consisted of 18 questions with 3 possible responses (Yes; Yes, but with effort; No or only with outside help). The total score was the sum of the scores of all 18 questions, where for each question (Yes = 2 points; Yes, but with effort = 1 point; No or only with outside help = 0 points). The functional capacity [%] is calculated by (total score*100)/ (2*number of valid responses). Functional remission in FFbH was defined as functional capacity > 83 %. | SFAS: all participants who received at least 1 dose of tofacitinib, had >=1 set of post-baseline values & whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row. | Posted | Count of Participants | Participants | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Change From Baseline in European Quality of Life (EuroQoL) Group EuroQoL- 5 Dimensions- 3 Levels (EQ-5D-3L) Total Scores at Months 3, 6, 9, 12, 15, 18, 21 and 24 | The EQ-5D-3L is a standardised instrument used to measure quality of life. It is based on five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. Scoring formula developed by EuroQol Group (German weights) assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of 0.05 to 1.00; higher scores indicating a better health state. | SFAS: all participants who received at least 1 dose of tofacitinib, had >=1 set of post-baseline values & whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale at Months 3, 6, 9, 12, 15, 18, 21 and 24 | The FACIT-F Scale is a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue). | SFAS: all participants who received at least 1 dose of tofacitinib, had >=1 set of post-baseline values & whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24 |
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| Secondary | Mean Number of Days of Drug Survival at Months 12 and 24 | Drug survival was assessed using Kaplan-Meier methodology. For participants who terminated tofacitinib, the drug survival status was recorded as (status = 1 and time = termination date tofacitinib - date of initiation on tofacitinib) and for participants who do not terminate tofacitinib (status = 0 and time = date of final visit - date of initiation on tofacitinib. | FAS included all participants who received at least 1 dose of tofacitinib and have at least 1 set of post-baseline measurements. Here" Number Analyzed" = participants evaluable for specified rows. | Posted | Mean | Standard Error | Days | At 12 and 24 months |
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| Secondary | Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 | Satisfaction with treatment was assessed on a 5-point Likert scale (where 0 = extremely dissatisfied, 1= dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = extremely satisfied) in response to the question "How satisfied are you with the drugs that you have received for your arthritis since your last visit?". | SFAS: all participants who received at least 1 dose of tofacitinib, had >=1 set of post-baseline values & whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row. | Posted | Count of Participants | Participants | Months 3, 6, 9, 12, 15, 18, 21 and 24 |
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From date of first prescription of tofacitinib up to 24 months (maximum up to 24 Months)
The safety analysis set included all participants who had received at least one dose of tofacitinib.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Tofacitinib Monotherapy | Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. | 6 | 779 | 141 | 779 | 402 | 779 |
| EG001 | Tofacitinib+Methotrexate (MTX) Combination Therapy | Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. | 5 | 440 | 69 | 440 | 240 | 440 |
| EG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. | 0 | 111 | 24 | 111 | 81 | 111 |
| EG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. | 0 | 129 | 27 | 129 | 84 | 129 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug ineffective | General disorders | MedDRA v23.1 | Non-systematic Assessment |
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| Therapeutic product effect incomplete | General disorders | MedDRA v23.1 | Non-systematic Assessment |
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| Therapeutic product effect decreased | General disorders | MedDRA v23.1 | Non-systematic Assessment |
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| Drug intolerance | General disorders | MedDRA v23.1 | Non-systematic Assessment |
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| Death | General disorders | MedDRA v23.1 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA v23.1 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA v23.1 | Non-systematic Assessment |
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| Impaired healing | General disorders | MedDRA v23.1 | Non-systematic Assessment |
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| Condition aggravated | General disorders | MedDRA v23.1 | Non-systematic Assessment |
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| Systemic inflammatory response syndrome | General disorders | MedDRA v23.1 | Non-systematic Assessment |
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| Withdrawal syndrome | General disorders | MedDRA v23.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA v23.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
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| Bursitis infective | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
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| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
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| Peritonitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Whipple's disease | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abscess oral | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hepatitis E | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Herpes pharyngitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Medical device site infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Medical device site joint infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Arthrofibrosis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Carpal collapse | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rheumatoid nodule | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tenosynovitis stenosans | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Aneurysm | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Iliac artery stenosis | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Medication error | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Product dose omission issue | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Facial paresis | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Ruptured cerebral aneurysm | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lentigo maligna | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Vulval cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Alveolitis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Colon operation | Surgical and medical procedures | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA v23.1 | Non-systematic Assessment |
| |
| Osteotomy | Surgical and medical procedures | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pulmonary resection | Surgical and medical procedures | MedDRA v23.1 | Non-systematic Assessment |
| |
| Spinal fusion surgery | Surgical and medical procedures | MedDRA v23.1 | Non-systematic Assessment |
| |
| Spinal operation | Surgical and medical procedures | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tenoplasty | Surgical and medical procedures | MedDRA v23.1 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Normocytic anaemia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Red blood cell sedimentation rate increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Paraesthesia ear | Ear and labyrinth disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lipoedema | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Corneal oedema | Eye disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hepatosplenomegaly | Hepatobiliary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Contrast media reaction | Immune system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v23.1 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug ineffective | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Therapeutic product effect decreased | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Therapeutic product effect incomplete | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Drug intolerance | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cyst | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Drug tolerance decreased | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Remission not achieved | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Sense of oppression | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Root canal infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Infection susceptibility increased | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Borrelia infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Helicobacter gastritis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Infected bite | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Nasal herpes | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rotavirus infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oral mucosa erosion | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Coating in mouth | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dental discomfort | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Loose tooth | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pancreatic failure | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Regurgitation | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Salivary gland enlargement | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rheumatoid nodule | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Spinal instability | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cauda equina syndrome | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypokinesia | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Intercostal neuralgia | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Movement disorder | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Poor quality sleep | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pseudoradicular syndrome | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Butterfly rash | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Granuloma annulare | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Perioral dermatitis | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rash maculovesicular | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Borrelia test positive | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase abnormal | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lung diffusion test decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lymphocyte morphology abnormal | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Platelet count abnormal | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pulmonary function test decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Transaminases abnormal | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cough variant asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dyspnoea at rest | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Paranasal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Vocal cord leukoplakia | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Intentional dose omission | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Adverse event following immunisation | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Eye contusion | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Ligament injury | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Mallet finger | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Palate injury | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Product administration error | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood pressure fluctuation | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Vascular pain | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lipid metabolism disorder | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lipoedema | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Folate deficiency | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Apathy | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Generalised anxiety disorder | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Listless | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Panic disorder | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bladder discomfort | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Micturition disorder | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Episcleritis | Eye disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Eyelid thickening | Eye disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Periorbital swelling | Eye disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bone marrow oedema | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Monoclonal B-cell lymphocytosis | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Normocytic anaemia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tachycardia paroxysmal | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pleomorphic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tumour embolism | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Eustachian tube disorder | Ear and labyrinth disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| External ear inflammation | Ear and labyrinth disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Penile oedema | Reproductive system and breast disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Fatty liver alcoholic | Hepatobiliary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Thyroid disorder | Endocrine disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA v23.1 | Non-systematic Assessment |
| |
| Shoulder operation | Surgical and medical procedures | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Synoviorthesis | Surgical and medical procedures | MedDRA v23.1 | Non-systematic Assessment |
| |
| Sensation of oppression | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Joint surgery | Surgical and medical procedures | MedDRA v23.1 | Non-systematic Assessment |
| |
| Formication | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2023 | Jul 12, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C479163 | tofacitinib |
Not provided
Not provided
Not provided
|
|
|
| Step-down |
|
| Treatment termination |
|
| Any escalation |
|
Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
| OG002 |
| Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy |
Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
| OG001 | Tofacitinib+Methotrexate (MTX) Combination Therapy | Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
| OG001 |
| Tofacitinib+Methotrexate (MTX) Combination Therapy |
Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
| OG001 | Tofacitinib+Methotrexate (MTX) Combination Therapy | Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
| OG001 |
| Tofacitinib+Methotrexate (MTX) Combination Therapy |
Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
| OG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
| OG001 |
| Tofacitinib+Methotrexate (MTX) Combination Therapy |
Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
| Tofacitinib+Methotrexate (MTX) Combination Therapy |
Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
| OG001 |
| Tofacitinib+Methotrexate (MTX) Combination Therapy |
Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
| OG001 |
| Tofacitinib+Methotrexate (MTX) Combination Therapy |
Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
| OG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
| OG001 | Tofacitinib+Methotrexate (MTX) Combination Therapy | Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
| OG001 | Tofacitinib+Methotrexate (MTX) Combination Therapy | Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
| OG001 |
| Tofacitinib+Methotrexate (MTX) Combination Therapy |
Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
| OG002 |
| Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy |
Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
|
| OG002 | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
| OG003 | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician. |
|
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Dissatisfied |
|
| Neither satisfied nor dissatisfied |
|
| Satisfied |
|
| Extremely satisfied |
|
| Title | Measurements |
|---|---|
| Extremely dissatisfied |
|
| Dissatisfied |
|
| Neither satisfied nor dissatisfied |
|
| Satisfied |
|
| Extremely satisfied |
|
| Title | Measurements |
|---|---|
| Extremely dissatisfied |
|
| Dissatisfied |
|
| Neither satisfied nor dissatisfied |
|
| Satisfied |
|
| Extremely satisfied |
|
| Title | Measurements |
|---|---|
| Extremely dissatisfied |
|
| Dissatisfied |
|
| Neither satisfied nor dissatisfied |
|
| Satisfied |
|
| Extremely satisfied |
|
| Title | Measurements |
|---|---|
| Extremely dissatisfied |
|
| Dissatisfied |
|
| Neither satisfied nor dissatisfied |
|
| Satisfied |
|
| Extremely satisfied |
|
| Title | Measurements |
|---|---|
| Extremely dissatisfied |
|
| Dissatisfied |
|
| Neither satisfied nor dissatisfied |
|
| Satisfied |
|
| Extremely satisfied |
|
| Title | Measurements |
|---|---|
| Extremely dissatisfied |
|
| Dissatisfied |
|
| Neither satisfied nor dissatisfied |
|
| Satisfied |
|
| Extremely satisfied |
|
| Title | Measurements |
|---|---|
| Extremely dissatisfied |
|
| Dissatisfied |
|
| Neither satisfied nor dissatisfied |
|
| Satisfied |
|
| Extremely satisfied |
|